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Abstract

Background: Most people who stop smoking gain weight. This can discourage some people from making a quit attempt and risks offsetting some, but not all, of the health advantages of quitting. Interventions to prevent weight gain could improve health outcomes, but there is a concern that they may undermine quitting. Objectives: To systematically review the effects of: (1) interventions targeting post-cessation weight gain on weight change and smoking cessation (referred to as 'Part 1') and (2) interventions designed to aid smoking cessation that plausibly affect post-cessation weight gain (referred to as 'Part 2'). Search methods: Part 1 - We searched the Cochrane Tobacco Addiction Group's Specialized Register and CENTRAL; latest search 16 October 2020. Part 2 - We searched included studies in the following 'parent' Cochrane reviews: nicotine replacement therapy (NRT), antidepressants, nicotine receptor partial agonists, e-cigarettes, and exercise interventions for smoking cessation published in Issue 10, 2020 of the Cochrane Library. We updated register searches for the review of nicotine receptor partial agonists. Selection criteria: Part 1 - trials of interventions that targeted post-cessation weight gain and had measured weight at any follow-up point or smoking cessation, or both, six or more months after quit day. Part 2 - trials included in the selected parent Cochrane reviews reporting weight change at any time point. Data collection and analysis: Screening and data extraction followed standard Cochrane methods. Change in weight was expressed as difference in weight change from baseline to follow-up between trial arms and was reported only in people abstinent from smoking. Abstinence from smoking was expressed as a risk ratio (RR). Where appropriate, we performed meta-analysis using the inverse variance method for weight, and Mantel-Haenszel method for smoking. Main results: Part 1: We include 37 completed studies; 21 are new to this update. We judged five studies to be at low risk of bias, 17 to be at unclear risk and the remainder at high risk. An intermittent very low calorie diet (VLCD) comprising full meal replacement provided free of charge and accompanied by intensive dietitian support significantly reduced weight gain at end of treatment compared with education on how to avoid weight gain (mean difference (MD) -3.70 kg, 95% confidence interval (CI) -4.82 to -2.58; 1 study, 121 participants), but there was no evidence of benefit at 12 months (MD -1.30 kg, 95% CI -3.49 to 0.89; 1 study, 62 participants). The VLCD increased the chances of abstinence at 12 months (RR 1.73, 95% CI 1.10 to 2.73; 1 study, 287 participants). However, a second study found that no-one completed the VLCD intervention or achieved abstinence. Interventions aimed at increasing acceptance of weight gain reported mixed effects at end of treatment, 6 months and 12 months with confidence intervals including both increases and decreases in weight gain compared with no advice or health education. Due to high heterogeneity, we did not combine the data. These interventions increased quit rates at 6 months (RR 1.42, 95% CI 1.03 to 1.96; 4 studies, 619 participants; I2 = 21%), but there was no evidence at 12 months (RR 1.25, 95% CI 0.76 to 2.06; 2 studies, 496 participants; I2 = 26%). Some pharmacological interventions tested for limiting post-cessation weight gain (PCWG) reduced weight gain at the end of treatment (dexfenfluramine, phenylpropanolamine, naltrexone). The effects of ephedrine and caffeine combined, lorcaserin, and chromium were too imprecise to give useful estimates of treatment effects. There was very low-certainty evidence that personalized weight management support reduced weight gain at end of treatment (MD -1.11 kg, 95% CI -1.93 to -0.29; 3 studies, 121 participants; I2 = 0%), but no evidence in the longer-term 12 months (MD -0.44 kg, 95% CI -2.34 to 1.46; 4 studies, 530 participants; I2 = 41%). There was low to very low-certainty evidence that detailed weight management education without personalized assessment, planning and feedback did not reduce weight gain and may have reduced smoking cessation rates (12 months: MD -0.21 kg, 95% CI -2.28 to 1.86; 2 studies, 61 participants; I2 = 0%; RR for smoking cessation 0.66, 95% CI 0.48 to 0.90; 2 studies, 522 participants; I2 = 0%). Part 2: We include 83 completed studies, 27 of which are new to this update. There was low certainty that exercise interventions led to minimal or no weight reduction compared with standard care at end of treatment (MD -0.25 kg, 95% CI -0.78 to 0.29; 4 studies, 404 participants; I2 = 0%). However, weight was reduced at 12 months (MD -2.07 kg, 95% CI -3.78 to -0.36; 3 studies, 182 participants; I2 = 0%). Both bupropion and fluoxetine limited weight gain at end of treatment (bupropion MD -1.01 kg, 95% CI -1.35 to -0.67; 10 studies, 1098 participants; I2 = 3%); (fluoxetine MD -1.01 kg, 95% CI -1.49 to -0.53; 2 studies, 144 participants; I2 = 38%; low- and very low-certainty evidence, respectively). There was no evidence of benefit at 12 months for bupropion, but estimates were imprecise (bupropion MD -0.26 kg, 95% CI -1.31 to 0.78; 7 studies, 471 participants; I2 = 0%). No studies of fluoxetine provided data at 12 months. There was moderate-certainty that NRT reduced weight at end of treatment (MD -0.52 kg, 95% CI -0.99 to -0.05; 21 studies, 2784 participants; I2 = 81%) and moderate-certainty that the effect may be similar at 12 months (MD -0.37 kg, 95% CI -0.86 to 0.11; 17 studies, 1463 participants; I2 = 0%), although the estimates are too imprecise to assess long-term benefit. There was mixed evidence of the effect of varenicline on weight, with high-certainty evidence that weight change was very modestly lower at the end of treatment (MD -0.23 kg, 95% CI -0.53 to 0.06; 14 studies, 2566 participants; I2 = 32%); a low-certainty estimate gave an imprecise estimate of higher weight at 12 months (MD 1.05 kg, 95% CI -0.58 to 2.69; 3 studies, 237 participants; I2 = 0%). Authors' conclusions: Overall, there is no intervention for which there is moderate certainty of a clinically useful effect on long-term weight gain. There is also no moderate- or high-certainty evidence that interventions designed to limit weight gain reduce the chances of people achieving abstinence from smoking.

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... Leisure-time physical activity (LTPA) has been shown to inhibit weight gain in general 14 . Evidence whether LTPA could impact post-cessation weight gain has been inconsistent 15 . It has been suggested that exercise may prevent weight gain in the long run 15 . ...
... Evidence whether LTPA could impact post-cessation weight gain has been inconsistent 15 . It has been suggested that exercise may prevent weight gain in the long run 15 . Less is known about the impact of LTPA on post-cessation change in abdominal obesity. ...
... Interaction was considered if p<0. 15. As there was no sex#smoking-interaction (p=0.375) ...
Preprint
BACKGROUND: This follow-up study investigated the associations of smoking status and leisure-time physical activity (LTPA) with weight circumference (WC) change. METHODS: In the FinnTwin16 cohort, 3,431 twins (47% men) reported smoking status, LTPA, and WC in early adulthood and 10 years later. Regression models were conducted to investigate associations of smoking status and of LTPA change (metabolic equivalent tasks [MET]-h/week) with WC change (cm) during the follow-up. Within-pair associations were analyzed using linear mixed fixed-effect regression among 800 same-sexed (409 identical) pairs. RESULTS: During the 10-year follow-up, 40% (n=454) quit smoking. Among those who quit smoking, the mean WC increase was 7.4 cm (SD 8.2) and the mean LTPA decrease was -0.02 MET-h/week (SD 35.8). Compared to individuals continuing daily smoking, only quitters who smoked daily at baseline (β 1.87; 95% CI 0.68, 3.06) increased their WC. This association was not robust after shared familial influences were controlled for. Each additional MET-h/week lowered the risk for WC increase among individuals who smoked occasionally (β -0.054; -0,08, -0.003), quitters who smoked daily (β -0.05; -0.06, -0.02) and those who had never smoked (β -0.04; -0.05, -0.03). In the analyses among identical twin pairs, LTPA was associated with less WC increase among those who quit occasional smoking or had never smoked. For quitters from daily smoking, this association approached significance, but no association remained for those continuing smoking. CONCLUSIONS: Smoking cessation seems to be associated with WC increase, but familial confounding is involved in this process. LTPA may inhibit post-cessation WC increase.
... Moreover, the data are conflicting, with in vivo studies suggesting weight loss effects, but in vitro studies do not support this claim Thus, the authors underlined the need for further investigation to determine the impact of ENDS on weight control [16]. Another review by Hartmann-Boyce et al [17] found 2 ENDS studies, 1 involving ENDS as an adjunct to nicotine replacement therapy and the other comparing them to varenicline, both with wide CIs at all measurement time points. The CIs of weight change (kg) at the end of the treatment and 12 months encompassed both clinically significant weight loss and weight gain [17]. ...
... Another review by Hartmann-Boyce et al [17] found 2 ENDS studies, 1 involving ENDS as an adjunct to nicotine replacement therapy and the other comparing them to varenicline, both with wide CIs at all measurement time points. The CIs of weight change (kg) at the end of the treatment and 12 months encompassed both clinically significant weight loss and weight gain [17]. Therefore, the authors stated that "data are needed on whether using e-cigarettes to quit smoking affects post-cessation weight change" [17]. ...
... The CIs of weight change (kg) at the end of the treatment and 12 months encompassed both clinically significant weight loss and weight gain [17]. Therefore, the authors stated that "data are needed on whether using e-cigarettes to quit smoking affects post-cessation weight change" [17]. ...
Article
Background Weight gain following smoking cessation is a well-documented concern, often attributed to the absence of nicotine’s metabolic influence. The adoption of Electronic Nicotine Delivery Systems (ENDS) has been used to achieve smoking cessation, with claims of aiding weight control. However, existing reviews present conflicting conclusions on ENDS’ impact on weight status, necessitating a rigorous evaluation. Objective We aim to conduct a systematic review with meta-analysis to assess the actual impact of ENDS on weight status in individuals who have ceased or reduced conventional smoking. The primary goal is to provide clinicians with evidence-based insights into the potential effects of ENDS use as a smoking substitute on weight control. Methods Adhering to PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines, our systematic review will analyze randomized and nonrandomized controlled trials, clinical trials (quasi-experimental), and prospective or retrospective cohort studies on the weight status effects of ENDS among individuals who have either quit or reduced smoking. Searches will include PubMed, Scopus, and Cochrane Library, covering the period from 2010 to January 2024. A gray literature search and supplementary searches will be performed. Data will be extracted independently by 2 reviewers and quality assessments will be conducted concurrently. Quality assessments will use Joanna Briggs Institute tools, 2020 version, along with bias assessments for internal validity and reporting bias based on the Catalogue of Bias. The included studies will be examined for any internal data reporting discrepancies by using Puljak’s checklist. Meta-analysis and subgroup analyses (ie, general ENDS usage, ENDS use coupled with a reduction in smoking exceeding 50%, and exclusive ENDS use for achieving smoking cessation) are planned. Certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. Results The protocol has been registered in PROSPERO (CRD42023494974) and the entire systematic review is expected to be completed by April 2024. The main goal of this review is to retrieve all current human research studies investigating the influence of ENDS on weight management among individuals who have quit or reduced smoking. Furthermore, the review will assess the quality of these studies and examine potential biases to identify the most dependable evidence available. Dissemination strategies will include traditional journal publications, social media announcements, and a white paper. The latter, available for download and distributed at conferences, aims to reach a broad audience, including clinicians and ENDS users. Conclusions The review will address the importance of informing health care professionals and patients about the current and robust evidence regarding the effects of transitioning to ENDS for smoking cessation on weight status. Trial Registration PROSPERO CRD42023494974; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=494974 International Registered Report Identifier (IRRID) PRR1-10.2196/56324
... Among the general population, there is evidence showing greater smoking cessation rates when smoking cessation treatments also provide weight management (García-Fernández et al., 2023;Hartmann-Boyce et al., 2021). However, few studies have evaluated the effectiveness of interventions for both quitting smoking and weight control for individuals with overweight or obesity (Heggen et al., 2016(Heggen et al., , 2017Hurt et al., 2017;Love et al., 2011;Svendsen et al., 2021;White et al., 2019;Wilcox et al., 2010). ...
... The primary outcome variables were: (1) treatment completion (i.e., participants who started the treatment and completed the EOT assessment); (2) smoking abstinence outcomes at EOT and FU (i.e., 1-, 3-, 6-, and 12-month), in terms of 7-day point-prevalence abstinence rates (i.e., percentage of participants who attained abstinence, "not even a puff", for a minimum of seven days prior to assessment), prolonged abstinence rates (i.e., percentage of participants who attained abstinence, "not even a puff", after a grace period of 15 days after the target quit date), and duration of continuous abstinence (i.e., number of consecutive days without smoking, "not even a puff", since participants successfully quit) ; (3) weight change in terms of body weight variation from baseline to EOT and 1-, 3-, 6-, and 12-month FU in those who achieved prolonged abstinence at these time points (Hartmann-Boyce et al., 2021). ...
... The overall smoking abstinence rates at EOT were 78.33% in the CBT + CM group and 61.67% in the CBT group, which are high compared to those reported for smoking cessation interventions with weight management (García-Fernández et al., 2023;Hartmann-Boyce et al., 2021) and to those from studies for quitting smoking among individuals with overweight or obesity (Heggen et al., 2016;White et al., 2019;Wilcox et al., 2010;71%, 25.9%, and 48.1%, respectively). There are at least three rationales that account for such high cessation rates. ...
Article
Full-text available
Background: Interventions for quitting smoking and weight control among individuals with excess weight are scarce. Our study evaluated the effectiveness of cognitive behavioral therapy (CBT) plus contingency management (CM) in this population, and examined whether CM for smoking cessation improved CBT treatment outcomes at end of treatment (EOT) and at 1-, 3-, 6-, and 12-month follow-ups (FU). Methods: In an 8-week randomized clinical trial, 120 adults who smoke with overweight or obesity (54.16% females; MBMI = 31.75 ± 4.31) were randomly assigned to CBT for both quitting smoking and weight control (n = 60) or the same treatment plus CM for smoking cessation (n = 60). Outcome variables were compared (i.e., treatment completion, smoking abstinence, weight change and secondary outcomes). Results: At EOT, the CBT + CM group achieved 78.33% 7-day point-prevalence abstinence rates compared to 61.67% in the CBT group (p = .073), and rates declined over time (12-month FU: 18% vs 12%). Participants who attained abstinence weighed more compared to baseline at EOT (Mkg = 1.07; SD = 1.88) and over time (12- month FU: Mkg = 4.19; SD = 4.31). No differences were found between the two groups in outcome variables. Conclusions: Both interventions were effective in promoting abstinence and reducing tobacco use over time. Combining CBT with CM for smoking cessation did not improve treatment outcomes in individuals with overweight or obesity compared to CBT only. Future studies should evaluate whether implementing CM for weight maintenance helps control post-cessation weight gain in this population.
... 12 Useful countermeasures against post-cessation weight gain are not established yet but needed. 13 Using the weight loss properties of glucagon-like peptide-1 (GLP-1) analogues might be a new strategy to address this issue, especially as GLP-1 analogues may also play a role in reward regulation and in the pathophysiology of addiction. [14][15][16] A pilot trial (n = 84) using exenatide for smoking cessation showed promising results with increased abstinence rates after six weeks compared to placebo (46.3% versus 26.8%) and less post-cessation weight gain. ...
... This is in line with previous results of similar interventions with abstinence rates of around 30% at best after one year since trying to quit smoking. [23][24][25] As a first requirement for long-term abstinence, short-term abstinence needs to be reached and typically several cessation attempts are [13,27] 18 [13,25] 19 [13,28] Smoking status ...
... This is in line with previous results of similar interventions with abstinence rates of around 30% at best after one year since trying to quit smoking. [23][24][25] As a first requirement for long-term abstinence, short-term abstinence needs to be reached and typically several cessation attempts are [13,27] 18 [13,25] 19 [13,28] Smoking status ...
Article
Full-text available
Background Smoking cessation is challenging, despite making use of established smoking cessation therapies. Preclinical studies and one clinical pilot study suggest the antidiabetic drug glucagon-like peptide-1 (GLP-1) analogue to modulate addictive behaviours and nicotine craving. Previously, we reported the short-term results of a randomised, double-blind, placebo-controlled trial. Herein we report long-term abstinence rates and weight developments after 24 and 52 weeks. Methods This single-centre, randomised, double-blind, placebo-controlled, parallel group trial was done at the University Hospital Basel in Switzerland. We randomly assigned (1:1) individuals with at least a moderate nicotine dependence willing to quit smoking to either a 12-week treatment with dulaglutide 1.5 mg or placebo subcutaneously once weekly in addition to standard of care smoking cessation therapy (varenicline 2 mg/day and behavioural counselling). After 12 weeks, dulaglutide or placebo injections were discontinued and the participants were followed up at week 24 and 52. The primary outcome of self-reported and biochemically confirmed point prevalence abstinence rate, and secondary outcome of secondary outcome of weight change were assessed at weeks 24 and 52. All participants who received one dose of the study drug were included in the intention to treat set and participants who received at least 10/12 doses of the study drug formed the per protocol set. The trial was registered at ClinicalTrials.gov, NCT03204396. Findings Of the 255 participants who were randomly assigned between June 22, 2017 and December 3, 2020, 63% (80/127) (dulaglutide group) and 65% (83/128) (placebo group) were abstinent after 12 weeks. These abstinence rates declined to 43% (54/127) and 41% (52/128), respectively, after 24 weeks and to 32% (41/127) and 32% (41/128), respectively, after 52 weeks. Post-cessation weight gain was prevented in the dulaglutide group (−1.0 kg, standard deviation [SD] 2.7) as opposed to the placebo group (+1.9 kg, SD 2.4) after 12 weeks. However, at week 24, increases in weight from baseline were observed in both groups (median, interquartile range [IQR]: dulaglutide: +1.5 kg, [−0.4, 4.1], placebo: +3.0 kg, [0.6, 4.6], baseline-adjusted difference in weight change −1.0 kg (97.5% CI [−2.16, 0.16])), and at week 52 the groups showed similar weight gain (median, IQR: dulaglutide: +2.8 kg [−0.4, 4.7], placebo: +3.1 kg [−0.4, 6.0], baseline-adjusted difference in weight change: −0.35 kg (95% CI [−1.72, 1.01])). In the follow-up period (week 12 to week 52) 51 (51%) and 48 (48%) treatment-unrelated adverse events were recorded in the dulaglutide and the placebo group, respectively. No treatment-related serious adverse events or deaths occurred. Interpretation Dulaglutide does not improve long-term smoking abstinence, but has potential to counteract weight gain after quitting. However, 3 months of treatment did not have a sustained beneficial effect on weight at 1 year. As post-cessation weight gain is highest in the first year after quitting smoking, future studies should consider a longer treatment duration with a GLP-1 analogue in abstinent individuals. Funding Swiss National Science Foundation, the 10.13039/501100005688Gottfried and Julia Bangerter-Rhyner Foundation, the 10.13039/501100016071Goldschmidt-Jacobson Foundation, the Hemmi-Foundation, the 10.13039/100008375University of Basel, the Swiss Academy of Medical Sciences.
... Behavioural support interventions offer advice and counselling that focuses on stopping smoking and/ or providing information about stopping smoking, either in a group or one-to-one setting (Hartmann-Boyce et al, 2021). Telephone counselling, quit lines and, more recently, mobile phone apps are used to support those who are considering quitting, and those who have recently quit smoking (Crane et al, 2018;NICE, 2018). ...
... Telephone counselling, quit lines and, more recently, mobile phone apps are used to support those who are considering quitting, and those who have recently quit smoking (Crane et al, 2018;NICE, 2018). Behaviour support interventions can independently increase quit rates with the strongest benefits found when using any form of counselling (Hartmann-Boyce et al, 2021). ...
... Therefore, more high-quality trials are required in this area to better understand the role of mindfulness techniques in smoking cessation. There is insufficient evidence to suggest a possible beneficial role of smoking cessation and weight gain therapies in limiting post-cessation weight gain in people stopping smoking in the long term (Hartmann-Boyce et al, 2021) and also of exercise interventions aiming to increase cessation rates among smokers (Ussher et al, 2019). ...
Article
Full-text available
Despite a general decline in smoking in the UK, prevalence remains high in certain groups such as young adults, pregnant women, those who have a mental Illness and those from socio-economically disadvantaged backgrounds. These groups are also more likely to benefit from targeted smoking cessation interventions. Clinical contact between health professionals and patients who smoke creates an opportunity for offering cessation interventions and to reduce smoking-related harm. This article summarises evidence reported in high-quality systematic reviews on smoking cessation interventions that could be offered by health professionals coming in to contact with patients who smoke. The evidence presented here suggests that brief advice by a health professional is beneficial in achieving smoking cessation and so is intensive behavioural support, alone or in combination with pharmacotherapies (nicotine replacement therapies [NRTs], bupropion and varenicline). Pharmacotherapies are also effective individually in achieving smoking cessation; a combination of NRTs (oral or skin patch) can be particularly helpful among highly dependent smokers. Pharmacotherapies in combination with behavioural support delivered in healthcare settings are more effective than when used alone and delivered in community settings, respectively. Electronic cigarettes are also effective in achieving smoking cessation and are more effective than NRT.
... Despite post-cessation weight gain being associated with smoking relapse Salk et al., 2019), the impact of changes in smoking or other in-treatment behaviors (such as eating or exercising) on weight has not yet been studied. This area of research could enhance weight management methods within the context of quitting smoking, which is relevant considering the limited evidence found in previous meta-analysis of interventions aimed at controlling post-cessation weight gain Hartmann-Boyce et al., 2021). ...
... Individuals with a sedentary lifestyle, prior to quitting smoking, are at greater risk of postcessation weight gain (see e.g., Kmetova et al., 2014). A previous metaanalysis on interventions for preventing weight gain after smoking cessation (Hartmann-Boyce et al., 2021) concluded that exercise interventions did not significantly impact on weight at the end of treatment (EOT) but weight was reduced at 12 months. Moreover, smoking cessation is associated with a mean increase of 4-5 kg after 12 months of abstinence, and most weight gain occurs within the first three months after quitting (Aubin et al., 2012). ...
Article
Full-text available
Introduction: A more comprehensive understanding of the factors regarding weight control in individuals with overweight or obesity after quitting smoking is needed. The study aimed to analyze the changes of in-treatment variables during a smoking cessation intervention and examine their impact on weight. Methods: A total of 120 individuals who smoke with overweight or obesity (MBMI = 31.75 ± 4.31; 54.16 % female) participated in a cognitive-behavioral therapy for smoking cessation and weight control or the same treatment plus contingency management. Weight, smoking variables (cotinine and continuous abstinence), eating behaviors (appetite, grazing), exercise, and sleep were assessed weekly throughout the treatment. Results: More participants gained weight over time with reduced nicotine use or abstinence. There was a tendency during treatment to increase appetite and exercise time, while grazing episodes and sleeping hours remained stable. Higher baseline weight (p < .001), greater cotinine reduction (p = .021) and time (p = .009) were associated with greater weight gain, while more hours of exercise (p = .003), no appetite changes (p = .003) and diminished appetite (p < .001) were associated with less gain over the treatment. Both treatment conditions showed similar results in all in-treatment variables. Discussion: Individuals with overweight and obesity with higher baseline weight and higher baseline cotinine levels during smoking cessation interventions may require special attention to improve weight outcomes. Exercise and appetite regulation may be useful for mitigating weight gain in smoking cessation interventions for individuals with overweight or obesity.
... This interpretation is supported by the finding that among both persons of migrant origin and the general population, respondents with a high body mass index (bMI) were less likely to increase their smoking than those who were underweight/normal weight. People who stop smoking might gain some weight, which might discourage some smokers from attempting to quit [28]. using nicotine replacement therapy (nRT) might reduce weight after smoking cessation, although the long-term effects are inconclusive [28]. ...
... People who stop smoking might gain some weight, which might discourage some smokers from attempting to quit [28]. using nicotine replacement therapy (nRT) might reduce weight after smoking cessation, although the long-term effects are inconclusive [28]. based on this notion, persons of migrant origin with a bMI of at least 30 might benefit from using nRT in their attempts to quit. ...
Article
Full-text available
Aims: Prior studies have implied that smokers may have changed their smoking behaviour during the COVID-19 pandemic. However, little is known about changes in smoking behaviour and correlates of change due to the pandemic among persons of migrant origin compared with the general population. Methods: Population-based cross-sectional studies with comparable study protocols and measures, one focusing on persons of migrant origin living in Finland (n = 3587, response rate 60%) and the other on the general Finnish population (n = 3444, response rate 56%), were utilised. The outcome measure was self-reported change in smoking behaviour due to COVID-19 among current smokers. Explanatory factors included sociodemographic-, health-, and COVID-19-related factors. Multinomial logistic regression was used in the analyses. Results: Most of the current smokers reported no change in their smoking behaviour. In the adjusted model, younger age was positively associated with increased smoking, while region of origin (Russia, Africa, Asia, and Latin America) and worrying about getting infected with COVID-19 were associated with decreased smoking among persons of migrant origin. In the general population, younger age, female sex, being other than employed/student, increased loneliness, and decreased contact with close ones were associated with increased smoking, while reduced working capacity and worries that someone close to the respondent will be infected with COVID-19 were associated with decreased smoking. Conclusions: The findings of this study contribute to better identification of at-risk populations in future crises situations. This will allow for more efficient targeting and tailoring of health promotion services, including smoking cessation.
... 10,11 It is well known that smokers who make a serious attempt to quit smoking with pharmacological therapy gain less weight in the process. 12 Perhaps, those who gain weight and therefore do not attend the follow-ups visits do not follow the pharmacological treatments, nor do they follow the dietary advice or not are subjected to strict control of their weight evolution throughout the smoking cessation process. [12][13][14] Regarding the beliefs of why smokers believe that they are not capable of quitting, they have been indicated, addiction, habit, willpower and motivation, as causes of the inability to stop smoking. ...
... 12 Perhaps, those who gain weight and therefore do not attend the follow-ups visits do not follow the pharmacological treatments, nor do they follow the dietary advice or not are subjected to strict control of their weight evolution throughout the smoking cessation process. [12][13][14] Regarding the beliefs of why smokers believe that they are not capable of quitting, they have been indicated, addiction, habit, willpower and motivation, as causes of the inability to stop smoking. 10 The present work has several limitations: 1. ...
... Additionally, a meta-analysis of the effectiveness of multiple risk behavior interventions suggested that there is a concern that targeting both health outcomes may undermine quitting (Meader et al., 2017). An update of Farley et al. (2012) meta-analysis, current up to October 2020(Hartmann-Boyce et al., 2021, concluded that it is not clear which treatments work best to avoid gaining weight when stopping smoking, or how they affect smoking abstinence outcomes. Implications for research of this meta-analysis stressed that behavioral programmes are the mainstay for weight management and further studies are needed to clarify the evidence on whether they limit weight gain and impact on smoking abstinence (e.g., it was found that a personalized weight-management programme may reduce weight gain but a weight-management programme without personalized assessment, planning and feedback may not reduce weight gain, and may reduce the number of people who stop smoking). ...
... In line with previous meta-analysis Hartmann-Boyce et al., 2021;Spring et al., 2009) but in contrast with others (Meader et al., 2017) concluding that it may not be optimal to target smoking simultaneously with other risk behaviors, the present study found that there was no evidence to suggest that adding a weight management component worsened smoking cessation outcomes. In fact, it seems that adding a weight component to a smoking cessation intervention improves smoking cessation outcomes at EOT, but that such effect is short lived, and likely an artifact of increasing the intensity or attention provided to the individuals in treatment. ...
Article
I ntroduction The potential of weight gain after smoking cessation reduces the incentive to quit. This meta-analysis examines the efficacy of behavioral interventions for smoking cessation that also address post-cessation weight gain. Methods Medline, Web of Science, PsycINFO and the Cochrane Central Register of Controlled Trials were searched for randomized controlled trials on behavioral treatments targeting both health outcomes. Six separate meta-analyses were undertaken to assess treatment efficacy on smoking abstinence and weight outcomes at end of treatment (EOT), short-term, and long-term follow-up. Individual and treatment moderators were examined as well as methodological quality and publication bias of studies. Results A total of 28 studies were included in the meta-analysis. There was a statistically significant positive impact of treatments addressing both targets on smoking outcomes at EOT (RR = 1.279, 95% CI: 1.096, 1.492, p = .002), but not at follow-ups. Age impacted on EOT abstinence rates Q (1) = 4.960, p = .026) while increasing the number of sessions significantly improved EOT abstinence rates (p = .020). There was no statistically significant impact of these treatments on weight at EOT (Hedges’ g = -.015, 95% CI: -.164, .135, p = .849) or follow-ups (short term: Hedges’ g = .055, 95% CI: -.060, .170, p = .347; long term: Hedges’ g = -.320, 95% CI: -.965, .325, p = .331). There were minimal impacts of publication bias, mostly related to sample size, meaning studies including small sample sizes revealed larger effect sizes on abstinence at EOT. Discussion Addressing post-cessation weight management in treatments for smoking cessation significantly enhances tobacco abstinence at EOT though it was not found to have a lasting impact after treatment.
... Furthermore, longer courses of NRT were not associated with reduced weight gain at 12 months and there was no significant dose dependent difference in weight gain at the end of treatment or at 12 months [148]. The cited review was updated recently and concluded that there was moderate-certainty evidence that NRT reduced weight at the end of treatment and that the effect may be similar at 12 months [149]. Another network-meta-analysis reported that nicotine patches in combination with other medications, and especially fluoxetine, had superior efficacy in controlling PSCWG than placebo treatment, and that nicotine patch 14 mg plus fluoxetine 40 mg treatment might be one of the best options for patients with obesity and nicotine dependence. ...
... This report suggested that, of all three licensed medications, bupropion has the largest effect on weight gain. However, there is no strong evidence that bupropion reduces weight gain in the long-term [148,149]. Bupropion increases levels of dopamine and norepinephrine in the brain, similar to the effects of nicotine, providing a potential mechanism of weight control [9], decreases the nicotine-reward threshold and attenuates the effect of food reward [157]. Bupropion is safe for people with DM and, considering its ability to reduce PSCWG, it could therefore be proposed as a treatment of choice in obese patients with DM [101]. ...
Article
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Smokers with diabetes mellitus substantially lower their risks of microvascular and macrovascular diabetic complications, in particular cardiovascular disease, by quitting smoking. However, subsequent post-smoking-cessation weight gain may attenuate some of the beneficial effects of smoking cessation and discourage attempts to quit. Weight gain can temporarily exacerbate diabetes and deteriorate glycemic control and metabolic profile. The molecular mechanisms by which quitting smoking leads to weight gain are largely associated with the removal of nicotine’s effects on the central nervous system. This review addresses mechanisms of post-smoking-cessation weight gain, by reviewing the effects of nicotine on appetite, food intake, eating behaviour, energy expenditure, fat oxidation and appetite-regulating peptides. We also highlight correlations between post-cessation weight gain and risk of type 2 diabetes, consequences of weight gain in people with type 2 diabetes and the role of pharmacotherapies, which combine treatment of nicotine addiction and promotion of weight control.
... However, the association between smoking and weight loss remains debatable 5,6 . Nonetheless, the most widely accepted aspect of the relationship between body weight and smoking, with substantial evidence, is that quitting smoking leads to weight gain, at least temporarily 2,[7][8][9] . ...
... It is also important to promote healthy nutrition changes in the dietary habits since smoking cessation may lead to an increased intake of high-calorie foods, resulting in bodyweight gain [71]. In this sense, evidence shows that weight gain can lead to poor diabetes control for T2DM smokers [68,72], with women being particularly at risk of gaining weight and, therefore, perceiving more barriers to stop smoking [73]. ...
... However, a significant weight reduction was observed at 12 months post intervention [80]. Subsequent updates to the review reaffirmed these findings, indicating low certainty regarding the effectiveness of exercise interventions in achieving minimal or no weight reduction compared to standard care at the end of the treatment, though weight reduction was noticeable after 12 months [90]. Thus far, the benefits of physical activity in ameliorating PSCWG are inconclusive. ...
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Background: Smoking cessation is crucial for reducing complications of type 2 diabetes mellitus (T2DM), but associated weight gain can worsen glycemic control, discouraging quitting attempts. Varenicline, a partial agonist of α4β2 nicotinic receptors, aids smoking cessation. This study examines the effects of varenicline on body weight and metabolic parameters in patients with T2DM and prediabetes. Methods: Fifty-three patients were enrolled, of which 32 successfully quit smoking after a three-month course of varenicline and were examined after an additional month with no medication. Measurements taken at baseline, 2.5 months, and 4 months included body weight, blood pressure, resting metabolic rate (RMR), glycated hemoglobin (HbA1c), fasting glucose, blood lipids, C-reactive protein (CRP), appetite-related hormones, and physical activity. Results: Post-treatment, there were no significant changes in body weight, blood pressure, RMR, or glycemic control. Total (CHOL) and low-density lipoprotein (LDL-C) cholesterol decreased significantly at 4 months of the study (from 168 to 156 mg/dL, p = 0.013, and from 96 to 83 mg/dL, p = 0.013, respectively). Leptin levels increased (from 11 to 13.8 ng/dL, p = 0.004), as did glucagon-like peptide-1 (GLP-1) levels (from 39.6 to 45.8 pM, p = 0.016) at 4 months of follow-up. The percentage of participants who reported moderate-intensity activity increased from 28% to 56%, while those reporting high-intensity activity increased from 19% to 22%, respectively (p = 0.039). Conclusions: Our study showed that smoking cessation with varenicline in smokers with T2DM and prediabetes led to significant improvements in lipid profile, significant increase in plasma leptin and GLP-1 levels, and increased physical activity, without significant weight gain. Thus, smoking cessation without weight gain or deteriorated glycemic control is feasible for these smokers, with added benefits to lipid profiles, GLP-1 regulation, and physical activity.
... Finally, smoking cessation itself has a risk of obesity, and weight control program should be applied in combination with smoking cessation. Many harmful health risks by smoking would reduce by smoking cessation [3][4][5], and effective weight control program for quitters should be prepared [6]. ...
... Our association can be explained by the progressive loss of taste that occurs as a direct consequence of cigarette use, contributing to a sensory preference for diets rich in saturated fats and alcohol, with lower consumption of carbohydrates and proteins [44,49,50]. In addition, there is evidence that an LCD can result in more severe symptoms of nicotine withdrawal [51]. ...
Article
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In the field of nutrition, both low-carbohydrate (LCD) and low-fat (LFD) diets were initially intended for specific subgroups but are now being embraced by the broader population for various purposes, including aesthetics and overall health. This study aims to assess sociodemographic, health, and lifestyle factors influencing diet choices among public servants in the ELSA-Brasil cohort. Diets were classified as LCD or LFD based on the Brazilian Diabetes Society (<45%) and WHO guidelines (<30%) respectively. A total of 11,294 participants were evaluated (45.3% men; 54.7% women) with a mean age of 52 ± 0.08 years. Having overweight, altered waist circumference, and a history of smoking confers higher chances of adopting an LCD compared to the usual diet, while being over 52 years, non-White race/skin color, in a lower income stratum, and having diagnosis of hypertension and/or diagnosis of diabetes mellitus decrease these chances. Regarding LFDs, belonging to the non-White race/skin color, being over 52 years old, being divorced, and practicing low physical activity decrease the chances of following such a diet compared to the usual diet. In conclusion, factors like age, socioeconomic status, health, and physical activity levels can be the key to understanding why individuals choose restrictive diets beyond clinical advice.
... In support, recent meta-analyses demonstrate that concurrent smoking cessation and behavioural weight management interventions may reduce the associated weight gain and increase rates of smoking abstinence [55,56]. Additionally, addressing a greater number of 'risky' behaviours in smokers through behavioural change interventions has been linked to greater cessation success [57,58]. ...
Article
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Background and aims Smokers typically have a lower body mass index (BMI) than non‐smokers, while smoking cessation is associated with weight gain. In pre‐clinical research, nicotine in tobacco smoking suppresses appetite and influences subsequent eating behaviour; however, this relationship is unclear in humans. This study measured the associations of smoking with different eating and dietary behaviours. Design A cross‐sectional analysis of data from health assessments conducted between 2004 and 2022. Setting An independent healthcare‐based charity within the United Kingdom. Participants A total of 80 296 men and women (mean ± standard deviation [SD]: age, 43.0 ± 10.4 years; BMI, 25.7 ± 4.2 kg/m ² ; 62.5% male) stratified into two groups based on their status as a smoker ( n = 6042; 7.5%) or non‐smoker ( n = 74 254; 92.5%). Measurements Smoking status (self‐report) was the main exposure, while the primary outcomes were selected eating and dietary behaviours. Age, sex and socioeconomic status (index of multiple deprivation [IMD]) were included as covariates and interaction terms, while moderate‐to‐vigorous exercise and sleep quality were included as covariates only. Findings Smokers had lower odds of snacking between meals and eating food as a reward or out of boredom versus non‐smokers (all odds ratio [OR] ≤ 0.82; P < 0.001). Furthermore, smokers had higher odds of skipping meals, going more than 3 h without food, adding salt and sugar to their food, overeating and finding it hard to leave something on their plate versus non‐smokers (all OR ≥ 1.06; P ≤ 0.030). Additionally, compared with non‐smokers, smoking was associated with eating fried food more times per week (rate ratio [RR] = 1.08; P < 0.001), eating fewer meals per day, eating sweet foods between meals and eating dessert on fewer days per week (all RR ≤ 0.93; P < 0.001). Several of these relationships were modified by age, sex and IMD. Conclusions Smoking appears to be associated with eating and dietary behaviours consistent with inhibited food intake, low diet quality and altered food preference. Several of these relationships are moderated by age, sex and socioeconomic status.
... While cigarette smoking is associated with lower weight (which could be considered a benefit), there is much less evidence that this is mediated by nicotine alone as shown by weight gain following smoking cessation even when NRT is used. 13 Perhaps the only evidence for a health benefit is for ulcerative colitis, a painful inflammatory disease. Here trial evidence suggests that transdermal nicotine, not alone but in combination with standard treatment, can improve outcomes. ...
... As such, smoking cessation programs may provide an opportunity to address these multiple modifiable health risk behaviours through brief intervention approaches. However, there is a risk that the addition of generic brief interventions focused on weight management might reduce smoking cessation rates by about 40% while being ineffective [24]. The challenge of addressing multiple health behaviours in primary care settings is not well described. ...
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Background Post-smoking-cessation weight gain can be a major barrier to quitting smoking; however, adding behavior change interventions for physical activity (PA) and diet may adversely affect smoking cessation outcomes. The “Picking up the PACE (Promoting and Accelerating Change through Empowerment)” study assessed change in PA, fruit/vegetable consumption, and smoking cessation by providing a clinical decision support system for healthcare providers to utilize at the intake appointment, and found no significant change in PA, fruits/vegetable consumption, or smoking cessation. The objective of this qualitative study was to explore the factors affecting the implementation of the intervention and contextualize the quantitative results. Methods Twenty-five semi-structured interviews were conducted with healthcare providers, using questions based on the National Implementation Research Network’s Hexagon Tool. The data were analyzed using the framework’s standard analysis approach. Results Most healthcare providers reported a need to address PA and fruit/vegetable consumption in patients trying to quit smoking, and several acknowledged that the intervention was a good fit since exercise and diet could improve smoking cessation outcomes. However, many healthcare providers mentioned the need to explain the fit to the patients. Social determinants of health (e.g., low income, food insecurity) were brought up as barriers to the implementation of the intervention by a majority of healthcare providers. Most healthcare providers recognized training as a facilitator to the implementation, but time was mentioned as a barrier by many of healthcare providers. Majority of healthcare providers mentioned allied health professionals (e.g., dieticians, physiotherapists) supported the implementation of the PACE intervention. However, most healthcare providers reported a need for individualized approach and adaptation of the intervention based on the patients’ needs when implementing the intervention. The COVID-19 pandemic was found to impact the implementation of the PACE intervention based on the Hexagon Tool indicators. Conclusion There appears to be a need to utilize a flexible approach when addressing PA and fruit/vegetable consumption within a smoking cessation program, based on the context of clinic, the patients’ it is serving, and their life circumstances. Healthcare providers need support and external resources to implement this particular intervention. Name of the registry Clinicaltrials.gov. Trial registration number NCT04223336. Date of registration 7 January 2020 Retrospectively registered. URL of trial registry record https://classic.clinicaltrials.gov/ct2/show/NCT04223336.
... It has been found that smoking before and during pregnancy increases two times the risk of developing obesity during childhood (28). Moreover, gaining weight after smoking cessation is a very common phenomenon (30,31). The cause of gaining weight after quitting smoking is excessive calorie intake, decreased resting metabolism rate, decreased physical activity and increased lipoprotein lipase activity (32,33). ...
Article
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In past decades the prevalence of overweight and obesity had grown rapidly. There are numerous factors contributing to this unfavorable change in people’s health. This review article investigates the environmental factors which may play a role in the prevalence of overweight and obesity and additionally the novel factors which appeared after the beginning of the COVID-19 pandemic, which caused the increase in BMI during the lockdown period. Most of the studies reveal that the COVID-19 pandemic and lockdown contributed to the growth of BMI in numerous countries and, eventually the prevalence of overweight and obesity increased. Studies suggest that the physical activity was decreased while sleep time and screen time were increased and the amount of food consumed increased, additionally more processed food with long shelf life was consumed. The diverse environmental factors may have an impact on obesity and overweight development taking into account policy and local school policy issues, socioeconomic status, lifestyle including physical activity, diet habits, and amongst others, more trivial causes such as uninteresting neighborhoods, lack of sense of security outside the place of residence or a long distance from shops. Still, this is the object of debate if air pollution is an environmental risk factor influencing the unfavorable trends towards increasing body weight.
... Exercise can help counteract weight gain and promote a healthier lifestyle, which can further support smoking cessation efforts. 16 In addition, regular exercise can help build self-efficacy, or the belief in one's ability to succeed in quitting smoking can support the maintenance of long-term abstinence. 17 Several forms of exercise have been evaluated as a complementary treatment for smoking cessation, including yoga, 18 aerobic exercise, 19 and resistance exercise. ...
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This study examined a supervised moderate-intensity aerobic exercise programme’s effectiveness in regulating the Tobacco Withdrawal Symptoms (TWS) during temporary abstinence. This was a single group, pre and post-quasi intervention study. Thirty daily smokers participated in an 8-week supervised moderate-intensity aerobic exercise programme. We assessed the TWS, smoking urge, mood and stress-pleasure related hormonal variables after the aerobic exercise intervention. The measurements were conducted after overnight abstinence at baseline, post-intervention (at week-8) and post-detraining (at week-10). TWS components, smoking urge and mood were found to improve. For hormonal variables, cortisol and beta-endorphin except adrenaline showed insignificant changes at post-intervention and de-training. The findings suggest moderate-intensity exercise might help in reducing withdrawal symptoms and its adverse effects. Thus, exercise is an effective adjunct treatment in a smoking cessation programme.
... That is related to nicotine withdrawal that can lead to a decrease in metabolic rate and an increase anxiety levels, among other factors (Audrain-Mcgovern & Benowitz, 2011). A meta-analysis found that there is currently no intervention with a moderate level of certainty that effectively prevents long-term weight gain, nor is there evidence that weight gain prevention interventions improve smoking cessation rates (Hartmann-Boyce et al., 2021). Based on recent guideline, the recommended approach for treating obesity in smokers must prioritize smoking cessation as the primary focus. ...
Article
Objectives To evaluate the association between nutritional status in early adulthood and the burden of noncommunicable diseases (NCDs); To evaluate the influence of sociodemographic factors and lifestyle on the outcomes of BMI kg/m2 ≤24.9, ≥25.0, and ≥30.0; to estimate the population attributable fraction (PAF) to BMI elevated at 25 years old in the burden of NCDs in American adults. Methods We used data from 15 721 American adults participating in the National Health and Nutrition Examination Survey from 2007 to 2018. The Hazard Ratio (HR), Incidence Rate Ratio (IRR), and 95% confidence intervals (CI) were estimated in the proportional risk regression models of Cox (entire population) and Poisson (restricted to non-patients), respectively. The proportionality of the risk between the burden of NCDs and BMI at 25 years old was drawn by the Kaplan–Meier curve, and the PAF was calculated. All analyses were adjusted taking into account the sample weights. Results Health disparities (sex, age, race/ethnicity, education, poverty index, and education level), and lifestyle (physical activity, smoking, and alcohol consumption) influenced the current nutritional status. Cumulative survival in overweight and obese groups decreased considerably over time (p < .0001). Being overweight and obese in adulthood may increase the risk of early NCDs (HR: 1.68, 95% CI: 1.54–1.84 and HR: 2.87, 95% CI: 2.56–3.21, respectively). About 22.72% (95% CI: 19.99–25.36, p < .001) of the burden NCDs could have been avoided if overweight at age 25 had been prevented. Conclusions Monitoring weight change from young adulthood can provide a sensitive and useful clinical measure for early detection of adverse trends in NCDs risk.
... Specifically, the most recent Cochrane review indicates that while certain medications (e.g., phenylpropanolamine, naltrexone, dexfenfluramine, bupropion, fluoxetine) may be helpful in the short-term after quitting smoking, these medications are associated with potential side effects and seem to have limited efficacy in the long-term. 11 Similarly, there have also been multiple studies investigating behavioral intervention packages (e.g., exercise, diet modification, mindful eating, cognitive behavioral therapy) for reducing weight gain after quitting smoking. 12 However, meta-analysis has shown that these behavioral weight management intervention packages did not lead to a significant improvement in post-cessation weight gain. ...
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Background Smoking cessation is associated with weight gain, and the risk of weight gain is a common deterrent to quitting smoking. Thus, the identification of strategies for reducing post‐smoking cessation weight gain is critical. Objective Conduct secondary analysis of data from the Fit & Quit trial to determine if greater frequency of self‐weighing is associated with less weight gain in the context of smoking cessation. Methods Participants ( N = 305) were randomized to one of three 2‐month weight interventions (i.e., Stability, Loss, Bibliotherapy), followed by a smoking cessation intervention. Stability and Loss conditions received different types of self‐weighing feedback. All participants received e‐scales at baseline, to capture daily self‐weighing data over 12 months. General linear models were applied to test the main objective. Results Frequency of self‐weighing was (mean ± SD) 2.67 ± 1.84 days/week. The Stability condition had significantly higher self‐weighing frequency (3.18 ± 1.72 days/week) compared to the Loss (2.51 ± 1.99 days/week) and the Bibliotherapy conditions (2.22 ± 1.63 days/week). Adjusting for baseline weight and treatment condition, self‐weighing 3–4 days/week was associated with weight stability (−0.77 kg, 95% CI: −2.2946, 0.7474, p = 0.3175), and self‐weighing 5 or more days/week was associated with 2.26 kg weight loss (95% CI: −3.9249, −0.5953, p = 0.0080). Conclusions Self‐weighing may serve as a useful tool for weight gain prevention after smoking cessation. Feedback received about self‐weighing behaviors and weight trajectory (similar to the feedback Stability participants received) might enhance adherence.
... According to one systematic review and meta-analysis, individuals who received a variety of combined smoking and weight control treatments simultaneously were more likely to be abstinent from smoking and see reductions in weight, although effect sizes related to weight loss were small, and effects were no longer significant after six months [12]. A more recent review focused on post-cessation weight management studies [13] concluded, "there is no intervention for which there is moderate certainty of a clinically useful effect on longterm weight gain," although there was some indication that exercise interventions may reduce weight gain. Thus, there is a need to identify and test interventions that may preclude post-cessation weight gain and promote long-term cessation. ...
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Background/Objectives Weight gain is a barrier to smoking cessation. Previous interventions targeting weight gain while quitting smoking have largely been unsuccessful. The current study aimed to assess the efficacy of weight stability and weight loss interventions compared to a low-intensity, self-guided bibliotherapy weight management group. Subjects/Methods A randomized controlled trial with 12-month follow-up from 2018 to 2022 was conducted with participants (N = 305) who reported smoking at least five cigarettes per day for the last year and interest in quitting initially recruited from the Memphis, TN, USA area. Recruitment was expanded nationally with the onset of the COVID-19 pandemic. Subsequently, 276 completed 12-month follow-up. Interventions/Methods The Bibliotherapy group was provided a weight management book. Both the Stability and Loss groups met via telephone for eight weeks to learn strategies for maintaining/losing weight, respectively. All three groups then received the same six-week smoking cessation intervention, with six months of varenicline provided. Results Individuals in the Loss group lost more weight (−2.01 kg, SE = 1.58) than individuals in the Bibliotherapy group (+1.08 kg, SE = 1.49, p = 0.0004), while the Stability group (−0.30 kg, SE = 1.56) was not significantly different from the Bibliotherapy group (p = 0.17). Those in the Stability group did not gain a significant amount of weight. Participants in the Loss group did not gain back all weight lost after smoking cessation and ended the study approximately 2.01 kg lower than baseline. The Bibliotherapy group did not gain the amount of weight expected after cessation. There were no significant differences between groups related to self-reported smoking cessation at each time point except at eight-month follow-up (p = 0.005). Conclusions and relevance Results indicated the Stability and the Loss interventions were effective for preventing post-smoking cessation weight gain, with the Loss group having the benefit of sustained weight loss. These interventions may be helpful to implement to combat weight gain and potentially facilitate smoking cessation. Trial Registration The trial is registered on clinicaltrials.gov (NCT03156660).
... Therefore, participation in a physical exercise program is helpful in sustaining smoking abstinence. 5 Excessive alcohol use is also a trigger for smoking, and those who stop smoking are more likely to consume less alcohol than those who continue to smoke. 6 Hence, it is important to monitor alcohol use after cessation and intervene appropriately. ...
... Metanalysis concluded that pharmacological interventions limited the short-term weight gain during smoking cessation. However, there are no clinically effective interventions to restrict long-term weight gain currently (39). ...
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Background Smoking behavior differs between the sexes. Weight control is one of the main reasons leading to tobacco abuse in women but not in men. Studies on the predictive factors of cessation failure between sexes are scarce. This study is aim to investigate whether there are sex differences in the effect of weight gain on smoking cessation rate. Methods Participants in the smoking-cessation program at a Medical Center in Taiwan between 2018 and 2019 were included. Details of age, sex, comorbidities, depression screening, nicotine dependence, body weight, and cessation medications of the participants were collected. The participants were classified based on their sex, and multivariable logistic regression analyses were conducted. Multivariable logistic regression analyses were performed for sensitivity analysis after stratifying the participants according to their weight loss (weight loss ≥ 1.5 kg and weight loss ≥ 3.0 kg). Results A total of 1,475 participants were included. The body-weight gain in women was associated with failed abstinence (adjusted odds ratio (OR): 3.10, 95% CI: 1.10–9.04). In contrast, body-weight gain in men was associated with successful 6-month prolonged abstinence (adjusted OR: 0.77, 95% CI: 0.61–0.98). The adjusted ORs for any body-weight loss, body-weight loss ≥1.5 kg, and body-weight loss ≥3.0 kg were 0.28 (95% CI: 0.09–0.88), 0.14 (95% CI: 0.03–0.55), and 0.03 (95% CI: 0.01–0.42), respectively. Conclusion Body-weight gain in women during a hospital-based smoking-cessation program is associated with abstinence failure. Further multicenter studies, including participants of different races and cultural backgrounds, are warranted.
... To our knowledge, no study has evaluated a specific CBT for weight gain prevention while quitting smoking that comprehensively targeted post-cessation weight concerns, diet, activity and disordered eating among smokers with overweight or obesity (Hartmann-Boyce et al., 2021), which are key factors in the obesity field (Durrer Schutz et al., 2019;Paixao et al., 2020). In addition, no study to date has explored the effect of CM for smoking cessation among smokers with overweight or obesity. ...
Article
Background Post-cessation weight gain is a risk factor for relapse among quitters. The primary study aim was to evaluate, among smokers with overweight or obesity, the feasibility and acceptability of a cognitive-behavioral treatment (CBT) plus contingency management (CM) for quitting smoking and weight control. The secondary aim was to examine preliminary tobacco abstinence and weight change outcomes. Methods In an 8-week pilot randomized clinical trial, 41 participants (M age = 52.73, SD = 10.91, 56.1% females) with overweight or obesity (M BMI = 31.86, SD = 4.7) received a CBT for both quitting smoking and weight gain prevention (n = 24) or the same treatment plus CM (n = 17), consisting of providing incentives contingent upon smoking abstinence biochemically verified. Results Recruitment success rate was 80.39% (41/51), completion rate was 90.24% (37/41), and mean number of sessions attended (out of 15 possible) was 13.20 (SD = 3.1). Mean satisfaction rating for the treatment (1–10 likert-type scale with 10 being most satisfactory) was 9.73 (SD =.61). Preliminary efficacy data indicated that the CM group achieved higher abstinence rates compared with the CBT condition (100% vs. 58.33%, p =.007). Abstinent participants increased 1.25 kg (SD = 1.79) their baseline body weight at the end of treatment (p =.001). Conclusions Providing weight gain prevention strategies and CM within a smoking cessation treatment seems feasible and acceptable. Preliminary data indicated that including CM facilitates tobacco abstinence rates, nevertheless no advantage for CM was found for weight control.
... Withdrawal from nicotine not only increases the rewarding value of food but also elevates the threshold of the reward in the brain, which collectively lead to high energy-dense food consumption (25). A number of interventions such as a low-calorie diet, drug treatment, exercise, and nicotine replacement therapy have proved to be effective in lowering postcessation weight gain in the short term; however, it remains uncertain if there is an optimal intervention strategy to prevent long-term weight gain without undermining the chance of achieving abstinence (26). In the stratified analysis by postcessation weight gain among those who had ceased smoking, the risk reduction for total cancer was attenuated from 10% for participants with less than 10 kg of weight gain to 4% for those with 10 kg or more weight gain. ...
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Background It remains unknown how cancer risks vary by duration of smoking cessation and whether the benefit is attenuated by post-cessation weight gain. Methods We prospectively followed 198,565 persons from Nurses’ Health Study (NHS, 1978-2016), NHSII (1991-2017), and Health Professionals Follow-up Study (1988-2016) who were free of cancer at baseline. We used proportional hazard Cox models to compare cancer risk between current smokers and former smokers with different durations of smoking cessation and post-cessation weight gains. Results During 4,718,199 person-years of follow-up, we identified 32,456 cases of total cancer. Compared to current smokers, the risks for total and smoking-related cancer in past smokers were reduced to the level similar to never smokers after abstaining smoking for more than 26 years, with the hazard ratio of 0.69 (95% confidence interval [CI] = 0.63,0.76) for total cancer and 0.31 (95% CI = 0.26,0.37) for smoking related cancer, whereas no risk reduction was found for obesity-related cancer. Comparing former smokers to current smokers, the multivariable-adjusted hazard ratios for post-cessation weight gain of 0-5 kg, >5-10 kg, and ≥10 kg were 0.85 (95% CI = 0.81,0.89), 0.88 (95% CI = 0.83,0.93), and 0.93 (95% CI = 0.88,1.00) for total cancer; and 0.62 (95% CI = 0.58,0.67), 0.65 (95% CI = 0.60,0.71), and 0.71 (95% CI = 0.65,0.78) for total smoking-related cancer. In contrast, higher weight gain following smoking cessation was associated with a modest increased obesity-related cancer risk. Conclusion Smoking cessation overall has a strong net association with lower risk of total cancer irrespective of weight gain. However, this inverse association may be attenuated by substantial post-cessation weight gain, largely due to an increased risk of obesity-related cancers.
Article
Aims To summarise systematic reviews on tobacco addiction published by the Cochrane Tobacco Addiction Group (CTAG) from 2021 to 2023. Methods We identified all new and updated Cochrane Reviews published by CTAG between 2021 and 2023. We present key results from these reviews and discuss promising avenues for future research. Results CTAG published five new reviews and one overview of reviews, and updated eight reviews. Review evidence showed that all main pharmacotherapies (varenicline, cytisine, bupropion and nicotine replacement therapy [NRT], especially when patches are combined with fast acting forms like gum) are effective for smoking cessation, as are nicotine e‐cigarettes. Evidence suggested similar magnitude of effects of varenicline, cytisine, and nicotine e‐cigarettes; these emerged as the most effective treatments. Evidence also supported behavioural counselling and financial incentives for smoking cessation. Secondary analyses of the Cochrane review of e‐cigarettes for smoking cessation showed over half of participants assigned to e‐cigarette conditions were still using them at six months or longer, that biomarkers of potential harm significantly reduced in people switching from smoking to vaping or to dual use, and that there was insufficient evidence to draw associations between e‐liquid flavours and smoking cessation. Findings on mindfulness‐based interventions, interventions delivered by dental and primary care professionals, interventions to prevent weight gain after smoking cessation, and interventions for waterpipe cessation were less certain. Reviews of observational evidence showed that smoking cessation reduced cardiovascular events and mortality in people living with cardiovascular disease, and improved mental health. Conclusions Nicotine replacement therapy (especially patches combined with fast acting forms), varenicline, cytisine, bupropion, nicotine e‐cigarettes, behavioural counselling, and financial incentives are all effective ways to help people quit smoking. Quitting smoking improves mental health and reduces cardiovascular events and mortality in people living with cardiovascular disease.
Article
Background: Reports of reduced desire to smoke in patients treated with semaglutide, a glucagon-like peptide receptor agonist (GLP-1RA) medication for type 2 diabetes mellitus (T2DM) and obesity, have raised interest about its potential benefit for tobacco use disorders (TUDs). Objective: To examine the association of semaglutide with TUD-related health care measures in patients with comorbid T2DM and TUD. Design: Emulation target trial based on a nationwide population-based database of patient electronic health records. Setting: United States, 1 December 2017 to 31 March 2023. Participants: Seven target trials were emulated among eligible patients with comorbid T2DM and TUD by comparing the new use of semaglutide versus 7 other antidiabetes medications (insulins, metformin, dipeptidyl-peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors, sulfonylureas, thiazolidinediones, and other GLP-1RAs). Measurements: The TUD-related health care measures (medical encounter for diagnosis of TUD, smoking cessation medication prescriptions, and smoking cessation counseling) that occurred within a 12-month follow-up were examined using Cox proportional hazards and Kaplan-Meier survival analyses. Results: The study compared 222 942 new users of antidiabetes medications including 5967 of semaglutide. Semaglutide was associated with a significantly lower risk for medical encounters for TUD diagnosis compared with other antidiabetes medications, and was strongest compared with insulins (hazard ratio [HR], 0.68 [95% CI, 0.63 to 0.74]) and weakest but statistically significant compared with other GLP-1RAs (HR, 0.88 [CI, 0.81 to 0.96]). Semaglutide was associated with reduced smoking cessation medication prescriptions and counseling. Similar findings were observed in patients with and without a diagnosis of obesity. For most of the group comparisons, the differences occurred within 30 days of prescription initiation. Limitation: Documentation bias, residual confounding, missing data on current smoking behavior, body mass index, and medication adherence. Conclusion: Semaglutide was associated with lower risks for TUD-related health care measures in patients with comorbid T2DM and TUD compared with other antidiabetes medications including other GLP-1Ras, primarily within 30 days of prescription. These findings suggest the need for clinical trials to evaluate semaglutide's potential for TUD treatment. Primary funding source: National Institutes of Health.
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Background This overview of reviews aims to identify evidence on the benefits (i.e. tobacco use abstinence and reduction in smoking frequency) and harms (i.e. possible adverse events/outcomes) of smoking cessation interventions among adults aged 18 years and older. Methods We searched Medline, Embase, PsycINFO, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, the CADTH Health Technology Assessment Database and several other websites for grey literature. Searches were conducted on November 12, 2018, updated on September 24, 2020, with publication years 2008 to 2020. Two reviewers independently performed title-abstract and full-text screening considering pre-determined inclusion criteria. Data extraction and quality assessments were initially completed by two reviewers independently (i.e. 73% of included studies (n = 22)) using A Measurement Tool to Assess Systematic Reviews-2 (AMSTAR 2), and the remainder done by one reviewer and verified by another due to resources and feasibility. The application of Grading of Recommendations Assessment, Development and Evaluation (GRADE) was performed by one independent reviewer and verified by another. Results A total of 22 Cochrane systematic reviews evaluating the impact of smoking cessation interventions on outcomes such as tobacco use abstinence, reduction in smoking frequency, quality of life and possible adverse events were included. Pharmaceutical (i.e. varenicline, cytisine, nicotine replacement therapy (NRT), bupropion) and behavioural interventions (i.e. physician advice, non-tailored print-based self-help materials, stage-based individual counselling, etc.) showed to have increased smoking cessation; whereas, data for mobile phone-based interventions including text messaging, hypnotherapy, acupuncture, continuous auricular stimulation, laser therapy, electrostimulation, acupressure, St John’s wort, S-adenosyl-L-methionine (SAMe), interactive voice response systems and other combination treatments were unclear. Considering harms related to smoking cessation interventions, small/mild harms (i.e. increased palpitations, chest pain, nausea, insomnia, headache) were observed following NRT, varenicline and cytisine use. There were no data on harms related to behavioural therapies (i.e. individual or group counselling self-help materials, internet interventions), combination therapies or other therapies (i.e. laser therapy, electrostimulation, acupressure, St John’s wort, SAMe). Conclusion Results suggest that pharmacological and behavioural interventions may help the general smoking population quit smoking with observed small/mild harms following NRT or varenicline. Consequently, evidence regarding ideal intervention strategies and the long-term impact of these interventions for preventing smoking was unclear. Systematic review registration PROSPERO CRD42018099691
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Zusammenfassung Der Konsum von Tabak ist nach wie vor das größte vermeidbare Gesundheitsrisiko in Deutschland. Jährlich sterben über 127.000 Menschen vorzeitig an den Folgen des Tabakkonsums – jede fünfte Krebsneuerkrankung ist eine Folge des Rauchens. Während Deutschland im internationalen Vergleich mit der derzeitigen Tabakkontrollpolitik bestehend aus Werbeverboten, einer Förderung von rauchfreien Umgebungen sowie einem alleinigen Abstinenzparadigma nur sehr schleppend eine Veränderung herbeiführt, zeigen uns andere Länder, wie durch eine Integration von „Harm Reduction“ (Konzept der Schadensminimierung) als ergänzende Maßnahme sowie eine deutlich aktivere Unterstützung von ausstiegswilligen Menschen die Zahl der Raucher*innen gesenkt und dadurch Todesfälle verhindert werden können. Dieser Beitrag stellt zunächst die aktuelle Lage sowie die aktuellen Maßnahmen in Deutschland vor. Aus einem Blick in das Vereinigte Königreich, das mit seiner Tabakkontrollpolitik europaweit als Vorreiter gilt, sowie einer Zusammenfassung des aktuellen Forschungsstandes werden Empfehlungen für Veränderungen der derzeitigen Tabakkontrollpolitik in Deutschland abgeleitet.
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The association of cigarette smoking with several severe and very severe diseases (oncological, cardiovascular, respiratory) which have dramatic epidemiological, medical, and financial impact, is a well-known public threat. Asthma and chronic obstructive pulmonary disease (COPD) are highly prevalent diseases in Italy, posing significant public health challenges. Tobacco smoking, a primary risk factor for COPD and a common asthma trigger, remains a critical preventable public health issue. While universally acknowledged that quitting smoking drastically reduces the risk of smoking-related health issues, a significant portion of smokers and patients find quitting challenging or undesirable, hence a need for new ways to deal with it. A worth considering alternative might be the switch to electronic cigarettes (e-cig), and heat-not-burn/heated tobacco products (HnB/HTP). Emerging evidence suggests potential benefits in asthma and COPD management when transitioning from traditional smoking to e-cigs or HnB devices. However, the effectiveness of these products in facilitating smoking cessation is still debated, alongside concerns about their role in promoting smoking initiation among non-smokers. Internists are among the physicians who most frequently assist patients with smoking-related diseases, and in this perspective they cannot avoid paying attention to the progressive diffusion of smoking products alternative to the traditional cigarette, and to the controversies with respect to their use. In this context, the Italian Society of Internal Medicine, also recognizing a growing need for clarity for healthcare providers, has undertaken a comprehensive analysis of existing literature to offer an informed perspective on the health impact of e-cigs and HnB/HTP on asthma and COPD.
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Purpose Weight concern is a barrier to smoking cessation. We examined the impact of weight concern on post-cessation weight gain, abstinence and program engagement. Design Randomized-controlled trial. Setting Telephone-based and group-based intervention sessions. Subjects 305 participants were randomized and analyzed. Intervention Participants were randomized to receive a self-guided intervention, a weight loss intervention, or a weight stability intervention prior to all receiving the same smoking cessation intervention. Measures Level of weight concern on three measures, point-prevalence abstinence, weight change, and session attendance at 12 months. Analysis Continuous and discrete outcomes were compared between weight-concerned and non-weight-concerned participants using two-sample t-tests and chi-square tests respectively. Results There were no significant differences in weight change (range: +1.77, −1.91 kg) when comparing weight-concerned and non-weight-concerned participants. Point-prevalence abstinence ranged from 36% to 64%, with no differences by condition based on level of weight concern. There were no significant differences in session attendance by weight concern (Weight sessions: 50–70%, Smoking cessation sessions: 41–56%, Booster sessions: 28–45%). Weight concern, on all measures, significantly decreased between screening and 2 months (after the weight management intervention), for most of the comparisons made overall and by condition. Conclusion It may not be necessary to screen for weight concerns in smoking cessation and/or post-cessation weight management programs, as the trial interventions were beneficial regardless of weight concern.
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Introduction Smoking is harmful, and its cessation is recommended to prevent chronic kidney disease, which often begins with abnormal leakage of albumin in the urine, called albuminuria. Smoking cessation’s effect on albuminuria depends on the pack-years smoked, length of abstinence, body mass index (BMI) and glycosylated haemoglobin (HbA1c). Using the UK Biobank data, we examined the relationship between these cardiorenal variables and albuminuria. Methods For this study, we selected a UK Biobank cohort with urinary albumin concentration (UAC) in the first and second visits. Participants were divided into progressor and regressor groups, where progressors were defined as those with increased UAC value, and regressors were those with decreased UAC value. Three different logistic regression models were fitted. In model 1, with a cohort design, we explored the impact of a change in age, HbA1c and BMI between the first and second visits and the UAC. In model 2 and 3, in a cross-sectional design, we explored which cardiorenal risk factors were associated with a rise or fall of UAC at the time point of the second visit. Results are expressed in OR and 95% CI. Results The prevalence of albuminuria was highest in ex-smokers who started smoking between the ages of 13 and 18. With a mean duration of 51 months, there was no statistically significant relationship between smoking status and BMI with albuminuria. Each year of ageing and each unit of increase in HbA1c (mmol/mol) increased the odds of progression of albuminuria by 20% and 3%, respectively. In ex-smokers, at the time point of the second visit, each year of smoking increased, and each year of abstinence decreased the odds by 4% and 6%, respectively. Conclusion Smokers should be supported to stop smoking and remain abstinent despite short-term weight gain. Childhood smoking should be actively discouraged.
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Tobacco use disorder (TUD), the leading cause of preventable deaths in the United States, disproportionally impacts those with psychiatric disorders. There are multiple first-line, U.S. Food and Drug Administration–approved pharmacotherapy options for the treatment of TUD. The current review focuses on these medications, underlining practical tips to improve cessation rates, while emphasizing a harm reduction and patient-centered approach to treatment. [ Journal of Psychosocial Nursing and Mental Health Services, 61 (11), 6–9.]
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The Cochrane Tobacco Addiction Group has created risk of bias tools which are topic-agnostic. In 2012 the Cochrane Tobacco Addiction Group created guidance specific to considerations for reviews of randomized controlled trials of tobacco cessation interventions, building on existing Cochrane tools. The guidance covers issues relating to selection bias, performance bias, detection bias, attrition bias, and selective reporting. In this paper, we set out to make this guidance publicly available, so that others can use and cite it. We provide advice for using this tool to appraise trials critically as a systematic reviewer. We also provide guidance for triallists on ways to use this tool to improve trial design and reporting.
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Introduction: Interest in wellness interventions in substance use disorder (SUD) treatment is growing although evidence remains limited. This study evaluated nutrition, physical activity, nutrition and physical activity counseling, and relationships of counseling with wellness behavior before and after a wellness-oriented, tobacco-free policy intervention in 17 residential SUD programs. Methods: Clients completed cross-sectional surveys reporting sugar-sweetened beverage consumption, physical activity, and receipt of nutrition and physical activity counseling before (n= 434) and after (n = 422) an 18-month intervention. Multivariable regression models assessed pre-post-intervention differences in these variables and examined associations of nutrition counseling with sugar-sweetened beverage consumption and physical activity counseling with physical activity. Results: Post-intervention clients were 83% more likely than pre-intervention clients to report nutrition counseling (p = 0.024). There were no pre-post- differences for other variables. Past week sugar-sweetened beverage consumption was 22% lower among clients reporting nutrition counseling than for those who did not (p = 0.008) and this association did not vary by time (pre/post). There was a significant interaction of physical activity counseling receipt by time on past week physical activity (p = 0.008). Pre-intervention clients reporting physical activity counseling had 22% higher physical activity than those who did not; post-intervention clients reporting physical activity counseling had 47% higher physical activity. Conclusion: A wellness policy intervention was associated with increased nutrition counseling. Nutrition counseling predicted lower sugar-sweetened beverage consumption. Physical activity counseling predicted higher physical activity, an association that was greater post-intervention. Adding wellness components to tobacco-related interventions may promote health among SUD clients.
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Background The majority of Norwegians who use e-cigarettes are adults who have smoked. Little is known about vaping reasons and -patterns in this group. The aim of this paper was to study vaping prevalence, patterns, and motivations among adults who smoke. Furthermore, to investigate smoking intensity and smoking cessation behaviour differences between those who vape and those who do not. Methods This study was based on two separate Norwegian samples: People who had ever smoked, from 2017 (N = 2099), and people who currently smoked and recent quitters, from 2018/2019 (N = 1336). Measures of vape frequencies, vape motives, and smoking cessation behaviours were utilised in descriptive analyses of relationships between vaping and smoking behaviour. Results Less than 1 in 10 in the ever-smoked group, 1 in 5 of the currently smoked or recently quit group, were currently vaping. Ever trial rates for vaping were much higher at 1 in 3 in the ever-smoked group, and 1 in 2 in the currently smoked or recently quit group. Dual use with combustible cigarettes was common, but people who smoked tended to use e-cigarettes less frequently while those who formerly smoked tended to use them more frequently. Both quitting attempts and smoking intensity reduction were positively associated with vaping, and the most common reasons for e-cigarette use were reported to be desires to reduce harm, to stop smoking, or to reduce smoking intensity. Conclusion The results indicate that Norwegians who smoke tend to see e-cigarettes as a tool to reduce or completely stop smoking. The predominance of use-motivations related to reducing harm points at the importance of conveying correct information about relative harmfulness of tobacco- and nicotine products.
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Background: Post-cessation weight gain (PCWG) is an obstacle to smoking cessation. This trial evaluated a behavioral intervention targeting alternative rewards to smoking and high calorie snacking to promote smoking cessation while mitigating PCWG. Methods: Adult smokers (n = 288; 119 females, 169 males) received eight weeks of transdermal nicotine and were randomized to eight sessions of behavioral activation for smoking cessation and the mitigation of PCWG (BAS+) or standard smoking cessation counseling (SC). Primary outcomes were 7-day point prevalence abstinence and PCWG 26 weeks after the target quit date. Change in caloric intake from pre-treatment through the 26-week follow-up was a secondary outcome. Data were collected from September 2016 to February 2021, and analyses were completed in July 2022. Results: BAS+ and SC did not differ in smoking abstinence rates at the 26-week follow-up (OR=0.80, 95%CI 0.50-1.27, p = 0.34; 18% versus 23%). There were no significant differences in PCWG between BAS+ and SC who were 7-day point prevalence abstinent (β = -0.29, 95%CI -2.13 to 1.65, p = 0.77; 2.60 versus 2.20 pounds, respectively) or among those continuously abstinent (5.78 versus 5.34 pounds, respectively). There were no significant differences in caloric intake between BAS+ and SC from baseline to the 26-week follow-up (β = 110.65, 95%CI -96.72 to 318.02, p = 0.30; -19.1 versus -116.9 kcals/day, respectively). Conclusions: The results do not support the efficacy of BAS+ for smoking cessation and the prevention of PCWG. These findings join a growing body of research highlighting the challenge of minimizing PCWG and promoting smoking abstinence.
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Purpose of Review The recent rise in cardiovascular disease (CVD) deaths in the USA has sparked interest in identifying and implementing effective strategies to reverse this trend. Healthy lifestyle behaviors (i.e., healthy diet, regular physical activity, achieve and maintain a healthy weight, avoid tobacco exposure, good quality sleep, avoiding and managing stress) are the cornerstone for CVD prevention. Recent Findings Achieving all of these behaviors significantly benefits heart health; however, even small changes lower CVD risk. Moreover, there is interplay among healthy lifestyle behaviors where changing one may result in concomitant changes in another behavior. In contrast, the presence of one or more unhealthy lifestyle behaviors may attenuate changing another lifestyle behavior(s) (poor diet, inadequate physical activity, overweight/obesity, poor sleep quality, tobacco exposure, and poor stress management). Summary It is important to assess all of these lifestyle behaviors with patients to plan an intervention program that is best positioned for adherence.
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Background Smoking is a major risk factor for cardiovascular disease and smoking cessation reduces excess risk. E-cigarettes are popular for smoking cessation but there is little evidence on their cardiovascular health effect. Our objective was to compare the medium- and longer-term cardiovascular effects in smokers attempting to quit smoking using e-cigarettes with or without nicotine or prescription nicotine replacement therapy (NRT). Methods This was a single-center, pragmatic three-arm randomized (1:1:1) controlled trial, which recruited adult smokers (≥ 10 cigarettes/day), who were willing to attempt to stop smoking with support ( n = 248). Participants were randomized to receive behavioral support with either (a) e-cigarettes with 18 mg/ml nicotine, (b) e-cigarettes without nicotine, and (c) NRT. Flow-mediated dilation (%FMD) and peak cutaneous vascular conductance (CVCmax) responses to acetylcholine (ACh) and sodium nitroprusside (SNP), mean arterial pressure (MAP), and other outcomes were recorded at baseline, 3, and 6 months after stopping smoking. Data were analyzed using generalized estimating equations (GEE). Results At 3- and 6-month follow-up, %FMD showed an improvement over baseline in all three groups (e.g., p < 0.0001 at 6 months). Similarly, ACh, SNP, and MAP improved significantly over baseline in all groups both at 3 and 6 months (e.g., ACh: p = 0.004, at 6 months). Conclusions Smokers attempting to quit experienced positive cardiovascular impact after both a 3- and 6-month period. None of the groups (i.e., nicotine-containing and nicotine-free e-cigarettes or NRT) offered superior cardiovascular benefits to the others. Trial registration ClinicalTrials.gov NCT03061253 . Registered on 17 February 2017.
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Background Smoking cessation is the most effective means of slowing the decline of lung function associated with chronic obstructive pulmonary disease (COPD). While effective smoking cessation treatments are available, they are underutilized and nearly half of people with COPD continue to smoke. By addressing both nicotine and behavioral dependence, electronic cigarettes (EC) could help people with COPD reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely. The purpose of this pilot study is to identify barriers and facilitators to the use of and assess the preliminary effectiveness of EC as a harm reduction strategy among people with COPD. Methods In an open-label two-arm randomized controlled trial pilot study, 60 patients identified as smokers with a COPD diagnosis via electronic health records from a large urban health center are randomized in a 1:1 ratio to either standard care [counseling + nicotine replacement therapy (NRT)] or counseling + EC. The NRT arm will receive nicotine patches and nicotine lozenges for 12 weeks. The EC arm will receive EC for 12 weeks. Both cohorts will receive counseling from a licensed mental health counselor. Using ecological momentary assessment, participants will report their use of CC in both arms and EC use in the EC arm daily via text message. Primary outcomes will be feasibility and acceptability of intervention, and secondary outcomes will be reduction in CPD and change in COPD symptoms as measured by COPD Assessment Tool (CAT) score at 12-weeks. EC displacement of CC. To explore attitudes towards the use of EC as a harm-reduction strategy for patients with COPD, interviews will be performed with a sample of participants from both study arms. Discussion Despite decades of availability of smoking cessation medications, nearly half of people with COPD still smoke. This study aims to address the unmet need for feasible and effective strategies for reducing CC use among those with COPD, which has the potential to significantly improve the health of people with COPD who smoke. Trial Registration ClinicalTrials.gov Identifier: NCT04465318.
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With the recent rapid increase in obesity worldwide, metabolic syndrome (MetS) has gained significant importance. MetS is a cluster of obesity-related cardiovascular risk factors including abdominal obesity, atherogenic dyslipidemia, high blood pressure and impaired glucose tolerance. MetS is highly prevalent and strongly associated with an increased risk of developing diabetes and cardiovascular disease, putting a great burden on human society. Therefore, it is very important to reduce MetS risk, which can improve patients' cardiovascular prognosis. The primary and most effective strategy to control each component of MetS is lifestyle change such as losing body weight, keeping regular exercise, adopting a healthy diet, quitting smoking and alcohol drinking in moderation. Many studies have shown that lifestyle modification has improved all components of MetS, and reduces the incidence of diabetes and cardiovascular disease. Here, the Korean Society of CardioMetabolic Syndrome has summarized specific and practical methods of lifestyle modification in the management of MetS in the healthcare field.
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Introduction Tobacco harm reduction has potential to improve individual and population health. However, little research exists on low-intensity interventions, such as encouraging longer-term NRT or e-cigarette use. We aimed to determine whether: 1) encouraging use of nicotine products as long-term tobacco substitutes is more effective for smoking abstinence than standard treatment, and 2) offering e-cigarettes is more effective than NRT. Methods An open-label, parallel group randomised trial was conducted in Australia between 2014 and 2015, with 1563 adult daily smokers, randomised to: A) Standard cessation advice and NRT: advice to use NRT short-term B) Quit or substitute advice and NRT: advice to use NRT as a longer-term substitute for smoking if required to maintain smoking cessation or C) Quit or substitute advice and NRT and/or e-cigarettes. Participants were offered an initial supply of products they could then purchase for up to 7 months. The primary outcome was self-reported continuous smoking abstinence at 7 months. Point prevalence, dual use, and cigarette reduction were secondary outcomes. Results At 7 months, 2.8% (N=9) of group A (N=324) were abstinent, compared with 1.8% (N=11) in B (N=620) and 1.3% (N=8) in C (N=619) (Adjusted ORs: B vs A 0.66, 95% CI: 0.27-1.63; C vs A 0.46, 95% CI: 0.17-1.21; C vs B 0.69, 95% CI 0.27–1.73). There were no suspected unexpected serious adverse reactions associated with trial products. Conclusion A free trial of NRT and first generation e-cigarettes and advice on long-term substitution was no better for smoking abstinence than usual care. Implications This pragmatic trial allowed the comparison of existing and alternative policy options under semi-realistic conditions, such as product choice and financial cost. All trial arms had low rates of smoking cessation. The findings suggest that providing unflavoured cigalike e-cigarettes without additional support may not increase quitting compared with advice to use standard NRT in a general population of Australians who smoke. More intensive support and education, and/or opportunity to try a range of e-cigarette products, may be required to motivate quit attempts using e-cigarettes.
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This study investigated predictors for smoking abstinence at 12-week follow-up among 85 smokers with a past history of alcohol dependence enrolled in a smoking cessation trial. Length of alcohol abstinence at time of enrollment and longest previous period of smoking abstinence were significantly associated with smoking status at follow-up. Multiple logistic regression with these variables entered as predictors suggested that longest previous period of smoking abstinence partially mediated the relationship between length of alcohol abstinence at enrollment and smoking status at follow-up. Additional research is warranted to identify predictors of nicotine abstinence and smoking relapse in this population and to understand the factors that mediate the relationship between length of alcohol abstinence at enrollment and smoking outcome.
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This study examined baseline predictors associated with smoking abstinence among 205 smokers (113 men, 92 women) with a past history of alcoholism. Their mean age was 41.8 years, and 93% were Caucasian. Participants were randomly assigned to standard treatment (ST), behavioral counseling plus exercise (BEX), or behavioral counseling plus nicotine gum (BNIC). Factors multivariately associated with point-prevalence smoking abstinence at posttreatment (1 week after target quit date) were a longer duration of prior smoking abstinence and an interaction between treatment group and having an active 12-step sponsor. ST was more effective for those with an active sponsor, whereas both BEX and BNIC were more effective for those without an active sponsor. At 1-year follow-up, independent predictors of point-prevalence smoking abstinence were a lower Fagerström Tolerance Questionnaire score (K. O. Fagerström, 1978) and fewer years of smoking.
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Few researchers have studied whether weight gain has an impact on short-term relapse to smoking. The authors of this study investigated predictors of relapse among 989 participants (60% women) in a randomized, double-blind, 10-week multicenter trial to determine the effect of fluoxetine (30 or 60 mg) versus placebo in combination with behavioral counseling for smoking cessation. Medication compliance and smoking status were biochemically verified. At Visit 2, participants were asked to set a quit date within the subsequent 2 visits. A proportional hazards regression model was used to predict risk of relapse within the first 3 months of quitting. Weight gain predicted relapse, but for men only. Female gender also predicted relapse. The results led the authors to question whether postcessation weight gain interventions should be restricted to women smokers.
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The authors examined whether serum fluoxetine levels influence behavioral treatment adherence and smoking cessation outcome. Nondepressed smokers (N = 989) from 16 centers were randomized on a double-blind basis to receive either fluoxetine (30 or 60 mg) or placebo plus 9 sessions of behavioral smoking cessation treatment. Fluoxetine and norfluoxetine blood levels were assayed 1 week after the quit date. Logistic regression was used to predict treatment completion and cessation outcome, controlling for gender, age, treatment site, and degree of nicotine dependence. Higher steady-state fluoxetine blood levels (fluoxetine + norfluoxetine) predicted less likelihood of dropping out, χ²(1, N = 820) = 3.9, p < .05, and more likelihood of being abstinent, χ²(1, N = 513) = 18.1, p < .001. Attaining a higher fluoxetine blood level improved the likelihood of completing behavioral treatment and increased the probability of achieving abstinence.
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A total of 424 smokers were randomized in a 2 × 2 factorial experiment. A pharmacologic factor contained 2 levels: transdermal nicotine patch (TNP; 21 mg) and placebo. A self-help behavioral treatment factor contained 2 levels: video-enhanced self-help treatment manual and self-help treatment manual only. At 2 months, TNP produced a higher level of abstinence (36%) than placebo (20%), p < .001. No other comparison was significant. In secondary analyses, (at 2 months) and compliance with patch treatment regimen (at 2, 6, and 12 months) were associated with less relapse. Although nicotine replacement therapy has improved our ability to produce smoking cessation, the production of sustained, longer term abstinence remains an elusive goal.
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Participants in an 8-session, community-based smoking cessation intervention rated whether they would stay quit if they experienced weight gain. The majority reported that they would not relapse to smoking, even after a 20-lb. (9.07-kg) weight gain. Those who were weight concerned were more likely to be female, to weigh less and be normal or underweight, and to report chronic dieting. This group was also significantly less likely to be abstinent posttreatment, and at the 1-, 6- and 12-month follow-ups. Individuals presenting for formal smoking cessation interventions may be less weight concerned than the general population of smokers. However, weight-concerned smokers who do present for treatment are less likely to quit smoking. Implications for recruitment and intervention are discussed.
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Earlier research indicated that a 10-session mood management (MM) intervention was more effective than a 5-session standard intervention for smokers with a history of major depressive disorder (MDD). In a 2 × 2 factorial design, the present study compared MM intervention to a contact-equivalent health education intervention (HE) and 2 mg to 0 mg of nicotine gum for smokers with a history of MDD. Participants were 201 smokers, 22% with a history of MDD. Contrary to the earlier findings, the MM and HE interventions produced similar abstinence rates: 2 mg gum was no more effective than placebo. History-positive participants had a greater increase in mood disturbance after the quit attempt. Independent of depression diagnosis, increases in negative mood immediately after quitting predicted smoking. No treatment differences were found in trends over time for measures of mood, withdrawal symptoms, pleasant activities and events, self-efficacy, and optimism and pessimism. History-positive smokers may be best treated by interventions providing additional support and contact, independent of therapeutic content.
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The authors examined weight gain in 79 abstinent cigarette smokers during treatment with placebo or with 2 mg or 4 mg of nicotine gum. Results indicated that nicotine gum suppressed weight gain in a linear fashion with increasing nicotine dose. At 90 days postcessation, placebo gum users gained 3.7 kg, 2-mg gum users gained 2.1 kg, and 4-mg gum users gained 1.7 kg. Assessment of nicotine replacement by means of pre- and postcessation salivary cotinine levels revealed that smokers who replaced a greater percentage of their baseline cotinine levels during treatment gained less weight. Percentage of baseline cotinine replaced remained related to weight gain after the number of pieces of gum used was controlled. Implications for smokers hoping to minimize postcessation weight gain are discussed.
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1,218 smokers able to quit smoking for 48 hr were randomly assigned to one of 12 cells in a 4 × 3 fully crossed factorial experiment. A pharmacologic factor contained four levels: nicotine polacrilex (gum) delivered ad lib or on a fixed regimen, placebo gum, and no gum. A self-guided behavioral treatment factor contained three levels: self-selected relapse prevention modules, randomly administered modules, and no modules. Those receiving nicotine gum were more likely to be abstinent at the 2- and 6-month follow-ups. The fixed regimen accounted for most of the effect for gum. There was no effect for the relapse prevention module factor. Men and women showed a differential treatment response. Men who received nicotine gum were more likely to be abstinent at each follow-up (2, 6, and 12 months). No treatment was significantly better among women. We conclude that research on different gum chewing regimens is warranted and that further examination of possible gender differences in response to replacement therapy is needed.
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Introduction: Smoking reduction can lead to increased success in quitting. This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit. This paper reports the study design and methods. Methods and analysis: A pragmatic, multicentred, parallel, two group, randomised controlled superiority clinical trial, with embedded process evaluation and economics evaluation. Participants who wished to reduce smoking with no immediate plans to quit were randomised 1:1 to receive either (1) tailored individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control). Participants in both arms of the trial were also signposted to usual local support for smoking reduction and quitting. The primary outcome measure is 6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire at 3 and 9 months post-baseline. Participants confirmed as abstinent at 9 months will be followed up at 15 months. Ethics and dissemination: Approved by SW Bristol National Health Service Research Committee (17/SW/0223). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will be disseminated to trial participants and healthcare providers. Trial registration number: ISRCTN47776579; Pre-results.
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Background: Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD), and it contributes to the development of many other serious diseases. Smoking cessation in COPD patients is known to improve survival and reduce the number of hospitalization-requiring acute exacerbations of COPD. However, smoking cessation interventions in these patients have only been successful for approximately 15-20% for consistent smoking abstinence in 12 months. Thus, more effective interventions are needed for this patient group. The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD. Methods: This study is a randomized controlled trial. A total of 600 active smokers with COPD will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation program, "low intensity" group) or an intervention ("high-intensity" group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and "buddy-matching" (smoker matched with COPD patient who has ceased smoking). Both groups will receive pharmacological smoking cessation. The primary endpoint is anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation after 12 months. Discussion: The potential benefit of this project is to improve smoking cessation rates and thereby reduce smoking-related exacerbations of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of other smoking-related diseases. Trial registration: ClinicalTrials.gov NCT04088942 . Registered on 13 September 2019.
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Summary Background Smoking cessation is important in patients with tuberculosis because it can reduce the high rates of treatment failure and mortality. We aimed to assess the effectiveness and safety of cystine as a smoking cessation aid in patients with tuberculosis in Bangladesh and Pakistan. Methods We did a randomised, double-blind, placebo-controlled, trial at 32 health centres in Bangladesh and Pakistan. Eligible patients were adults (aged >18 years in Bangladesh; aged >15 years in Pakistan) with pulmonary tuberculosis diagnosed in the previous 4 weeks, who smoked tobacco on a daily basis and were willing to stop smoking. Patients were randomly assigned (1:1) to receive behavioural support plus either oral cytisine (9 mg on day 0, which was gradually reduced to 1·5 mg by day 25) or placebo for 25 days. Randomisation was done using pregenerated block randomisation lists, stratified by trial sites. Investigators, clinicians, and patients were masked to treatment allocation. The primary outcome was continuous abstinence at 6 months, defined as self-report (of not having used more than five cigarettes, bidis, a water pipe, or smokeless tobacco products since the quit date), confirmed biochemically by a breath carbon monoxide reading of less than 10 parts per million. Primary and safety analysis were done in the intention-to-treat population. This trial is registered with the International Standard Randomised Clinical Trial Registry, ISRCTN43811467, and enrolment is complete. Findings Between June 6, 2017, and April 30, 2018, 2472 patients (1527 patients from Bangladesh; 945 patients from Pakistan) were enrolled and randomly assigned to receive cytisine (n=1239) or placebo (n=1233). At 6 months, 401 (32·4%) participants in the cytisine group and 366 (29·7%) participants in the placebo group had achieved continuous abstinence (risk difference 2·68%, 95% CI −0·96 to 6·33; relative risk 1·09, 95% CI 0·97 to 1·23, p=0·114). 53 (4·3%) of 1239 participants in the cytisine group and 46 (3·7%) of 1233 participants in the placebo group reported serious adverse events (94 events in the cytisine group and 90 events in the placebo group), which included 91 deaths (49 in the cytisine group and 42 in the placebo group). None of the adverse events were attributed to the study medication. Interpretation Our findings do not support the addition of cytisine to brief behavioural support for the treatment of tobacco dependence in patients with tuberculosis.
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Background: Smoking cessation is a persistent leading public health challenge. Mobile health (mHealth) solutions are emerging to improve smoking cessation treatments. Previous approaches have proposed supporting cessation with tailored motivational messages. Some managed to provide short-term improvements in smoking cessation. Yet, these approaches were either static in terms of personalization or human-based nonscalable solutions. Additionally, long-term effects were neither presented nor assessed in combination with existing psychopharmacological therapies. Objective: This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology. Methods: A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence-generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. The technical solution was assessed according to the precision of the tailored motivational smoking cessation messages and user engagement. Cessation and no cessation subgroups were compared using t tests. A voluntary satisfaction questionnaire was administered at the end of the intervention to all participants who completed the trial. Results: In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (P=.84). None of the clinical secondary objective measures showed relevant differences between the groups. The system was able to learn and tailor messages for improved effectiveness in supporting smoking cessation but was unable to reduce the time between a message being sent and opened. In either case, there was no relevant difference between the cessation and no cessation subgroups. However, a significant difference was found in system engagement at 6 months (P=.04) but not in all subsequent months. High system appreciation was reported at the end of the study. Conclusions: The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. It provides a basis for artificial intelligence-based future approaches. Trial registration: ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/NCT03553173. International registered report identifier (irrid): RR2-10.2196/12464.
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Background Smoking cessation improves morbidity and mortality among smokers who achieve long-term abstinence. Many smokers are using e-cigarettes to attempt to quit, despite a lack of data concerning their efficacy and safety for smoking cessation. Methods The Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) trial is a multi-centre randomized controlled trial (NCT02417467) with a treatment period of 12 weeks and follow-up of 52 weeks. A total of 376 participants motivated to quit smoking were enrolled at 17 Canadian centres (November 2016 to September 2019). Participants were randomized (1:1:1) to one of three treatment arms: nicotine e-cigarettes, non-nicotine e-cigarettes, or no e-cigarettes. All groups received individual counselling. Treatment allocation was double-blind for the e-cigarette groups. The trial includes follow-ups by telephone at weeks 1, 2, 8, and 18, and clinic visits at weeks 4, 12, 24, and 52. The primary endpoint is to compare nicotine e-cigarettes to counselling alone in terms of biochemically-validated point-prevalence smoking abstinence at 12 weeks; the primary endpoint was changed from 52 weeks following early termination (77% of targeted enrollment) due to a prolonged delay in e-cigarette manufacturing. The secondary objectives are to examine the efficacy of nicotine and non-nicotine e-cigarettes in terms of point-prevalence and continuous smoking abstinence, and reduction in daily cigarette consumption at all follow-ups through week 52, and to describe the occurrence of adverse events. Conclusion The E3 Trial will provide regulators, health care professionals, and smokers with important information about the efficacy and safety of e-cigarettes for smoking cessation.
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Introduction: Most people who stop smoking gain weight. Dietary modification may seem an obvious solution, but food restriction may increase cigarette craving and smoking relapse. Trial design: An unblinded parallel randomised controlled trial. Methods: Participants were adult smokers with a body mass index greater or equal to 23 kg/m2. Setting was National Health Service commissioned Stop Smoking Services, interventions were referral to a commercial weight management programme, plus stop smoking support (treatment group), compared with stop smoking support alone (control group). Objective was to compare weight change between interventions in smoking abstainers and not abstinent rates in all. Primary outcome was change in weight (kg) at 12 weeks. Randomisation sequence was computer generated and concealed until allocation. Results: Seventy-six participants were recruited, 37 were randomised to the treatment group and 39 to the control group. Change in weight was analysed in long-term abstainers (13 treatment, 14 control) only because the aim was to prevent weight gain associated with smoking cessation. Abstinence was analysed on an intention-to-treat basis (37 treatment, 39 control). At 12 weeks weight gain was less in the treatment than the control group with an adjusted mean difference of -2.3 kg 95% CI (-4.4 to -0.1). Craving scores were lower (Mood and Physical Symptoms Scale craving domain -1.6 (-2.7 to -0.5)) and quit rates were higher in the treatment than the control group (32% vs 21%), although the trial was not powered to superiority in cravings and quit rates. No adverse events or side effects were reported. Conclusion: In people who are obese and want to quit smoking, these data provide modest encouragement that providing weight management at the time of quitting may be helpful. Those who are not obese, but who are informed about potential weight gain during their quit attempt, were uninterested in a weight management programme. Trial registration number: ISRCTN65705512.
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Background: Smoking rates are high in adults with anxiety disorders (ADs), yet little is known about the safety and efficacy of smoking-cessation pharmacotherapies in this group. Methods: Post hoc analyses in 712 smokers with AD (posttraumatic stress disorder [PTSD], n = 192; generalized anxiety disorder [GAD], n = 243; panic disorder [PD], n = 277) and in a nonpsychiatric cohort (NPC; n = 4,028). Participants were randomly assigned to varenicline, bupropion, nicotine-replacement therapy (NRT), or placebo plus weekly smoking-cessation counseling for 12 weeks, with 12 weeks follow-up. General linear models were used to test the effects of treatment group, cohort, and their interaction on neuropsychiatric adverse events (NPSAEs), and continuous abstinence weeks 9-12 (treatment) and 9-24 (follow-up). Results: NPSAE incidence for PTSD (6.9%), GAD (5.4%), and PD (6.2%) was higher versus NPC (2.1%), regardless of treatment. Across all treatments, smokers with PTSD (odds ratio [OR] = 0.58), GAD (OR = 0.72), and PD (OR = 0.53) had lower continuous abstinence rates weeks 9-12 (CAR9-12) versus NPC. Varenicline demonstrated superior efficacy to placebo in smokers with GAD and PD, respectively (OR = 4.53; 95% confidence interval [CI] = 1.20-17.10; and OR = 8.49; 95% CI = 1.57-45.78); NRT was superior to placebo in smokers with PD (OR = 7.42; 95% CI = 1.37-40.35). While there was no statistically significant effect of any treatment on CAR9-12 for smokers with PTSD, varenicline improved 7-day point prevalence abstinence at end of treatment in this subcohort. Conclusion: Individuals with ADs were more likely than those without psychiatric illness to experience moderate to severe NPSAEs during smoking-cessation attempts, regardless of treatment. While the study was not powered to evaluate abstinence outcomes with these subgroups of smokers with ADs, varenicline provided significant benefit for cessation in those with GAD and PD, while NRT provided significant benefit for those with PD.
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Data on the association between lung function and some dietary patterns have been published. However, it is not yet well known if whether the Mediterranean Diet (MD) pattern can preserve or improve lung function. Our purpose is to evaluate the effect of increased MD adherence on lung function in smokers. A multicenter, parallel, cluster-randomized, controlled clinical trial is proposed. A total of 566 active smokers (>10 packs-year), aged 25–75 years will be included, without previous respiratory disease and who sign an informed consent to participate. Twenty Primary Care Centres in Tarragona (Spain) will be randomly assigned to a control or an intervention group (1:1). All participants will receive advice to quit smoking, and the intervention group, a nutritional intervention (2 years) designed to increase MD adherence by: (1) annual visit to deliver personalized nutritional education, (2) annual telephone contact to reinforce the intervention, and (3) access to an online dietary blog. We will evaluate (annually for 2 years): pulmonary function by forced spirometry and MD adherence by a 14-item questionnaire and medical tests (oxidation, inflammation and consumption biomarkers). In a statistical analysis by intention-to-treat basis, with the individual smoker as unit of analysis, pulmonary function and MD adherence in both groups will be compared; logistic regression models will be applied to analyze their associations. We hope to observe an increased MD adherence that may prevent the deterioration of lung function in smokers without previous respiratory disease. This population may benefit from a dietary intervention, together with the recommendation of smoking cessation.
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Objective: To evaluate the efficacy in smoking cessation and safety of 2 and 4 mg nicotine mint lozenges in Chinese adult smokers. Methods: This was a multicenter, randomized, stratified, double-blind, placebo-controlled, parallel-group study. The low-dependence stratum included 483 smokers (241 randomized to active 2 mg nicotine lozenge and 242 to placebo lozenge). The high-dependence stratum included 240 smokers (120 randomized to active 4 mg nicotine lozenge and 120 to placebo lozenge). The primary endpoint was successful smoking cessation at 6 weeks postquit, defined as continuous abstinence from smoking for the 28-day period up to and including the 6-week visit (verified by CO measurement). Cochran-Mantel-Haenszel tests were performed to compare quit rates between active nicotine and placebo separately for the high-dependence and low-dependence strata. Results: The primary analysis showed that in the low-dependence (2 mg) stratum, 59 subjects (24.5%) of 241 in the active nicotine group and 52 subjects (21.5%) of 242 in the placebo group were successful quitters (P = .3851). In the high-dependence (4 mg) stratum, 37 subjects (30.8%) of 120 in the active nicotine group and 24 subjects (20.2%) of 119 in the placebo group were successful quitters (P = .0565). Conclusions: The 4 mg nicotine lozenge provided a directionally significant improvement in smoking cessation rates compared with placebo in Chinese adult smokers with high nicotine dependence for the primary endpoint. The 2 mg nicotine lozenge provided higher, but nonsignificant, smoking cessation rates than placebo. Both nicotine lozenges were generally well tolerated in Chinese adult smokers.
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Tobacco smoking is a global pandemic that poses substantial health burdens and costs. With nearly six million deaths annually, smoking is the single most important cause of avoidable premature mortality in the world, mainly from lung cancer, coronary heart disease, chronic obstructive pulmonary disease and stroke. Smoking is a very difficult addiction to break, even for those with a strong desire to quit. Electronic cigarettes are an attractive long-term alternative source of nicotine to conventional cigarettes because of their many similarities with smoking. Electronic cigarette users report buying them to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, to quit, and to continue having a 'smoking' experience, but with reduced health risks. Actually, there aren't antismoking treatments for people who smoke only electronic cigarette (single users) or electronic cigarette and classic cigarette (dual users). There isn't any specific information on the efficacy and safety of new pharmacological support for electronic cigarette users. We propose that smoking cessation with varenicline plus counselling delivered to electronic cigarette users could be associated with similar smoking abstinence rates compared to the results obtained in the general population. Herein, we describe the methodology of a double-blind, placebo-controlled, randomized clinical trial, of 24 weeks duration, that examines the efficacy of varenicline (1 mg BID - for 12 weeks) plus counselling compared to matched placebo (1 mg BID - for 12 weeks) plus counselling.
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Introduction Electronic cigarettes (EC) mainly with nicotine content are widely used worldwide. Although the number of publications about its use is increasing exponentially, evidence-based, unbiased, conclusive, head-to-head comparisons about its efficacy and safety as an aid for smoking cessation are lacking. Methods and analysis Design: randomised, placebo and reference treatment-controlled, multicentre, double-blind, double-dummy, parallel-group trial. Participants: smokers smoking at least 10 cigarettes/day in the past year and motivated to quit, aged 18–70 years. Interventions : (A) EC without nicotine (ECwoN) plus placebo tablets of varenicline administered by oral route: placebo condition , (B) EC with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition. Voltage regulated EC will be used with liquid containing 12 mg/mL of nicotine for ad libitum use. Flavour : blond tobacco. (C) Reference : ECwoN plus 0.5 mg varenicline tablets: varenicline condition. Varenicline administered according to the marketing authorisationauthorisation. Treatment duration : 1 week+3 months. Primary outcome: continuous smoking abstinence rate (CAR) (abstinence from conventional/combustible cigarettes) during the last 4 weeks (weeks 9–12) of the treatment period defined as self-report of no smoking during the previous 2 weeks and expired air carbon monoxide ≤8 at visit 4 at week 10 after target quit date (TQD), that is, 11 weeks after treatment initiation AND at visit 5, week 12 after TQD, that is, 13 weeks after treatment initiation. Secondary outcomes : safety profile; point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption; craving for tobacco and withdrawal symptoms with respect of baseline. Ethics and dissemination The ethics committee approval was obtained on 17 April 2018. All data collected about the study participants will be anonymised. Investigators will communicate trial results to participants, health authorities, healthcare professionals, the public and other relevant groups without any publication restrictions. Trial registration number NCT03630614 ; Pre-results.
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Background: Weight gain frequently occurs after smoking cessation (SC); the risk of new-onset diabetes mellitus increases for several years after SC. However, no large-scale, randomized controlled trials have examined the effects of nutritional guidance on post-SC cardiovascular risk. The current trial will enroll individuals who successfully quit smoking with the help of a SC clinic and who gain weight, to determine the effects of nutritional guidance on cardiovascular, glucose, and lipid metabolism biomarkers. Methods/design: This is a multicenter, prospective, parallel-group, randomized controlled trial. Some 250 individuals who successfully quit smoking with the help of a SC clinic and who gain weight (an increase of ≥ 1.25% Body Mass Index (BMI) between the first and the fifth visit to the SC clinic) will be enrolled within 1 month of the final (fifth) visit to the SC clinic. These participants will be randomly assigned to an intervention group (125 individuals receiving nutritional guidance) or a control group (125 individuals not receiving nutritional guidance). A registered dietitian will provide nutritional guidance once every 3 months for a total of three sessions. The primary endpoint for this trial will be the level of adiponectin, a predictor of cardiovascular risk that reflects weight and smoking status. Secondary endpoints will be levels of cardiovascular, glucose, and lipid metabolism biomarkers, BMI, abdominal circumference, and the percentage of individuals who quit smoking for a prolonged period. Discussion: This trial will determine the benefits of nutritional guidance with respect to post-SC weight gain. The findings should provide useful information for devising a quality protocol for SC education to prevent cardiovascular disease. Trial registration: The study is registered at the University Hospital Medical Information Network Clinical Trials Registry ( UMIN000030282 ). Registered on 6 December 2017.
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Background Nicotine preloading means using nicotine replacement therapy prior to a quit date while smoking normally. The aim is to reduce the drive to smoke, thereby reducing cravings for smoking after quit day, which are the main cause of early relapse. A prior systematic review showed inconclusive and heterogeneous evidence that preloading was effective and little evidence of the mechanism of action, with no cost-effectiveness data. Objectives To assess (1) the effectiveness, safety and tolerability of nicotine preloading in a routine NHS setting relative to usual care, (2) the mechanisms of the action of preloading and (3) the cost-effectiveness of preloading. Design Open-label randomised controlled trial with examination of mediation and a cost-effectiveness analysis. Setting NHS smoking cessation clinics. Participants People seeking help to stop smoking. Interventions Nicotine preloading comprised wearing a 21 mg/24 hour nicotine patch for 4 weeks prior to quit date. In addition, minimal behavioural support was provided to explain the intervention rationale and to support adherence. In the comparator group, participants received equivalent behavioural support. Randomisation was stratified by centre and concealed from investigators. Main outcome measures The primary outcome was 6-month prolonged abstinence assessed using the Russell Standard. The secondary outcomes were 4-week and 12-month abstinence. Adverse events (AEs) were assessed from baseline to 1 week after quit day. In a planned analysis, we adjusted for the use of varenicline (Champix ® ; Pfizer Inc., New York, NY, USA) as post-cessation medication. Cost-effectiveness analysis took a health-service perspective. The within-trial analysis assessed health-service costs during the 13 months of trial enrolment relative to the previous 6 months comparing trial arms. The base case was based on multiple imputation for missing cost data. We modelled long-term health outcomes of smoking-related diseases using the European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) model. Results In total, 1792 people were eligible and were enrolled in the study, with 893 randomised to the control group and 899 randomised to the intervention group. In the intervention group, 49 (5.5%) people discontinued preloading prematurely and most others used it daily. The primary outcome, biochemically validated 6-month abstinence, was achieved by 157 (17.5%) people in the intervention group and 129 (14.4%) people in the control group, a difference of 3.02 percentage points [95% confidence interval (CI) –0.37 to 6.41 percentage points; odds ratio (OR) 1.25, 95% CI 0.97 to 1.62; p = 0.081]. Adjusted for use of post-quit day varenicline, the OR was 1.34 (95% CI 1.03 to 1.73; p = 0.028). Secondary abstinence outcomes were similar. The OR for the occurrence of serious AEs was 1.12 (95% CI 0.42 to 3.03). Moderate-severity nausea occurred in an additional 4% of the preloading group compared with the control group. There was evidence that reduced urges to smoke and reduced smoke inhalation mediated the effect of preloading on abstinence. The incremental cost-effectiveness ratio at the 6-month follow-up for preloading relative to control was £710 (95% CI –£13,674 to £23,205), but preloading was dominant at 12 months and in the long term, with an 80% probability that it is cost saving. Limitations The open-label design could partially account for the mediation results. Outcome assessment could not be blinded but was biochemically verified. Conclusions Use of nicotine-patch preloading for 4 weeks prior to attempting to stop smoking can increase the proportion of people who stop successfully, but its benefit is undermined because it reduces the use of varenicline after preloading. If this latter effect could be overcome, then nicotine preloading appears to improve health and reduce health-service costs in the long term. Future work should determine how to ensure that people using nicotine preloading opt to use varenicline as cessation medication. Trial registration Current Controlled Trials ISRCTN33031001. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 41. See the NIHR Journals Library website for further project information.
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We evaluated the impact of intensive smoking cessation activities as an adjunct to anti-tuberculosis treatment on patient-related treatment outcomes. In this open-label, randomised controlled trial, self-reporting smokers with pulmonary tuberculosis who initiated standard anti-tuberculosis treatment were randomised to either nicotine replacement therapy and behaviour change counselling (n = 400) or counselling alone (n = 400) provided at baseline and two follow-up visits. The primary outcomes were change in TBscore at 24-weeks and culture conversion at 8-weeks. Biochemical smoking quit rates defined as serum cotinine levels <10 ng/mL and/or exhaled carbon monoxide levels <6 ppm (47·8% vs 32·4%, p-value =< 0·001) and self-reported quit rates (69.3% vs 38·7%, p-value =< 0·001) were significantly higher in the intervention arm at 24-weeks. Though the TBscores at 24 weeks (95% CI) were lower in the intervention arm [2·07 (1·98, 2·17) versus 2.12 (2·02, 2·21)], the difference was not clinically meaningful. Patients in the control arm required treatment extension more often than intervention arm (6·4% vs 2·6%, p-value = 0·02). Combining nicotine replacement therapy with behaviour change counselling resulted in significantly higher quit rates and lower cotinine levels, however, impact on patient-related (TBscore) or microbiological outcomes (culture conversion) were not seen.