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Design, Recruitment and Start Up of a Primary Care Weight Loss Trial Targeting African American and Hispanic Adults
Abstract
Primary care offices are critical access points for obesity treatment, but evidence for approaches that can be implemented within these settings is limited. The Think Health! (¡Vive Saludable!) Study was designed to assess the feasibility and effectiveness of a behavioral weight loss program, adapted from the Diabetes Prevention Program, for implementation in routine primary care. Recruitment of clinical sites targeted primary care practices serving African American and Hispanic adults. The randomized design compares (a) a moderate-intensity treatment consisting of primary care provider counseling plus additional counseling by an auxiliary staff member (i.e., lifestyle coach), with (b) a low-intensity, control treatment involving primary care provider counseling only. Treatment and follow up duration are 1 to 2 years. The primary outcome is weight change from baseline at 1 and 2 years post-randomization. Between November 2006 and January 2008, 14 primary care providers (13 physicians; 1 physician assistant) were recruited at five clinical sites. Patients were recruited between October 2007 and November 2008. A total of 412 patients were pre-screened, of whom 284 (68.9%) had baseline assessments and 261 were randomized, with the following characteristics: 65% African American; 16% Hispanic American; 84% female; mean (SD) age of 47.2 (11.7) years; mean (SD) BMI of 37.2(6.4) kg/m(2); 43.7% with high blood pressure; and 18.4% with diabetes. This study will provide insights into the potential utility of moderate-intensity lifestyle counseling delivered by motivated primary care clinicians and their staff. The study will have particular relevance to African Americans and women.
... The Think Health! study was designed to evaluate a moderate-intensity weight-management approach involving counseling by primary care clinicians (all physicians except for one physician's assistant) every 4 months supplemented with coaching by practice staff serving as lifestyle coaches (termed "Basic Plus") (3). Coaches provided counseling monthly for the first year, tapering to every other month in the second year. ...
... Think Health! was a parallel-group randomized controlled trial within primary care practices in Philadelphia, Pennsylvania. Key design and implementation elements are summarized here; detailed accounts are published elsewhere (3,7). The objective was to assess the feasibility and effectiveness of a moderateintensity lifestyle behavior-change program ("Basic Plus") compared with a lower-intensity version ("Basic"). ...
... Questionnaires (English or Spanish) were self-administered with staff assistance as needed (3). Weight-related dietary behaviors were assessed and scored based on a 30-item version of a longer questionnaire used in a study of black women (11). ...
Objective
Think Health! ¡Vive Saludable! evaluated a moderate‐intensity, lifestyle behavior‐change weight‐loss program in primary care over 2 years of treatment. Final analyses examined weight‐change trajectories by treatment group and attendance.
Methods
Adult primary care patients (n = 261; 84% female; 65% black; 16% Hispanic) were randomly assigned to Basic Plus (moderate intensity; counseling by primary care clinician and a lifestyle coach) or Basic (clinician counseling only). Intention‐to‐treat analyses used all available weight measurements from data collection, treatment, and routine clinical visits. Linear mixed‐effects regression models adjusted for treatment site, gender, and age, and sensitivity analyses evaluated treatment attendance and the impact of loss to follow‐up.
Results
Model‐based estimates for 24‐month mean (95% CI) weight change from baseline were −1.34 kg (−2.92 to 0.24) in Basic Plus and −1.16 kg (−2.70 to 0.37) in Basic (net difference −0.18 kg [−2.38 to 2.03]; P = 0.874). Larger initial weight loss in Basic Plus was attenuated by a ~0.5‐kg rebound at 12 to 16 months. Each additional coaching visit was associated with a 0.37‐kg greater estimated 24‐month weight loss (P = 0.01).
Conclusions
These findings in mostly black and Hispanic female primary care patients suggest that strategies to improve treatment attendance may improve weight loss resulting from moderate‐intensity counseling.
... The Think Health! Study assessed the feasibility and effectiveness of a lifestyle weight loss program designed for feasibility in primary care settings [2][3][4]. The counseling protocol was intended to approximate a moderate-intensity treatment approach (i.e., monthly visits) [5]. ...
... Lifestyle behavior change content was adapted from the Diabetes Prevention Program and provided in simplified, professionallyformatted patient materials [6,7]. Primary care practitioners (PCPs) and medical assistants or other internal practice staff served as "lifestyle coaches" (LCs) and received special training on how to use these materials to counsel individual patients over a 2-year period [2][3][4]. After the study ended, we obtained feedback from PCPs, LCs and clinic administrators about the feasibility and potential utility of the approach for ongoing adoption. ...
... The Think Health! Study design and findings have been reported elsewhere [2][3][4] The design was a randomized controlled trial in which patients recruited at each of 5 participating primary care practices were assigned at random to 1 of 2 treatment conditions. The "Basic" condition was a low-intensity version that did not include the LC counseling. ...
Rationale: Feasible approaches for providing obesity treatment in primary care settings have been difficult to identify. We assessed the views of primary care clinicians and practice staff about a simplified, lifestyle weight loss program after their participation in a randomized trial designed to evaluate the program within their clinical practices. Methods: Post-hoc interviews were conducted with 13 clinicians and 12 auxiliary staff at the 5 participating practices in the Think Health! Study of weight management in primary care. A 13-item survey was used to guide semi-structured interviews about the perceived strengths, weakness, and potential long-term utility of the program. Responses were analyzed using descriptive statistics and qualitative methods. Results: Providers unanimously endorsed the need for weight loss counseling for their patients. They supported the need for more frequent visits initially to best engage patients in a weight loss program. Additional training in counseling skills was desired. Conclusion: Clinicians participating in a practice- based trial valued having weight loss materials available to share with patients. Offering patient materials that convey key content and structure for behavior change tasks while allowing provider discretion in how materials are integrated into patient care might be a viable option for testing in future practice-based research.
... (3) The Think Health! Study used individual counseling delivered by primary care providers (PCPs) to patients recruited from within their own practices (18)(19)(20). Only data for the 169 black participants (from a total sample of 261) were considered in the pooled data set. ...
... Height and weight measurements were assessed with the same or similar equipment and comparable protocols across studies (16)(17)(18). Demographic, medical history, and behavioral characteristics were obtained by questionnaire, with each subsequent study using or adapting the case report forms used in the prior study or studies. Each study measured a "baseline weight" during screening before the start of interventions. ...
Objective
Differentiating trajectories of weight change and identifying associated baseline predictors can provide insights for improving behavioral obesity treatment outcomes.Methods
Secondary, observational analyses using growth mixture models were conducted in pooled data for 604 black American, primarily female adults in three completed clinical trials. Covariates of identified patterns were evaluated.ResultsThe best fitting model identified three patterns over 2 years: 1) mean weight loss of approximately 2 kg (n = 519); 2) mean weight loss of approximately 3 kg at 1 year, followed by ∼4 kg regain (n = 61); and 3) mean weight loss of ∼20 kg at 1 year followed by ∼4 kg regain (n = 24, with 23 from one study). In final multivariate analyses, higher BMI predicted having pattern 2 (OR [95% CI]) 1.10 [1.03, 1.17]) or 3 (OR [95% CI] 1.42 [1.25, 1.63]), and higher dietary fat score was predictive of a lower odds of having patterns 2 (OR [95% CI] 0.37[0.15, 0.94]) or 3 (OR [95% CI] 0.23 [0.07, 0.79]).Conclusions
Findings were consistent with moderate, clinically non-significant weight loss as the predominant pattern across all studies. Results underscore the need to develop novel and more carefully targeted and tailored approaches to facilitating weight loss in black American adults.
... A detailed description of the Think Health! design, recruitment and start up has been published (17). Briefly, clinical sites were five primary care practices in the Philadelphia, Pennsylvania area, recruited between November 2006 and January 2008. ...
... To accommodate participant interests and to account for missed visits, LC's were permitted to address more than one topic at a given session, rather than necessarily one session per month in sequential order. data collection Data collection procedures have been described (17). Research staff obtained baseline measurements and questionnaire data on demographic and personal characteristics during eligibility determination at the patient' s primary care practice site. ...
The Think Health! study evaluated a behavioral weight loss program adapted from the Diabetes Prevention Program (DPP) lifestyle intervention to assist primary care providers (PCPs) and auxiliary staff acting as lifestyle coaches (LCs) in offering weight loss counseling to their patients. In a randomized trial conducted at five clinical sites, study participants were randomly assigned in a 1:1 ratio within each site to either "Basic Plus" (n = 137), which offered PCP counseling every 4 months plus monthly LC visits during the first year of treatment, or "Basic" (n = 124), which offered only PCP counseling every 4 months. Participants were primarily (84%) female, 65% African American, 16% Hispanic American, and 19% white. In the 72% of participants in each treatment group with a 12-month weight measurement, mean (95% CI) 1-year weight changes (kg) were -1.61 (-2.68, -0.53) in Basic Plus and -0.62 (-1.45, 0.20) in Basic (difference: 0.98 (-0.36, 2.33); P = 0.15). Results were similar in model-based estimates using all available weight data for randomized participants, adjusting for potential confounders. More Basic Plus (22.5%) than Basic (10.2%) participants lost ≥ 5% of their baseline weight (P = 0.022). In a descriptive, nonrandomized analysis that also considered incomplete visit attendance, mean weight change was -3.3 kg in Basic Plus participants who attended ≥ 5 LC visits vs. + 0.53 kg in those attending <5 LC visits. We conclude that the Basic Plus approach of moderate-intensity counseling by PCPs and their staff can facilitate modest weight loss, with clinically significant weight loss in high program attenders.
... Still another study found no augmentation of weight loss when motivational interviewing was added to a culturally-targeted behavioral program, although the sample size was small [20]. Three other studies [21,22,23], two of which are ongoing [21,23], have taken place in primary care settings, and a number of non-randomized studies have been conducted in African American churches [24,25]. ...
... Still another study found no augmentation of weight loss when motivational interviewing was added to a culturally-targeted behavioral program, although the sample size was small [20]. Three other studies [21,22,23], two of which are ongoing [21,23], have taken place in primary care settings, and a number of non-randomized studies have been conducted in African American churches [24,25]. ...
Lower socioeconomic status at both the individual and neighborhood level is associated with increased health risks. Weight loss can reduce this risk, but few high quality weight-loss studies target this population.
STARS tests a culturally appropriate, group-based behavioral and social support intervention on body weight and waist circumference in women from financially disadvantaged neighborhoods.
A stratified (by BMI) randomized trial. Randomization to group was generated by a random numbers table with allocation concealment by opaque envelopes.
Participants 25-50 years who had a BMI ≥ 25 kg/m(2) and a waist circumference ≥ 88 cm were recruited from 18 census tracts in Columbia, SC with high rates of poverty between November 2008 and November 2010. All participants received a dietary and exercise counseling session. Intervention participants then receive 16 theoretically-based and tailored weekly group sessions followed by 8 weeks of telephone maintenance counseling. Control participants receive 16 weekly health education mailings. Measurements correspond to baseline, post-group intervention, and post-telephone counseling, and for intervention participants, after a 12-week no-contact period. Measurement staff was blinded to group assignment.
Participants (N=155; n=80 intervention, n=75 minimal intervention control) were primarily African American (86.5%) and averaged 38.9 years with a mean BMI of 40.1 kg/m(2) and waist circumference of 115.4 cm. Food insecurity was reported by 43% of participants.
STARS targets an underserved population with an innovative, tailored, and theoretically-grounded, group-based intervention followed by telephone maintenance. If effective, the approach has the potential to be feasible and cost-effective for community delivery.
... In this study, participants selected a friend or family member, or were assigned a partner to work with to set and attain health goals. Other dyadic studies have paired family members (Jackson et al., 2015;Sorkin et al., 2014), strangers, and friends (Kumanyika et al., 2011); to promote weight loss. Best practices for how to match dyad partners within African American faith communities has not been explored in the literature. ...
This study examined how African American church members communicated and cooperated as dyads to attain health goals. Participants completed nine weeks of group classes then worked as dyads for nine weeks. Communication logs and interviews were used to assess: (1) dyad communication and (2) dyad cooperation. Thirty-two dyads from three churches completed the study. Dyads communicated an average of two times per week. Dyads experienced challenges and provided encouragement. Findings indicate African American church members cooperate and communicate as family, friend, and acquaintance dyads to achieve health goals.
... Çalışmamızda hastaların %79,8'inde kronik hastalık öyküsü vardı. Literatürle uyumlu olarak en sık eşlik eden hastalıklar diyabet ve hipertansiyondu.[8][9][10][11][12][13] fiziksel aktivite ile 12 aylık sürede %3'ten az kilo kaybı sağlanırken 15 ; diyet ve fiziksel aktivite ile bu oran %6'ya çıkmaktadır.16 ...
INTRODUCTION: The aim of this study was to evaluate the annual weight loss rate and the number of visits to obesity follow-up and to provide more effective follow-up of the patients with obesity follow-up. METHODS: In this retrospective study, there is no history of additional metabolic disease or drug use in obesity followed by at least one year in Obesity Outpatient Clinic of Istanbul Medeniyet University, Göztepe Training and Research Hospital. Patients over 18 years of age with a body mass index (BMI) of ≥30 mg/m2 were included in the study. The annual weight loss rates were calculated by calculating the results of an annual weight gain. RESULTS: The average annual weight loss in 243 patients was 6.9 +- 5.9 kg, and the average annual weight loss rate was 7.12 +- 5.75%. At the end of a year follow-up, 63.4% of the patients lost 5% weight with lifestyle intervention. A cut off value of 11 was found to be significant for the number of visits with a 5% weight loss. There was a statistically significant relationship between the annual weight loss rate and the number of visits. DISCUSSION AND CONCLUSION: Lifestyle intervention is a very effective and applicable method in the treatment of obesity. Since this treatment is a feasible method in the primary care unit, as the number of visits increases, the success rate of treatment increases and the strategies to be included in the first step should be determined.
... Weight loss in the intervention group was greater than the weight loss observed in other primary care studies [15,19,26,27] but smaller than the weight loss observed by Wadden et al. in the first year of the study [20]. Nevertheless, an important difference was that, unlike the Wadden study, the loss recorded in our study was maintained in the second year. ...
Background
Overweight and obesity are common health problems which increase the risk of developing several serious health conditions. The main difficulty in the management of weight-loss lies in its maintenance, once it is achieved. The aim of this study was to investigate whether a motivational intervention, together with current clinical practice, was more efficient than a traditional intervention, in the treatment of overweight and obesity and whether this intervention reduces cardiovascular risk factors associated with overweight and obesity.
Methods
Multi-centre cluster randomized trial with a 24-month follow-up included 864 overweight/obese patients randomly assigned. Motivational intervention group (400 patients), delivered by a nurse trained by an expert psychologist, in 32 sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard programmed diet and exercise. The control group (446 patients), received the usual follow-up.
Results
Weight reduction was statistically significant in the second year with a mean reduction of 1.0 Kg in the control group and 2.5 Kg in the intervention group (p = 0. 02). While 18.1% of patients in the control group reduced their weight by more than 5%, this percentage rose to 26.9% in the intervention group, which is statistically significant (p = 0.04). Patients in the motivational intervention group had significantly greater improvements in triglycerides and APOB/APOA1ratio.
Conclusions
The results highlight the importance of the group motivational interview in the treatment of overweight /obese patients in primary care, and in the improvement of their associated cardiovascular risks factors.
Trial registration
ClinicalTrials.gov Identifier: NCT01006213 October 30, 2009.
Electronic supplementary material
The online version of this article (doi:10.1186/s12875-017-0644-y) contains supplementary material, which is available to authorized users.
... POWR-UP enrolled an all-female population because women have higher obesity rates and more pronounced functional frailty than men. We oversampled black women because they have the highest obesity rates of any demographic subgroup and yet are understudied with regard to the most effective obesity interventions (3,24,25). Participants aged $45 y were included because the precise timing of changes in the protein response with age has not been established. For example, the age at which the anabolic resistance of aging begins to take a clinically detectable toll on function is unknown (26). ...
Background
Women have higher rates of obesity than men and develop more pronounced functional deficits as a result. Yet, little is known about how obesity reduction affects their functional status, including whether their responses differ when protein intake is enhanced.
Objective
The aim of this study was to confirm the feasibility of delivery of a higher-protein (balanced at each meal) calorie-restricted diet in obese women and determine its efficacy for influencing function and retention of lean mass.
Method
Obese community-dwelling women [n = 80; body mass index (in kg/m²), in means ± SDs: 37.8 ± 5.9; aged 45–78 y; 58.8% white] were enrolled in a weight-loss (−500 kcal/d) study and randomly assigned to either a Control–Weight-Loss (C-WL; 0.8 g protein/kg body weight) group or a High-Protein–Weight-Loss (HP-WL; 1.2 g protein/kg body weight; 30 g protein 3 times/d) group in a 1:2 allocation. Primary outcomes were function by 6-min walk test (6MWT) and lean mass by using the BodPod (Life Measurement, Inc.) at 0, 4, and 6 mo.
Results
Both groups reduced calorie intakes and body weights (P < 0.001), and the feasibility of the HP-WL intervention was confirmed. The 6MWT results improved (P < 0.01) at 4 mo in the HP-WL group and at 6 mo in both groups (P < 0.001). Both groups improved function by several other measures while slightly decreasing (P < 0.01) lean mass (−1.0 kg, C-WL; −0.6 kg, HP-WL). Weight loss was greater in white than in black women at both 4 mo (6.0 ± 3.6 compared with 3.7 ± 3.4 kg; P < 0.02) and 6 mo (7.2 ± 4.8 compared with 4.0 ± 4.7 kg; P < 0.04) and tended to be positively related to age (P < 0.06).
Conclusions
A clinically important functional benefit of obesity reduction was confirmed in both study groups, with no significant group effect. Our findings of racial differences in response to the intervention and a potential influence of participant age lend support for further studies sufficiently powered to explore the interaction of race and age with functional responses to obesity reduction in women. This trial was registered at clinicaltrials.gov as NCT02033655.
... To prevent functional losses after surgery, clinicians should emphasize healthy weight maintenance or weight loss for Black women who are at high risk for uterine cancer, especially for those with a BMI of >40. Prescriptions for exercise, physician-led counseling [39], and expanded insurance coverage for fitness facilities could be integrated into primary care and oncology practice to assist in weight loss and maintenance across the health and disease continuum. Recent advancements in this area have shown that one-on-one physician-led counseling combined with telemedicine and text messaging-based weight loss techniques can produce significant weight loss for endometrial cancer patients [40]. ...
Purpose:
Racial disparities in uterine cancer-related outcomes have been reported. The goal of this study was to determine if race, pre-operative body mass index (BMI), and medical comorbidities are predictors of loss of functional independence after hysterectomy for uterine cancer.
Methods:
Loss of independence was defined as a change from pre-operative functional independence, to a post-operative requirement of discharge to a post-care facility, or death within the first 30 days following uterine cancer surgery. Demographic factors, comorbidities, BMI, intra-operative and post-operative outcomes, and discharge status were abstracted from the 2011 and 2012 American College of Surgeons National Surgical Quality Improvement Program (NSQIP). Statistical analyses included multivariable logistic regression and Wald tests for interaction.
Results:
A total of 4005 patients had uterine cancer and were functionally independent pre-operatively. After adjusting for clinical features and comorbidities, Black women were not significantly more likely to lose functional independence than non-Black women. However, a significant interaction (OR = 1.17, p < 0.001) was found between race and BMI for loss of functional independence. Interaction plots revealed worsening functional outcomes for Black women with BMI >40 but not in non-Blacks.
Conclusions:
The interaction suggests a 17 % increased odds of losing independence for each unit of BMI difference for Black uterine cancer patients, or 170 % increased odds of losing independence for a 10-point increase in BMI, given a linear association. To reduce the likelihood of losing post-operative functional independence, Black, high-BMI patients with or at risk for uterine cancer may especially benefit from weight loss or interventions to optimize physical function.
... To our knowledge, this is the first randomized clinical trial to evaluate the effectiveness of lifestyle modification in reducing weight in a low-income minority sample (84 % Hispanics, 11 % African Americans) with the metabolic syndrome. There have been previous efforts, however, to use structured interventions, such as the DPP, for ethnic minorities in less controlled settings, including primary care practices and communities (Cox et al., 2013;Kumanyika et al., 2009Kumanyika et al., , 2011Ruggiero et al., 2011). Among African American adults, for example, a recent review demonstrated the suboptimal effectiveness of the DPP intervention, particularly for women, signaling the need for enhancement to existing-based interventions (Samuel-Hodge et al., 2014). ...
Although weight is an important intervention target among patients with metabolic syndrome, few trials have recruited low-income minority populations. The Community Health and Risk-reduction for Metabolic Syndrome randomized controlled trial aimed to examine the effects of a lifestyle intervention on weight and metabolic syndrome components among low-income minority adults. We randomized 120 adults with metabolic syndrome to standard medical care (N = 60) or a lifestyle intervention (N = 60). Using an intent-to-treat approach, we found significant intervention effects on weight [B = -0.452; SE = 0.122; 95 % confidence intervals (CI) -0.653 to -0.251) and glucose levels at 6-months (B = -0.522, SE = 0.234, 95 % CI -0.907 to -0.138). These changes were maintained through the 12-month assessment. No significant effects were observed on insulin resistance or other metabolic syndrome components. Our intervention was successful in achieving modest but significant weight loss and reduction in fasting glucose among low-income minority subjects with metabolic syndrome.
... One study [47] recruited participants from online advertisement, seeking individuals with a self-reported clinical diagnosis of prediabetes occurring within the past year; however, recruitment was based on selfselection by participants, which does not reflect a truly random sample [47]. Three studies were scored as having 'moderate' participation, where 63 % [48], 57 % [49], and 44 % [50] of the individuals were enrolled after assessing all 'invited' individuals, for study eligibility (see Table 3 and Additional file 2: Table S6). In most of the remaining studies, the 'low' participation was attributed to either the non-eligibility of potential participants or the refusal to participate. ...
Background:
The evidence base for the prevention of type 2 diabetes mellitus (T2DM) has progressed rapidly from efficacy trials to real-world translational studies and practical implementation trials over the last 15 years. However, evidence for the effective implementation and translation of diabetes programs and their population impact needs to be established in ways that are different from measuring program effectiveness. We report the findings of a systematic review that focuses on identifying the critical success factors for implementing diabetes prevention programs in real-world settings.
Methods:
A systematic review of programs aimed at diabetes prevention was undertaken in order to evaluate their outcomes using the penetration, implementation, participation, and effectiveness (PIPE) impact metric. A search for relevant articles was carried out using PubMed (March 2015) and Web of Science, MEDLINE, CENTRAL, and EMBASE. A quality coding system was developed and included studies were rated independently by three researchers.
Results:
Thirty eight studies were included in the review. Almost all (92 %) provided details on participation; however, only 18 % reported the coverage of their target population (penetration). Program intensity or implementation-as measured by frequency of contacts during first year and intervention duration-was identified in all of the reported studies, and 84 % of the studies also reported implementation fidelity; however, only 18 % of studies employed quality assurance measures to assess the extent to which the program was delivered as planned. Sixteen and 26 % of studies reported 'highly' or 'moderately' positive changes (effectiveness) respectively, based on weight loss. Six (16 %) studies reported 'high' diabetes risk reduction but 'low' to 'moderate' weight loss only.
Conclusion:
Our findings identify that program intensity plays a major role in weight loss outcomes. However, programs that have high uptake-both in terms of good coverage of invitees and their willingness to accept the invitation-can still have considerable impact in lowering diabetes risk in a population, even with a low intensity intervention that only leads to low or moderate weight loss. From a public health perspective, this is an important finding, especially for resource constrained settings. More use of the PIPE framework components will facilitate increased uptake of T2DM prevention programs around the world.
Background
Prediabetes is a global health concern, the American Diabetes Association (ADA) guidelines for prediabetes was adopted worldwide, however, implementing these guidelines and their outcomes vary based on regions and ethnic backgrounds. This study aims to address the gap in research regarding the management efficiency of prediabetic patients in a hospital in Vietnam.
Method
The study included 418 prediabetic patients who visited Vinmec Times City Hospital in Vietnam from June 2020 to June 2022. The data was collected from detailed medical records to describe the characteristics of prediabetic patients and evaluate the management effectiveness of these patients.
Results
The average age of the participants was 53 years, with a balanced sex distribution. The mean BMI of our population was 24.4 kg/m². Dyslipidemia was significantly common (92.7%), other comorbidities and complications had lower rates. Weight loss was challenging with 10.5% achieved 5% weight loss. 7.6% developed diabetes in one year and the same number achieved remission. Lipid panel improved significantly, still, only 18.5% achieved Low-density lipoprotein (LDL-C) goal. Baseline high fasting blood glucose (FBG) and HbA1C were associated with a higher risk of developing diabetes.
Conclusion
This study provides insights into the characteristics of prediabetic patients and the effectiveness of their management at Vinmec Times City Hospital in Vietnam. It highlights the need for a well-designed lifestyle change program and enhanced dyslipidemia management.
As obesity prevalence continues to rise, approximately one third of patients seen by Australian general practitioners (GPs) are living with obesity. General practice is the cornerstone of primary care in Australia with 85% of the population seeing a GP at least annually. The current role of the GP in obesity management focuses on care co-ordination with guidelines encouraging the referral of patients to allied health services, including dietitians and exercise physiologists. But multidisciplinary team care is not always available due to factors such as location and cost, or patients may have a preference for working more closely with their GP. Currently there are no weight management programs where care is delivered by a GP. This doctoral work explores the current role of the GP in obesity management in Australia, outlines an intervention development study for a GPdelivered weight management program, and presents the findings of a feasibility trial of the program. Following the UK Medical Research Council’s Guidelines for the Development of a Complex Intervention, a GP-delivered weight management program was developed. The draft program was based on Australian evidence-based guidelines for obesity management and used a qualitative approach to engage stakeholders to refine the program materials. Following this intervention development, a six-month feasibility trial was undertaken in five general practices involving 11 GPs and 23 patients. Guided by Normalisation Process Theory, both quantitative and qualitative data were collected. Both GPs and patients reported high rates of acceptability and feasibility, and there was a low dropout rate with only three patients withdrawing. Based on the theoretical framework of Bordin, patients and GPs with a strong therapeutic alliance had better program retention and there was a trend to improvement in some health outcomes. Social cognitive theory suggests that “performance mastery” is the most effective way to develop self-efficacy. This was demonstrated in the feasibility trial with both qualitative and quantitative data showing the GPs improved self-efficacy for obesity management. Based on the findings in the feasibility trial, a modified approach to obesity management in primary care is suggested with a greater emphasis on therapeutic relationship, person-centredness, and the explicit recognition that care occurs over time and not within one consultation. A GP-delivered weight management program in Australia was demonstrated to be feasible and acceptable to both patients and their GPs. Future research will focus on a pseudo-cluster randomised controlled trial for effectiveness, alongside further development of a measure for therapeutic alliance in general practice for research, teaching, and clinical purposes.
Primary care offers a familiar and accessible clinical venue for patients with obesity to receive evidence-based lifestyle interventions for weight management. However, there are numerous barriers to the implementation of such programs in primary care, and previous primary care weight loss interventions demonstrate modest and temporary effects. Weight loss treatment delivered within primary care by peer coaches may offer a viable and effective alternative. The purpose of this trial is to test the effects of weight loss treatment that includes ongoing support from a peer coach (i.e., trained, salaried community health workers) as compared to self-directed treatment. Peer coach treatment will be delivered over 18 months and includes a combination of in-person, group-based office visits and individual telephone contacts. This weight loss trial will include 375 adults with obesity (BMI = 30-50 kg/m2) randomized from 10 primary care practices. The primary outcome will be changes in body weight at month 18. Secondary outcomes will include key patient-centered outcomes, including quality-of-life, physical and social functioning, mood, and treatment satisfaction. The cost-effectiveness of the peer coach intervention will also be evaluated. If this novel intervention is effective, it could offer a practical and sustainable approach for the delivery of weight loss treatment in primary care that has the potential to improve clinical outcomes for patients, increase treatment options for primary care providers, and reduce obesity-related healthcare utilization and costs.
Objectives
Obesity management is an important issue for the international primary care community. This scoping review examines the literature describing the role of the family doctor in managing adults with obesity. The methods were prospectively published and followed Joanna Briggs Institute methodology.
Setting
Primary care. Adult patients.
Included papers
Peer-reviewed and grey literature with the keywords obesity, primary care and family doctors. All literature published up to September 2015. 3294 non-duplicate papers were identified and 225 articles included after full-text review.
Primary and secondary outcome measures
Data were extracted on the family doctors’ involvement in different aspects of management, and whether whole person and person-centred care were explicitly mentioned.
Results
110 papers described interventions in primary care and family doctors were always involved in diagnosing obesity and often in recruitment of participants. A clear description of the provider involved in an intervention was often lacking. It was difficult to determine if interventions took account of whole person and person-centredness. Most opinion papers and clinical overviews described an extensive role for the family doctor in management; in contrast, research on current practices depicted obesity as undermanaged by family doctors. International guidelines varied in their description of the role of the family doctor with a more extensive role suggested by guidelines from family medicine organisations.
Conclusions
There is a disconnect between how family doctors are involved in primary care interventions, the message in clinical overviews and opinion papers, and observed current practice of family doctors. The role of family doctors in international guidelines for obesity may reflect the strength of primary care in the originating health system. Reporting of primary care interventions could be improved by enhanced descriptions of the providers involved and explanation of how the pillars of primary care are used in intervention development.
Objective. To examine existing system-, clinic-, provider-, and individual- level interventions to improve culturally appropriate health care for people with disabilities; lesbian, gay, bisexual, and transgender (LGBT) populations; and racial/ethnic minority populations.
Data sources. Ovid MEDLINE®, PsycINFO®, Ovid Embase®, and the Cochrane EPOC (Effective Practice and Organisation of Care) register; hand searches of references of relevant studies.
Review methods. Two investigators screened abstracts and full-text articles of identified references for eligibility. Eligible studies included randomized controlled trials (RCTs), prospective cohort studies, and other observational studies with comparators that evaluated cultural competence interventions aimed at reducing health disparities in the formal health care system. Two investigators abstracted data and assessed risk of bias. Given the sparse and patchy literature, which precluded pooling, a qualitative analysis is provided.
Results. Over 37,000 nonduplicated English- language citations were reviewed; 56 unique studies were identified as of June 2015: 20 randomized controlled trials (RCTs) and 5 observational studies for individuals with disabilities; 5 RCTs (6 manuscripts) and 6 observational studies for LGBT populations; and 14 RCTs (15 manuscripts), 4 observational studies, and 2 systematic reviews for members of racial and ethnic minorities. Interventions fell into four broad categories: (1) provider trainings and education; (2) interventions providing alteration of an established protocol, or the delivery of an established protocol, to meet the needs of a target population; (3) interventions prompting patients to interact with the formal health care system or health care providers; and (4) interventions aimed at providing
culturally competent care at the point of service.
Educational programs and trainings to improve professional students’ and providers’ cultural competence behavior are the most prevalent type of cultural competence intervention. Two existing high-quality systematic reviews of provider educational interventions for racial/ethnic minority populations found low-strength evidence that cultural competence training had mixed effects for intermediate outcomes and no effect on treatment outcomes. Sixteen studies aimed at changing provider attitudes and beliefs through training or curriculums were identified for the disability population. Eleven of these studies focused on reducing professional stigma toward people with serious or chronic mental illness; five focused on changing professional attitudes and beliefs about people with physical or intellectual disability. Three educational interventions were identified for the LGBT population. Several
short-term effects were evaluated; however, long- term effects of provider training on provider cultural competence behavior in the clinical setting and subsequent patient health outcomes have not been evaluated for the disability and LGBT populations. Two included studies reported a potential harm from provider training: an increase in negative attitudes or stigma resulting from intervention.
Interventions providing alterations of an established protocol were concentrated in the populations. The 12 studies of culturally tailored health care interventions for racial/ethnic minority populations focused primarily on treatment of chronic physical or
mental health conditions (e.g., diabetes, depression, substance abuse). Two psychological interventions were also tailored for members of the LGBT population.
Another common type of intervention was to provide additional resources to encourage or empower patients to interact with the formal health care system and/or health care providers. The stated aims of these types of interventions were to increase receipt of screenings for which disparities are well documented (e.g., Pap tests for people with mobility impairments or colorectal cancer screening among Latino immigrants) or to help patients engage in medical decisionmaking. These studies met inclusion criteria if the intervention was conducted by a medical professional in a formal health care system. One potential limitation of
these types of interventions is that they rely on strong identification with a common
culture. The population groups highlighted in this review are large and diverse. Creating an intervention for “African Americans” or “women who have sex with women” may be differentially effective for specific subpopulations.
The most common culturally competent point-of-service interventions were documents, similar to a hand-held medical record, that patients carried to their appointments to prompt providers to evaluate areas of known disparity for a specific population. These interventions may be coupled with provider notices or trainings. Virtual interventions were also considered culturally competent point-of-service interventions for some people with disabilities, as they create access in a unique way. These interventions are seen as conceptually parallel to infrastructure changes that improve access for people with physical disabilities.
For the majority of included studies, the risk of bias was high. The most common
methodological problems were lack of randomization to treatment, lack of attention control, little or no followup, and failure to report unintended consequences. Large segments of vulnerable or disadvantaged populations—such as children with disabilities; people who are gender nonconforming or transgender; or numerous racial or ethnic groups, including Native Americans or Alaskan Natives—remain essentially invisible in the cultural competence literature. The issue is compounded for people who are members of more than one priority population.
Conclusions. None of the included studies measured the effect of cultural competence interventions on health care disparities. Most of the training interventions measured changes in professional attitudes toward the population of interest but did not measure the downstream effect of changing provider beliefs on the care delivered to patients. Interventions that altered existing protocols, empowered patients to interact with the formal health care system, or prompted provider behavior at the point of care were more likely to measure patient-centered outcomes. The medium or high risk of bias of the included studies, the heterogeneity of populations, and the lack of measurement consensus prohibited pooling estimates or commenting about efficacy in a meaningful or responsible way. The term “cultural competence” is not well defined for the LGBT and disability populations, and is often
conflated with patient-centered or individualized care. There are many gaps in the
literature; many large subpopulations are not represented.
Prior research and systematic reviews have examined strategies related to weight management, less is known about lifestyle and behavioral counseling interventions optimally suited for implementation in primary care practices generally, and among racial and ethnic patient populations. Primary care practitioners may find it difficult to access and use available research findings on effective behavioral and lifestyle counseling strategies and to assess their effects health behaviors among their patients. This systematic review compiled existing evidence from randomized trials to inform primary care providers about which lifestyle and behavioral change interventions are shown to be effective for changing patients' diet, physical activity and weight outcomes.
The significantly higher breast cancer (BCa) mortality rates of African-American (AA) women compared to non-Hispanic (NHW) white women constitute a major US health disparity. Investigations have primarily focused on biological differences in tumors to explain more aggressive forms of BCa in AA women. The biology of tumors cannot be modified, yet lifestyle changes can mitigate their progression and recurrence. AA communities have higher percentages of obesity than NHWs and exhibit inefficient access to care, low socioeconomic status, and reduced education levels. Such factors are associated with limited healthy food options and sedentary activity. AA women have the highest prevalence of obesity than any other racial/ethnic/gender group in the United States. The social ecological model (SEM) is a conceptual framework on which interventions could be developed to reduce obesity. The SEM includes intrapersonal factors, interpersonal factors, organizational relationships, and community/institutional policies that are more effective in behavior modification than isolation from the participants’ environmental context. Implementation of SEM-based interventions in AA communities could positively modify lifestyle behaviors, which could also serve as a powerful tool in reducing risk of BCa, BCa progression, and BCa recurrence in populations of AA women.
Background
Efforts to recruit and retain participants in clinical trials are challenging, especially in studies that include minority or low-income children. To date, no studies have systematically examined recruitment and retention strategies and their effectiveness in working successfully with this population. We examined strategies employed to recruit or retain minority or low-income children in trials that included an obesity-related behavior modification component.
Methods
First, completed home-, community-, and school-based trials involving minority or low-income children aged 2–17 years were identified in a search of the ClinicalTrials.gov registry. Second, a PubMed search of identified trials was conducted to locate publications pertinent to identified trials. Recruitment and retention rates were calculated for studies that included relevant information.
Results
Our final analytic sample included 43 studies. Of these, 25 studies reported recruitment or retention strategies, with the amount of information varying from a single comment to several pages; 4 published no specific information on recruitment or retention; and 14 had no publications listed in PubMed. The vast majority (92 %) of the 25 studies reported retention rates of, on average, 86 %. Retention rates were lower in studies that: targeted solely Hispanics or African Americans (vs. mixed races of African Americans, whites, and others); involved children and parents (vs. children only); focused on overweight or obese children (vs. general children), lasted ≥1 year (vs. <1 year), were home or community-based (vs. school-based), included nutrition and physical activity intervention (vs. either intervention alone), had body mass index or other anthropometrics as primary outcome measures (vs. obesity-related behavior, insulin sensitivity, etc.). Retention rates did not vary based on child age, number of intervention sessions, or sample size.
Conclusions
Variable amounts of information were provided on recruitment and retention strategies in obesity-related trials involving minority or low-income children. Although reported retention rates were fairly high, a lack of reporting limited the available information. More and consistent reporting and systematic cataloging of recruitment and retention methods are needed. In addition, qualitative and quantitative studies to inform evidence-based decisions in the selection of effective recruitment and retention strategies for trials including minority or low-income children are warranted.
The increasing prevalence of obesity together with projected increases in diabetes over the next 20-30 years will put a substantial strain on the finances and resources of the US healthcare system. The best opportunity for broad scale treatment of obesity may lie in the primary care setting. This review assesses the evidence on the efficacy of treatment for obesity delivered in primary care in the United States. It summarizes an earlier systematic review, recent obesity treatment guidelines, and subsequent US based trials with a minimum follow-up of six months in which at least one member of a primary care team helped deliver comprehensive behavioral obesity treatment to adults with overweight or obesity. Overall, the evidence suggests that obesity treatment delivered in primary care has limited effectiveness. Questions remain about the optimal role of the primary care provider in the treatment of obesity and the prevention of weight gain, as well as potential systems approaches to the treatment of obesity.
© BMJ Publishing Group Ltd 2015.
The Diabetes Prevention Program (DPP) demonstrated risk reduction for incident diabetes through weight loss among all participants, including African Americans. Several DPP translations have been conducted in less controlled settings, including primary care practices and communities; however, there is no detailed compilation of how effective these translations have been for African Americans. This systematic literature review evaluated DPP translations from 2003 to 2012. Eligible records were retrieved using a search strategy of relevant databases and gray literature. Retrieved records (n = 1,272) were screened using a priori criteria, which resulted in 21 full-text studies for review. Seventeen studies were included in the full-text qualitative synthesis. Seven studies had 100% African American samples and 10 studies had mixed samples with African American subgroups. African American participants’ average weight loss was roughly half of that achieved in the DPP intervention. However, with few higher-quality studies, small sample sizes and differences in intervention designs and implementation, comparisons across interventions were difficult. The suboptimal effectiveness of DPP translations among African American adults, particularly women, signals the need for enhancements to existing evidence-based interventions and more high-quality research that includes other at-risk African American subgroups such as men and younger adults of lower socioeconomic status.
Recruitment of community-based youth into studies is challenging. We examined access issues, minority status, and personal costs of participation for a study of children with aggressive behaviors, designed to identify which ones are at risk for future violent behaviors, to identify protective factors, and to test interventions to reduce aggression. Of 1,038 contacts, 112 declined, 239 could not be re-contacted, and 124 were ineligible. Three hundred and fifty of 563 scheduled child-parent dyads completed intake assessment. Most were recruited through targeted mailings (33%) and community flyers (22%), 12% through regional news advertisement, 8% by Craigslist, and 5% through healthcare providers/clinics. Factors contributing to enrollment rates by zip code showed the percentage of Black residents per zip code and targeted mailings positively contributed (Beta = .200 & .419, respectively) and estimated transit travel time negatively contributed (Beta =.299) to enrollment rates (R2 = 0.562). Targeted mailings proved to be the most efficient strategy in successful recruitment.
Obesity is a global public health threat. The transtheoretical stages of change (TTM SOC) model has long been considered a useful interventional approach in lifestyle modification programmes, but its effectiveness in producing sustainable weight loss in overweight and obese individuals has been found to vary considerably. OBJECTIVES: To assess the effectiveness of dietary intervention or physical activity interventions, or both, and other interventions based on the transtheoretical model (TTM) stages of change (SOC) to produce sustainable (one year and longer) weight loss in overweight and obese adults.
Studies were obtained from searches of multiple electronic bibliographic databases. We searched The Cochrane Library, MEDLINE, EMBASE and PsycINFO. The date of the last search, for all databases, was 17 December 2013.
Trials were included if they fulfilled the criteria of randomised controlled clinical trials (RCTs) using the TTM SOC as a model, that is a theoretical framework or guideline in designing lifestyle modification strategies, mainly dietary and physical activity interventions, versus a comparison intervention of usual care; one of the outcome measures of the study was weight loss, measured as change in weight or body mass index (BMI); participants were overweight or obese adults only; and the intervention was delivered by healthcare professionals or trained lay people at the hospital and community level, including at home.
Two review authors independently extracted the data, assessed studies for risk of bias and evaluated overall study quality according to GRADE (Grading of Recommendations Assessment, Development and Evaluation). We resolved disagreements by discussion or consultation with a third party. A narrative, descriptive analysis was conducted for the systematic review.
A total of three studies met the inclusion criteria, allocating 2971 participants to the intervention and control groups. The total number of participants randomised to the intervention groups was 1467, whilst 1504 were randomised to the control groups. The length of intervention was 9, 12 and 24 months in the different trials. The use of TTM SOC in combination with diet or physical activity, or both, and other interventions in the included studies produced inconclusive evidence that TTM SOC interventions led to sustained weight loss (the mean difference between intervention and control groups varied from 2.1 kg to 0.2 kg at 24 months; 2971 participants; 3 trials; low quality evidence). Following application of TTM SOC there were improvements in physical activity and dietary habits, such as increased exercise duration and frequency, reduced dietary fat intake and increased fruit and vegetable consumption (very low quality evidence). Weight gain was reported as an adverse event in one of the included trials. None of the trials reported health-related quality of life, morbidity, or economic costs as outcomes. The small number of studies and their variable methodological quality limit the applicability of the findings to clinical practice. The main limitations include inadequate reporting of outcomes and the methods for allocation, randomisation and blinding; extensive use of self-reported measures to estimate the effects of interventions on a number of outcomes, including weight loss, dietary consumption and physical activity levels; and insufficient assessment of sustainability due to lack of post-intervention assessments.
The evidence to support the use of TTM SOC in weight loss interventions is limited by risk of bias and imprecision, not allowing firm conclusions to be drawn. When combined with diet or physical activity, or both, and other interventions we found very low quality evidence that it might lead to better dietary and physical activity habits. This systematic review highlights the need for well-designed RCTs that apply the principles of the TTM SOC appropriately to produce conclusive evidence about the effect of TTM SOC lifestyle interventions on weight loss and other health outcomes.
Health coaching is an effective strategy for improving cardiovascular disease risk factors. Coaching interventions have primarily been studied in Caucasians, and the effectiveness in other ethnic groups is not known. Further, adaptation of coaching to include culturally specific components has not been studied. Our aim is to describe a culturally specific coaching program targeted at reducing cardiovascular disease risk in South Asians. Participants initially underwent comprehensive cardiovascular disease risk screening, then received individualized risk assessment and behavioral recommendations. A health coach then contacted participants regularly for one year to provide encouragement with behavior change, troubleshoot challenges, and assess adherence. In the first five years of the program, 3,180 people underwent risk assessment, 3,132 were candidates for coaching, 2,726 indicated a desire to participate in coaching, 1,359 received coaching, and 1,051 completed coaching for at least one year. Culturally specific health coaching is an appealing and feasible intervention for reducing cardiovascular disease risk in South Asians, with very low attrition. Coaching strategies for risk reduction are proven to be effective, but further longitudinal research is needed to determine whether the impact of incorporating cultural specificity improves the effectiveness. This program utilizes non-medically trained personnel as coaches and is relatively inexpensive, with potential for great cost savings in prevention of cardiovascular disease.
The prevalence of obesity increased in the United States between 1976-1980 and 1988-1994 and again between 1988-1994 and 1999-2000.
To examine trends in obesity from 1999 through 2008 and the current prevalence of obesity and overweight for 2007-2008.
Analysis of height and weight measurements from 5555 adult men and women aged 20 years or older obtained in 2007-2008 as part of the National Health and Nutrition Examination Survey (NHANES), a nationally representative sample of the US population. Data from the NHANES obtained in 2007-2008 were compared with results obtained from 1999 through 2006.
Estimates of the prevalence of overweight and obesity in adults. Overweight was defined as a body mass index (BMI) of 25.0 to 29.9. Obesity was defined as a BMI of 30.0 or higher.
In 2007-2008, the age-adjusted prevalence of obesity was 33.8% (95% confidence interval [CI], 31.6%-36.0%) overall, 32.2% (95% CI, 29.5%-35.0%) among men, and 35.5% (95% CI, 33.2%-37.7%) among women. The corresponding prevalence estimates for overweight and obesity combined (BMI > or = 25) were 68.0% (95% CI, 66.3%-69.8%), 72.3% (95% CI, 70.4%-74.1%), and 64.1% (95% CI, 61.3%-66.9%). Obesity prevalence varied by age group and by racial and ethnic group for both men and women. Over the 10-year period, obesity showed no significant trend among women (adjusted odds ratio [AOR] for 2007-2008 vs 1999-2000, 1.12 [95% CI, 0.89-1.32]). For men, there was a significant linear trend (AOR for 2007-2008 vs 1999-2000, 1.32 [95% CI, 1.12-1.58]); however, the 3 most recent data points did not differ significantly from each other.
In 2007-2008, the prevalence of obesity was 32.2% among adult men and 35.5% among adult women. The increases in the prevalence of obesity previously observed do not appear to be continuing at the same rate over the past 10 years, particularly for women and possibly for men.
Overweight and obesity are increasing dramatically in the United States and most likely contribute substantially to the burden of chronic health conditions.
To describe the relationship between weight status and prevalence of health conditions by severity of overweight and obesity in the US population.
Nationally representative cross-sectional survey using data from the Third National Health and Nutrition Examination Survey (NHANES III), which was conducted in 2 phases from 1988 to 1994.
A total of 16884 adults, 25 years and older, classified as overweight and obese (body mass index [BMI] > or =25 kg/m2) based on National Institutes of Health recommended guidelines.
Prevalence of type 2 diabetes mellitus, gallbladder disease, coronary heart disease, high blood cholesterol level, high blood pressure, or osteoarthritis.
Sixty-three percent of men and 55% of women had a body mass index of 25 kg/m2 or greater. A graded increase in the prevalence ratio (PR) was observed with increasing severity of overweight and obesity for all of the health outcomes except for coronary heart disease in men and high blood cholesterol level in both men and women. With normal-weight individuals as the reference, for individuals with BMIs of at least 40 kg/m2 and who were younger than 55 years, PRs were highest for type 2 diabetes for men (PR, 18.1; 95% confidence interval [CI], 6.7-46.8) and women (PR, 12.9; 95% CI, 5.7-28.1) and gallbladder disease for men (PR, 21.1; 95% CI, 4.1-84.2) and women (PR, 5.2; 95% CI, 2.9-8.9). Prevalence ratios generally were greater in younger than in older adults. The prevalence of having 2 or more health conditions increased with weight status category across all racial and ethnic subgroups.
Based on these results, more than half of all US adults are considered overweight or obese. The prevalence of obesity-related comorbidities emphasizes the need for concerted efforts to prevent and treat obesity rather than just its associated comorbidities.
The compliance score in randomized trials is a measure of the effect of randomization on treatment received. It is in principle a group-level pretreatment variable and so can be used where individual-level measures of treatment received can produce misleading inferences. The interpretation of models with the compliance score as a regressor of interest depends on the link function. Using the identity link can lead to valid inference about the effects of treatment received even in the presence of nonrandom noncompliance; such inference is more problematic for nonlinear links. We illustrate these points with data from two randomized trials.
Recent advances in statistical software have led to the rapid diffusion of new methods for modelling longitudinal data. Multilevel (also known as hierarchical or random effects) models for binary outcomes have generally been based on a logistic-normal specification, by analogy with earlier work for normally distributed data. The appropriate application and interpretation of these models remains somewhat unclear, especially when compared with the computationally more straightforward semiparametric or 'marginal' modelling (GEE) approaches. In this paper we pose two interrelated questions. First, what limits should be placed on the interpretation of the coefficients and inferences derived from random-effect models involving binary outcomes? Second, what diagnostic checks are appropriate for evaluating whether such random-effect models provide adequate fits to the data? We address these questions by means of an extended case study using data on adolescent smoking from a large cohort study. Bayesian estimation methods are used to fit a discrete-mixture alternative to the standard logistic-normal model, and posterior predictive checking is used to assess model fit. Surprising parallels in the parameter estimates from the logistic-normal and mixture models are described and used to question the interpretability of the so-called 'subject-specific' regression coefficients from the standard multilevel approach. Posterior predictive checks suggest a serious lack of fit of both multilevel models. The results do not provide final answers to the two questions posed, but we expect that lessons learned from the case study will provide general guidance for further investigation of these important issues.
To assess, in a 1-year randomized controlled trial, the efficacy of eDiets.com (a commercial Internet weight loss program) in improving weight, cardiovascular health, and quality of life.
Participants were 47 women with a mean age of 43.7 +/- 10.2 (SD) years and a mean BMI of 33.5 +/- 3.1 kg/m2. They were randomly assigned to either: 1) eDiets.com, a commercial Internet-based program available to the public; or 2) a weight loss manual (i.e., LEARN Program for Weight Control 2000). At baseline, participants in both groups met briefly with a psychologist who instructed them to follow the components of their program as closely as possible. Additional brief visits were provided at weeks 8, 16, 26, and 52 to review their progress. Change in weight was the main outcome measure.
At week 16, participants in eDiets.com lost 0.9 +/- 3.2% of initial weight compared with 3.6 +/- 4.0% for women assigned to the weight loss manual. At week 52, losses increased to 1.1 +/- 4.0% and 4.0 +/- 5.1%, respectively. Results of a last-observation-carried-forward analysis found that women in the manual group lost significantly (p < 0.05) more weight (at both times) than those treated by eDiets.com. (Results, however, of baseline-carried-forward and completers analyses did not reach statistical significance.) There were no significant differences between groups in changes in cardiovascular risk factors or quality of life.
This study provides consumers with important information about the probable benefits they can expect from participating in a popular Internet-based weight loss program.
We evaluated lifestyle interventions for diabetic persons who live in rural communities.
We conducted a 12-month randomized clinical trial (n = 152) of "intensive-lifestyle" (modeled after the NIH Diabetes Prevention Program) and "reimbursable-lifestyle" (intensive-lifestyle intervention delivered in the time allotted for Medicare reimbursement for diabetes education related to nutrition and physical activity) interventions with usual care as a control.
Modest weight loss occurred by 6 months among intensive-lifestyle participants and was greater than the weight loss among usual-care participants (2.6 kg vs 0.4 kg, P<.01). At 12 months, a greater proportion of intensive-lifestyle participants had lost 2 kg or more than usual-care participants (49% vs 25%, P<.05). No differences in weight change were observed between reimbursable-lifestyle and usual-care participants. Glycated hemoglobin was reduced among all groups (P<.05) but was not different between groups.
Improvement in both weight and glycemia was attainable by lifestyle interventions designed for persons who had type 2 diabetes and lived in rural communities.
Effective clinical weight management approaches are needed to reach African-Americans.
African-Americans recruited through outpatient practices for a culturally-adapted Healthy Eating and Lifestyle Program were offered 10 weekly weight loss classes (Phase 1) with the option of continuing for another 8-18 months (Phase 2) in a randomized comparison of further group counseling or staff-facilitated self-help vs. follow-up clinic visits only.
Of 237 enrollees (91% women; mean age 43.5 years; mean body mass index 38.0 kg/m(2)), 70 [corrected] attended no classes or only the first Phase 1 class, 134 provided Phase 1 follow-up data, 128 were randomized in Phase 2, and 87 provided final follow-up data ("completers"). Mean weight changes for completers were: -1.5 (P < 0.001), +0.3 (P = 0.47), and -1.2 (P = 0.04) kg, respectively, for Phase 1, Phase 2, and overall (baseline to final visit; average 18 months total duration), with no Phase 2 treatment effect (P = 0.55). Final study weight was > or =5% below baseline for 25% of completers and was strongly predicted by Phase 1 weight loss.
Weight loss achieved in Phase 1 was maintained even with relatively minimal follow-up contact. Increasing the percent who achieve clinically significant weight loss initially would improve long-term results.
We examined associations between neighborhood demographic characteristics and the availability of commercial physical activity-related outlets by zip code across the United States.
Multivariate analyses were conducted to assess the availability of 4 types of outlets: (1) physical fitness facilities, (2) membership sports and recreation clubs, (3) dance facilities, and (4) public golf courses. Commercial outlet data were linked by zip code to US Census Bureau population and socioeconomic data.
Results showed that commercial physical activity-related facilities were less likely to be present in lower-income neighborhoods and in neighborhoods with higher proportions of African American residents, residents with His-panic ethnicity, and residents of other racial minority backgrounds. In addition, these neighborhoods had fewer such facilities available.
Lack of availability of facilities that enable and promote physical activity may, in part, underpin the lower levels of activity observed among populations of low socioeconomic status and minority backgrounds.
To determine whether a tailored weight management program, addressing the needs of obese, low-income African-American women, would produce greater weight loss than standard medical care.
A randomized, controlled trial was conducted between 1999 and 2003 with 144 overweight or obese women (predominantly African-American) enrolled at two primary care clinics. Four physicians at each clinic were randomly assigned to provide either tailored weight management interventions or standard care. The tailored condition consisted of six monthly outpatient visits lasting approximately 15 minutes each, which included personalized materials and messages. The main outcome was body weight change.
The intervention group lost more weight than the standard care group (p = 0.03). The tailored group lost a mean (standard deviation) of 2.0 (3.2) kg by Month 6. The standard care group gained 0.2 (2.9) kg. More participants in the tailored group lost weight (79% vs. 47%; p = 0.04).
Obese, low-income, African-American women provided with 90 minutes of physician-delivered, tailored weight management instruction over 6 months achieved greater weight loss than those receiving standard medical care. The primary care physician can be effective in delivering weight loss interventions, and the primary care clinic may be a useful setting to implement weight management interventions.
Long-term shifts in specialty choice and health workforce policy have raised concern about the future of primary care in the United States. The objective of this study was to examine current use of primary and specialty care across the US population for policy-relevant subgroups, such as disadvantaged populations and persons with chronic illness.
Data from the Medical Expenditure Panel Survey from 2004 were analyzed using a probability sample patients or other participants from the noninstitutionalized US population in 2004 (N = 34,403). The main and secondary outcome measures were the estimates of the proportion of Americans who accessed different types of primary care and specialty physicians and midlevel practitioners, as well as the fraction of ambulatory visits accounted for by the different clinician types. Data were disaggregated by income, health insurance status, race/ethnicity, rural or urban residence, and presence of 5 common chronic diseases.
Family physicians were the most common clinician type accessed by adults, seniors, and reproductive-age women, and they were second to pediatricians for children. Disadvantaged adults with 3 markers of disadvantage (poverty, disadvantaged minority, uninsured) received 45.6% (95% CI, 40.4%-50.7%) of their ambulatory visits from family physicians vs 30.5% (95% CI, 30.0%-32.1%) for adults with no markers. For children with 3 vs 0 markers of disadvantage, the proportion of visits from family physicians roughly doubled from 16.5% (95% CI, 14.4%-18.6%) to 30.1% (95% CI, 18.8%-41.2%). Family physicians constitute the only clinician group that does not show income disparities in access. Multivariate analyses show that patterns of access to family physicians and nurse-practitioners are more equitable than for other clinician types.
Primary care clinicians, especially family physicians, deliver a disproportionate share of ambulatory care to disadvantaged populations. A diminished primary care workforce will leave considerable gaps in US health care equity. Health care workforce policy should reflect this important population-level function of primary care.
Risk of first heart attack was found to be related inversely to energy expenditure reported by 16,936 Harvard male alumni, aged 35–74 years, of whom 572 experienced heart attacks in 117,680 person-years of followup. Stairs climbed, blocks walked, strenuous sports played, and a composite physical activity index all opposed risk. Men with index below 2000 kilocalories per week were at 64% higher risk than classmates with higher Index. Adult exercise was independent other influences on heart attack risk, and peak exertion as strenuous sports play enhanced the effect of total energy expenditure. Notably, alumni physical activity supplanted student athleticisn; assessed in college 16–50 years earlier. If it is postulated that varsity athlete status implies selective cardiovascular fitness, such selection alone is insufficient to explain lower heart attack risk in later adult years. Ex-varsity athletes retained lower risk only if they maintained high physical activity Index as alumni.
This statement summarizes the U.S. Preventive Services Task Force (USPSTF) recommendations on screening for obesity in adults based on the USPSTF's examination of evidence specific to obesity and overweight in adults and updates the 1996 recommendations on this topic. The complete USPSTF recommendation and rationale statement on this topic, which includes a brief review of the supporting evidence, is available through the USPSTF Web site (www.preventiveservices.gov), the National Guideline Clearinghouse (www.guideline.gov), and in print through the Agency for Healthcare Research and Quality Publications Clearinghouse (telephone, 800-358-9295; e-mail, ahrqpubs@ahrq.gov). The complete information on which this statement is based, including evidence tables and references, is available in the accompanying article in this issue and in the summary of the evidence and systematic evidence review on the Web sites already mentioned. The summary of the evidence is also available in print through the Agency for Healthcare Research and Quality Publications Clearinghouse.
Background: Obesity poses a considerable and growing health burden. This review examines evidence for screening and treating obesity in adults. Data Sources: MEDLINE and Cochrane Library (January 1994 through February 2003). Study Selection: Systematic reviews; randomized, controlled trials; and observational studies of obesity's health outcomes or efficacy of obesity treatment. Data Extraction: Two reviewers independently abstracted data on study design, sample, sample size, treatment, outcomes, and quality. Data Synthesis: No trials evaluated mass screening for obesity, so the authors evaluated indirect evidence for efficacy. Pharmacotherapy or counseling interventions produced modest (generally 3 to 5 kg) weight loss over at least 6 or 12 months, respectively. Counseling was most effective when intensive and combined with behavioral therapy. Maintenance strategies helped retain weight loss. Selected surgical patients lost substantial weight (10 to 159 kg over 1 to 5 years). Weight reduction improved blood pressure, lipid levels, and glucose metabolism and decreased diabetes incidence. The internal validity of the treatment trials was fair to good, and external validity was limited by the minimal ethnic or gender diversity of volunteer participants. No data evaluated counseling harms. Primary adverse drug effects included hypertension with sibutramine (mean increase, 0 mm Hg to 3.5 mm Hg) and gastrointestinal distress with orlistat (1% to 37% of patients). Fewer than 1% (pooled samples) of surgical patients died; up to 25% needed surgery again over 5 years. Conclusions: Counseling and pharmacotherapy can promote modest sustained weight loss, improving clinical outcomes. Pharmacotherapy appears safe in the short term; long-term safety has not been as strongly established. In selected patients, surgery promotes large amounts of weight loss with rare but sometimes severe complications.
About 97 million adults in the United States are overweight or obese. Obesity and overweight substantially increase the risk of morbidity from hypertension; dyslipidemia; type 2 diabetes; coronary heart disease; stroke; gallbladder disease; osteoarthritis; sleep apnea and respiratory problems; and endometrial, breast, prostate, and colon cancers. Higher body weights are also associated with increases in all-cause mortality. The aim of this guideline is to provide useful advice on how to achieve weight reduction and maintenance of a lower body weight. It is also important to note that prevention of further weight gain can be a goal for some patients. Obesity is a chronic disease, and both the patient and the practitioner need to understand that successful treatment requires a life-long effort. Assessment of Weight and Body Fat Two measures important for assessing overweight and total body fat content are; determining body mass index (BMI) and measuring waist circumference. 1. Body Mass Index: The BMI, which describes relative weight for height, is significantly correlated with total body fat content. The BMI should be used to assess overweight and obesity and to monitor changes in body weight. Measurements of body weight alone can be used to determine efficacy of weight loss therapy. BMI is calculated as weight (kg)/height squared (m 2). To estimate BMI using pounds and inches, use: [weight (pounds)/height (inches) 2 ] x 703. Weight classifications by BMI, selected for use in this report, are shown in the table below. • Pregnant women who, on the basis of their pre-pregnant weight, would be classified as obese may encounter certain obstetrical risks. However, the inappropriateness of weight reduction during pregnancy is well recognized (Thomas, 1995). Hence, this guideline specifically excludes pregnant women. Source (adapted from): Preventing and Managing the Global Epidemic of Obesity. Report of the World Health Organization Consultation of Obesity. WHO, Geneva, June 1997.
This paper provides an overview of intent-to-treat analysis versus as-treated analysis. The first step in evaluating a therapy must be an unbiased intent-to-treat analysis. This is the only sure way to protect against potential bias. As-treated analyses, however, can be used in some situations, and methodology to provide objective secondary analyses should be pursued. A two-arm clinical trial of an active treatment versus placebo control will be used to illustrate the two procedures.
Most primary care providers (PCPs), constrained by time and resources, cannot provide intensive behavioral counseling for obesity. This study evaluated the effect of using medical assistants (MAs) as weight loss counselors. The study was a randomized controlled trial conducted in two primary care offices at an academic medical center. Patients (n = 50) had a BMI of 27-50 kg/m(2) and no contraindications to weight loss. They were randomized to quarterly PCP visits and weight loss materials (Control group) or to the same approach combined with eight visits with a MA over 6 months (Brief Counseling). Outcomes included change in weight and cardiovascular risk factors (glucose, lipids, blood pressure, and waist circumference). Patients in the Brief Counseling and Control groups lost 4.4 +/- 0.6 kg (5.1 +/- 0.7% of initial weight) and 0.9 +/- 0.6 kg (1.0 +/- 0.7%), respectively, at month 6 (P < 0.001). There were no significant differences between groups for changes in cardiovascular risk factors. Brief Counseling patients regained weight between month 6 and month 12, when MA visits were discontinued. Attrition was 10% after 6 months and 6% after 12 months. Brief Counseling by MAs induced significant weight loss during 6 months. Office-based obesity treatment should be tested in larger trials and should include weight loss maintenance counseling.
This review examines the results of randomized controlled trials in which behavioral weight loss interventions, used alone or with pharmacotherapy, were provided in primary care settings.
Literature search of MEDLINE, PubMed, Cochrane Systematic Reviews, CINAHL, and EMBASE (1950-present). Inclusion criteria for studies were: (1) randomized trial, (2) obesity intervention in US adults, and (3) conducted in primary care or explicitly intended to model a primary care setting.
Both authors reviewed each study to extract treatment modality, provider, setting, weight change, and attrition. The CONSORT criteria were used to assess study quality. Due to the small number and heterogeneity of studies, results were summarized but not pooled quantitatively.
Ten trials met the inclusion criteria. Studies were classified as: (1) PCP counseling alone, (2) PCP counseling + pharmacotherapy, and (3) "collaborative" obesity care (treatment delivered by a non-physician provider). Weight losses in the active treatment arms of these categories of studies ranged from 0.1 to 2.3 kg, 1.7 to 7.5 kg, and 0.4 to 7.7 kg, respectively. Most studies provided low- or moderate-intensity counseling, as defined by the US Preventive Services Task Force.
Current evidence does not support the use of low- to moderate-intensity physician counseling for obesity, by itself, to achieve clinically meaningful weight loss. PCP counseling plus pharmacotherapy, or intensive counseling (from a dietitian or nurse) plus meal replacements may help patients achieve this goal. Further research is needed on different models of managing obesity in primary care practice.
This report provides a further analysis of the first year weight losses in the Look AHEAD (Action for Health in Diabetes) study and identifies factors associated with success. Participants were a total of 5,145 men and women with type 2 diabetes who were recruited at 16 sites and randomly assigned to an intensive lifestyle intervention (ILI) or a control condition, Diabetes Support and Education (DSE). During year 1, participants in ILI received comprehensive diet and physical activity counseling in a total of 42 group and individual sessions, compared with three educational sessions for DSE participants. As reported previously, at the end of the year, ILI participants lost 8.6% of initial weight, compared to 0.7% for DSE (P < 0.001). Within the ILI group, all racial/ethnic groups achieved clinically significant weight losses (>5.5%), although there were significant differences among groups. For the year, ILI participants attended an average of 35.4 treatment sessions and reported exercising a mean of 136.6 min/week and consuming a total of 360.9 meal replacement products. Greater self-reported physical activity was the strongest correlate of weight loss, followed by treatment attendance and consumption of meal replacements. The use of orlistat, during the second half of the year, increased weight loss only marginally in those ILI participants who had lost <5% of initial weight during the first 6 months and chose to take the medication thereafter as a toolbox option. The lifestyle intervention was clinically effective in all subsets of an ethnically and demographically diverse population.
This report describes ambulatory care visits made to physician offices in the United States. Statistics are presented on selected characteristics of the physician's practice, the patient, and the visit.
The data presented in this report were collected in the 2006 National Ambulatory Medical Care Survey (NAMCS), a national probability sample survey of visits to nonfederal office-based physicians in the United States. Sample data are weighted to produce annual national estimates of physician visits.
During 2006, an estimated 902 million visits were made to physician offices in the United States, an overall rate of 306.6 visits per 100 persons. In over one-quarter of office visits, electronic medical records were utilized by physicians, while at 85.5 percent of visits, claims were submitted electronically. Since 1996, the percentage of visits by adults 18 years and over with chronic diabetes increased 40%, and during the same time period, visits increased for chronic hypertension (28%), and depression (27%). Among visits by females, a Pap test was ordered or provided more frequently than a human papilloma virus DNA test (5.6 versus 0.6 percent). Private insurance visits were more likely to include liquid-based Pap tests (6.3 percent) compared with visits using conventional or unspecified tests (3.7 percent), whereas visits utilizing Medicaid and other sources of payment were equally likely to provide conventional or unspecified, and liquid-based Pap tests. Medication therapy was reported at 636.7 million office visits, accounting for 70.6 percent of all office visits. In 2006, there were about 1.9 billion drugs mentioned, resulting in an overall 210.3 drug mentions per 100 visits. Visits to primary care physicians at community health centers were more likely to document health education compared with office-based practices, whereas diagnostic or screening services, drug mentions, and any nonmedication treatment occurred at approximately the same proportion of visits for primary care providers in both type of settings.
This report presents statistics on ambulatory care visits to physician offices, hospital outpatient departments (OPDs), and hospital emergency departments (EDs) in the United States in 2006. Ambulatory medical care utilization is described in terms of patient, practice, facility, and visit characteristics.
Data from the 2006 National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) were combined to produce annual estimates of ambulatory medical care utilization.
Patients in the United States made an estimated 1.1 billion visits to physician offices and hospital OPDs and EDs, a rate of 381.9 visits per 100 persons annually. The overall visit rate was not significantly different for white and black persons. However, black persons had higher visit rates than white persons to hospital OPDs and EDs and lower visit rates to office-based surgical and medical specialists. Visit distribution by ambulatory care setting differed by poverty level in the patient's ZIP Code of residence, with higher proportions of visits to hospital OPDs and EDs as poverty levels increased. Between 1996 and 2006, visit rates to medical specialty offices climbed overall by 29 percent, with a significant increase noted for white patients but not black patients. The rate of OPD visits jumped from 25.4 visits per 100 persons in 1996 to 34.7 in 2006, whereas ED visits during the same period increased from 34.1 to 40.5 per 100 persons. About 18.3 percent of all ambulatory care visits in 2006 were for nonillness or noninjury conditions, such as routine checkups and pregnancy exams. Seven in ten ambulatory care visits had at least one medication provided, prescribed, or continued in 2006, for a total of 2.6 billion drugs overall. Analgesics were the most common therapeutic category, accounting for 13.6 drugs per 100 drugs prescribed, and they were most often utilized at primary care and ED visits. The percentage of visits at which medication was prescribed increased significantly in most settings between 1996 and 2006.
Although the primary care setting offers an innovative option for weight loss interventions, there is minimal research examining this type of intervention with low-income minority women. Further, there is a lack of research on the long-term effects of these programs. The purpose of this investigation was to examine the weight loss maintenance of low-income African-American women participating in a primary care weight management intervention. A randomized controlled trial was conducted with overweight and obese women (N = 144) enrolled at two primary care clinics. Women received a 6-month tailored weight loss intervention delivered by their primary care physician and completed follow-up assessments 9, 12, and 18 months following randomization. The weight loss maintenance of the tailored intervention was compared to a standard care comparison group. The weight loss of intervention participants (-1.52 +/- 3.72 kg) was significantly greater than that of standard care participants (0.61 +/- 3.37 kg) at month 9 (P = 0.01). However, there was no difference between the groups at the 12-month or 18-month follow-ups. Participants receiving a tailored weight loss intervention from their physician were able to maintain their modest weight loss up to 3-6 months following treatment. Women demonstrated weight regain at the 18-month follow-up assessment, suggesting that more intensive follow-up in the primary care setting may be needed to obtain successful long-term weight loss maintenance.
Risk of first heart attack was found to be related inversely to energy expenditure reported by 16,936 Harvard male alumni, aged 35-74 years, of whom 572 experienced heart attacks in 117,680 person-years of followup. Stairs climbed, blocks walked, strenuous sports played, and a composite physical activity index all opposed risk. Men with index below 2000 kilocalories per week were at 64% higher risk than classmates with higher index. Adult exercise was independent of other influences on heart attack risk, and peak exertion as strenuous sports play enhanced the effect of total energy expenditure. Notably, alumni physical activity supplanted student athleticism assessed in college 16-50 years earlier. If it is postulated that varsity athlete status implies selective cardiovascular fitness, such selection alone is insufficient to explain lower heart attack risk in later adult years. Ex-varsity athletes retained lower risk only if they maintained a high physical activity index as alumni.
Studies designed to examine effects of weight reduction by dieting on total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), high-density-lipoprotein cholesterol (HDL-C), very-low-density-lipoprotein cholesterol (VLDL-C), and triglycerides (TGs) have reported inconsistent results. The purpose of this study was to quantify effects of weight loss by dieting on lipids and lipoproteins through the review method of meta-analysis. Results from the 70 studies analyzed indicated that weight reduction was associated with significant decreases (P less than or equal to 0.001) and correlations (P less than or equal to 0.05) for TC (r = 0.32), LDL-C (r = 0.29), VLDL-C (r = 0.38), and TG (r = 0.32). For every kilogram decrease in body weight, a 0.009-mmol/L increase (P less than or equal to 0.01) in HDL-C occurred for subjects at a stabilized, reduced weight and a 0.007-mmol/L decrease (P less than or equal to 0.05) for subjects actively losing weight. Our results indicate that weight reduction through dieting can be a viable approach to help normalize plasma lipids and lipoproteins in overweight individuals.
To determine the effect of moderate dietary sodium restriction on the hypertension of non-insulin-dependent (type II) diabetes.
Randomised parallel controlled study of moderate sodium restriction for three months compared with usual diabetic diet, followed by randomised double blind crossover trial of sustained release preparation of sodium for one month versus placebo for one month in patients continuing with sodium restriction.
Patients attending diabetic outpatient clinic of city hospital.
Thirty four patients with established type II diabetes complicated by mild hypertension (systolic blood pressure greater than 160 mm Hg or diastolic pressure greater than 95 mm Hg on three consecutive occasions). Patients already taking antihypertensive agents (but not diuretics) not barred from study provided that criteria for mild hypertension still met. Conditions precluding patients from study were diabetic or hypertensive nephropathy, cardiac failure, and pregnancy.
After run in phase with recordings at seven weeks, three weeks, and time zero patients were allocated at random to receive moderate dietary sodium restriction for three months (n = 17) or to continue with usual diabetic diet. Subsequently nine patients in sodium restriction group continued with regimen for a further two months, during which they completed a randomised double blind crossover trial of sustained release preparation of sodium (Slow Sodium 80 mmol daily) for one month versus matching placebo for one month.
Reduction in blood pressure in type II diabetics with mild hypertension.
Supine and erect blood pressure, body weight, and 24 hour urinary sodium and potassium excretion measured monthly during parallel group and double blind crossover studies. After parallel group study sodium restriction group showed significant reduction in systolic blood pressure (supine 19.2 mm Hg, erect 21.4 mm Hg; p less than 0.001) and mean daily urinary sodium excretion (mean reduction 60 mmol/24 h). There were no appreciable changes in weight, diabetic control, or diastolic pressure. No significant changes occurred in controls. In double blind crossover study mean supine systolic blood pressure rose significantly (p less than 0.005) during sodium supplementation (to 171 mm Hg) compared with value after three months of sodium restriction alone (159.9 mm Hg) and after one month of placebo (161.8 mm Hg).
Moderate dietary restriction of sodium has a definite hypotensive effect, which may be useful in mild hypertension of type II diabetes.
The purpose of this study was to develop measures of perceived social support specific to health-related eating and exercise behaviors. In Study I, specific supportive and nonsupportive behaviors were identified through interviews with 40 individuals making health-behavior changes. In Study II, items derived from the interviews were administered to 171 subjects. Support from family and friends was assessed separately for both diet and exercise habits. Meaningful factors were identified for each of the four scales, and some factors were similar for family and friend scales. Both test-retest and internal consistency reliabilities were acceptable, and six factors can be used as subscales. Social support scales were correlated with respective self-reported dietary and exercise habits, providing evidence of concurrent criterion-related validity. A measure of general social support was not related to the specific social support scales or to reported health habits. These scales are among the first measures of social support behaviors specific to dietary- and exercise-habit change.
This paper presents evidence from three samples, two of college students and one of participants in a community smoking-cessation program, for the reliability and validity of a 14-item instrument, the Perceived Stress Scale (PSS), designed to measure the degree to which situations in one's life are appraised as stressful. The PSS showed adequate reliability and, as predicted, was correlated with life-event scores, depressive and physical symptomatology, utilization of health services, social anxiety, and smoking-reduction maintenance. In all comparisons, the PSS was a better predictor of the outcome in question than were life-event scores. When compared to a depressive symptomatology scale, the PSS was found to measure a different and independently predictive construct. Additional data indicate adequate reliability and validity of a four-item version of the PSS for telephone interviews. The PSS is suggested for examining the role of nonspecific appraised stress in the etiology of disease and behavioral disorders and as an outcome measure of experienced levels of stress.
Type 2 diabetes affects approximately 8 percent of adults in the United States. Some risk factors--elevated plasma glucose concentrations in the fasting state and after an oral glucose load, overweight, and a sedentary lifestyle--are potentially reversible. We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes.
We randomly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo, metformin (850 mg twice daily), or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week. The mean age of the participants was 51 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 34.0; 68 percent were women, and 45 percent were members of minority groups.
The average follow-up was 2.8 years. The incidence of diabetes was 11.0, 7.8, and 4.8 cases per 100 person-years in the placebo, metformin, and lifestyle groups, respectively. The lifestyle intervention reduced the incidence by 58 percent (95 percent confidence interval, 48 to 66 percent) and metformin by 31 percent (95 percent confidence interval, 17 to 43 percent), as compared with placebo; the lifestyle intervention was significantly more effective than metformin. To prevent one case of diabetes during a period of three years, 6.9 persons would have to participate in the lifestyle-intervention program, and 13.9 would have to receive metformin.
Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk. The lifestyle intervention was more effective than metformin.
This report describes ambulatory care visits made to physician offices within the United States. Statistics are presented on selected characteristics of the physician's practice, the patient, and the visit. Highlights of trends in physician office visit utilization from 1997 through 2000 are also presented.
The data presented in this report were collected from the 2000 National Ambulatory Medical Care Survey (NAMCS). NAMCS is part of the ambulatory care component of the National Health Care Survey that measures health care utilization across various types of providers. NAMCS is a national probability sample survey of visits to office-based physicians in the United States. Sample data are weighted to produce annual national estimates. Trends are based on NAMCS data from 1997 through 2000.
During 2000, an estimated 823.5 million visits were made to physician offices in the United States, an overall rate of 300.4 visits per 100 persons. Approximately half of the visits were made to the patient's primary care physician. The proportion of office visits where a physician or physician group was the owner of the practice has steadily increased since 1997 (74.3 percent in 1997 versus 88.1 percent in 2000). Of all visits made to these offices in 2000, approximately 57 percent listed private insurance as the primary expected source of payment, and 29 percent were made by patients belonging to a health maintenance organization. There were an estimated 89.9 million injury-related visits during 2000, or 32.8 visits per 100 persons. Blood pressure check was the leading diagnostic screening test (45.3 percent) and males were more likely than females to have no diagnostic or screening services mentioned. The proportion of visits with at least one prescription for cardiovascular-renal drugs, hormones, or metabolic/nutrient drugs has increased since 1997.
Analyses of longitudinal quality of life (QOL) for patients with advanced stage disease are frequently plagued by problems of non-random drop-out attributable to deteriorating health and/or death. As an example, Moinpour et al. cite specific challenges which limited their report and assessment of QOL for patients treated for advanced stage colorectal cancer in a clinical trial of several chemotherapeutic regimes performed by the Southwest Oncology Group. A particular source of confusion that arises in studies of advanced stage disease is whether or not to differentiate loss of follow-up due to death from drop-out where the patient is still alive but has dropped from the study. In this paper we examine exploratory data techniques for longitudinal QOL data with non-random missingness due to drop-out and censorship by death. We propose a pattern mixture model for longitudinal QOL, time of drop-out and survival, which allows for straightforward implementation of sensitivity analyses and explicit comparisons to the raw data. Our method is illustrated in the context of analysing the data and addressing the challenges posed by Moinpour et al.
T his article provides an overview of our current understanding of the epidemiology of obesity, the metabolic syndrome, and hypertension among racial/ethnic groups. Three presentations made at the conference by the present writing group are summarized and updated with other information on ethnic groups, and recommendations developed by the writing group for programs, public policy, and research are put forward.
Clinical trials in psychiatry frequently fail to maximize clinical utility for practicing clinicians, or, stated differently, available evidence is not perceived by clinicians (and other decision makers) as sufficiently relevant to clinical practice, thereby diluting its impact. To attain maximum clinical relevance and acceptability, researchers must conduct clinical trials designed to meet the needs of clinicians and others who are making decisions about patients' care. The authors present the case for psychiatry's adoption of the practical clinical trials model, which is widely used in research in other areas of medicine.
The authors outline the characteristics and scope of practical clinical trials, give examples of practical clinical trials, and discuss the challenges of using the practical clinical trials model in psychiatry, including issues of funding.
Practical clinical trials, which are intended to provide generalizable answers to important clinical questions without bias, are characterized by eight key features: a straightforward clinically relevant question, a representative sample of patients and practice settings, sufficient power to identify modest clinically relevant effects, randomization to protect against bias, clinical uncertainty regarding the outcome of treatment at the patient level, assessment and treatment protocols that enact best clinical practices, simple and clinically relevant outcomes, and limited subject and investigator burden.
To implement the practical clinical trials model in psychiatry will require stable funding for network construction and maintenance plus methodological innovation in governance and trial selection, assessment, treatment, data management, site management, and data analytic procedures.
This study provides a multivariate analysis of the availability of food store outlets in the US and associations with neighborhood characteristics on race, ethnicity and socioeconomic status (SES).
Commercial food store outlet data are linked across 28,050 zip codes to Census 2000 data. Multivariate regression analyses are used to examine associations between the availability of chain supermarkets, non-chain supermarkets, grocery stores and convenience stores and neighborhood characteristics on race, ethnicity and SES including additional controls for population size, urbanization and region.
Low-income neighborhoods have fewer chain supermarkets with only 75% (p<0.01) of that available in middle-income neighborhoods. Even after controlling for income and other covariates, the availability of chain supermarkets in African American neighborhoods is only 52% (p<0.01) of that in White neighborhoods with even less relative availability in urban areas. Hispanic neighborhoods have only 32% (p<0.01) as many chain supermarkets compared to non-Hispanic neighborhoods. Non-chain supermarkets and grocery stores are more prevalent in low-income and minority neighborhoods.
The study results highlight the importance of various potential public policy measures for improving access to supermarkets that may serve to reduce systematic local area barriers that are shown to exist by race, ethnicity and income.
Recent work demonstrates the benefits of weight loss from intensive lifestyle modification. One barrier to counseling may be lack of reimbursement. We sought to quantify the obesity coverage policies of insurers in Pennsylvania. A three-page questionnaire was sent to eligible Pennsylvania health plans. Respondents included company medical directors and administrators from other departments, including public relations, provider relations, disease management, and utilization review. The questionnaire inquired about major treatment modalities for obesity, including details of coverage. Sixteen of 19 eligible plans (84%) responded. All plans provided some coverage for bariatric surgery. Nine out of 16 companies (56%) stated that they covered individual dietary counseling, but only five paid for intensive counseling. Less than 50% of plans reimbursed other forms of lifestyle modification or weight loss medication. Surgery was covered significantly more often than all other treatment modalities (P<0.02 for all comparisons). No differences in reimbursement were found by plan type or by number of enrollees. Insurance reimbursement for obesity in Pennsylvania does not consistently reflect recent evidence for the benefits of lifestyle modification. Given the increasing evidence for the clinical and cost-effectiveness of nonsurgical weight loss therapy, coverage policies may begin to change.
"Physicians-recruiting-physicians" is the preferred recruitment approach for practice-based research. However, yields are variable; and the approach can be costly and lead to biased, unrepresentative samples. We sought to explore the potential efficiency of alternative methods.
We conducted a retrospective analysis of the yield and cost of 10 recruitment strategies used to recruit primary care practices to a randomized trial to improve cardiovascular disease risk factor management. We measured response and recruitment yields and the resources used to estimate the value of each strategy. Providers at recruited practices were surveyed about motivation for participation.
Response to 6 opt-in marketing strategies was 0.40% (53/13290), ranging from 0% to 2.86% by strategy; 33.96% (18/53) of responders were recruited to the study. Of those recruited from opt-out strategies, 8.68% joined the study, ranging from 5.35% to 41.67% per strategy. A strategy that combined both opt-in and opt-out approaches resulted in a 51.14% (90/176) response and a 10.80% (19/90) recruitment rate. Cost of recruitment was $613 per recruited practice. Recruitment approaches based on in-person meetings (41.67%), previous relationships (33.33%), and borrowing an Area Health Education Center's established networks (10.80%), yielded the most recruited practices per effort and were most cost efficient. Individual providers who chose to participate were motivated by interest in improving their clinical practice (80.5%); contributing to CVD primary prevention (54.4%); and invigorating their practice with new ideas (42.1%).
This analysis provides suggestions for future recruitment efforts and research. Translational studies with limited funds could consider multi-modal recruitment approaches including in-person presentations to practice groups and exploitation of previous relationships, which require the providers to opt-out, and interactive opt-in approaches which rely on borrowed networks. These approaches can be supplemented with non-relationship-based opt-out strategies such as cold calls strategically targeted to underrepresented provider groups.
Change in dietary-fat behaviors was assessed in 95 African-American women in a culturally adapted weight-management program using the SisterTalk Food Habits Questionnaire. The hypothesis was that there would be no practical difference in ability to track dietary-fat behaviors related to weight change when using only 30 items from the SisterTalk Food Habits Questionnaire (about fat consumption frequency) compared to using all 91 items from the SisterTalk Food Habits Questionnaire (30 items plus additional details about behaviors). SisterTalk Food Habits Questionnaire responses use a scale of 1 to 4; higher numbers imply higher fat consumption. After an average of 18 months (n=49), a pre- to postintervention decrease in SisterTalk Food Habits Questionnaire score was observed using 91 items (-0.35) or 30 items (-0.28) (both P<0.001). Correlations between SisterTalk Food Habits Questionnaire change and change in body mass index were similar using 91 or 30 items (0.36 and 0.35, respectively, both P<0.05). Thirty questions measuring consumption frequency may provide adequate information about dietary-fat behavior changes associated with weight loss.
Our objective was to test the effect of physicians providing brief health lifestyle counseling to patients with type 2 diabetes mellitus during usual care visits.
We conducted a randomized controlled trial of a 12-month intervention at 2 large community health centers, enrolling 310 patients with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 25 or greater. In the intervention group, self-management goals for nutrition and physical activity were set using a tailored computer program. Goals were then reviewed at each clinic visit by physicians. The control group received only printed health education materials. The main outcome measures included change in physical activity and body weight.
In the intervention group, recommended levels of physical activity increased from 26% at baseline to 53% at 12 months (P< .001) compared with controls (30% to 37%; P= .27), and 32% of patients in the intervention group lost 6 or more pounds at 12 months compared with 18.9% of controls (odds ratio, 2.2; P= .006).
A brief intervention to increase the dialogue between patients and health care providers about behavioral goals can lead to increased physical activity and weight loss.
This editorial presents a perspective on the types of evidence most needed to advance behavioral medicine given the current status of the field.
The paper argues that the types of evidence most needed at present are evidence that is contextual, practical, and robust.
Each of the above issues is discussed with attention to characteristics of interventions; representativeness at the multiple levels of setting, clinical staff, and participants; and research design and measures. Arguments are made from philosophy of science, status of the literature, and future directions perspectives.
The current dominant paradigm of reductionistic studies focused predominantly on internal validity using highly homogenous patients and academic settings is not and will not produce the desired translation to real-world practice and policy. Instead, broader "practical" clinical and behavioral trials are needed that address the influence of the context in which programs are conducted, that include outcomes important to decision makers and communities, and that focus on moderating, mediating, and economic issues.
To create programs that will be disseminable, a greater focus is needed on external validity and transparency of reporting. We need to realize that the world is complex and embrace and study this complexity to produce further progress. Such an approach can produce evidence that is both rigorous and relevant.
To provide the specific weight loss outcomes for African-American, Hispanic, and white men and women in the lifestyle and metformin treatment arms of the Diabetes Prevention Program (DPP) by race-gender group to facilitate researchers translating similar interventions to minority populations, as well as provide realistic weight loss expectations for clinicians.
Secondary analyses of weight loss of 2,921 overweight participants (22% black; 17% Hispanic; 61% white; and 68% women) with impaired glucose tolerance randomized in the DPP to intensive lifestyle modification, metformin or placebo. Data over a 30-month period are examined for comparability across treatment arms by race and gender.
Within lifestyle treatment, all race-gender groups lost comparable amounts of weight with the exception of black women who exhibited significantly smaller weight losses (P < 0.01). For example, at 12 months, weight losses for white men (-8.4%), white women (-8.1%), Hispanic men (-7.8%), Hispanic women (-7.1%), and black men (-7.1%) were similar and significantly higher than black women (-4.5%). In contrast, within metformin treatment, all race-gender groups including black women lost similar amounts of weight. Race-gender specific mean weight loss data are provided by treatment arm for each follow-up period.
Diminished weight losses were apparent among black women in comparison with other race-gender groups in a lifestyle intervention but not metformin, underscoring the critical nature of examining sociocultural and environmental contributors to successful lifestyle intervention for black women.
To improve methods for long-term weight management, the Weight Loss Maintenance (WLM) trial, a four-center randomized trial, was conducted to compare alternative strategies for maintaining weight loss over a 30-month period. This paper describes methods and results for the initial 6-month weight-loss program (Phase I).
Eligible adults were aged > or =25, overweight or obese (BMI=25-45 kg/m2), and on medications for hypertension and/or dyslipidemia. Anthropomorphic, demographic, and psychosocial measures were collected at baseline and 6 months. Participants (n=1685) attended 20 weekly group sessions to encourage calorie restriction, moderate-intensity physical activity, and the DASH (dietary approaches to stop hypertension) dietary pattern. Weight-loss predictors with missing data were replaced by multiple imputation.
Participants were 44% African American and 67% women; 79% were obese (BMI> or =30), 87% were taking anti-hypertensive medications, and 38% were taking antidyslipidemia medications. Participants attended an average of 72% of 20 group sessions. They self-reported 117 minutes of moderate-intensity physical activity per week, kept 3.7 daily food records per week, and consumed 2.9 servings of fruits and vegetables per day. The Phase-I follow-up rate was 92%. Mean (SD) weight change was -5.8 kg (4.4), and 69% lost at least 4 kg. All race-gender subgroups lost substantial weight: African-American men (-5.4 kg +/- 7.7); African-American women (-4.1 kg +/- 2.9); non-African-American men (-8.5 kg +/- 12.9); and non-African-American women (-5.8 kg +/- 6.1). Behavioral measures (e.g., diet records and physical activity) accounted for most of the weight-loss variation, although the association between behavioral measures and weight loss differed by race and gender groups.
The WLM behavioral intervention successfully achieved clinically significant short-term weight loss in a diverse population of high-risk patients.
The Diabetes Prevention Program (DPP): description of lifestyle intervention
The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care.
2002; 25:2165–71. [PubMed: 12453955]
The development of scales to measure social support for diet and exercise behaviors
- Jf Sallis
- Rm Grossman
- Rb Pinski
- Tl Patterson
- Pr Nader
Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to
measure social support for diet and exercise behaviors. Prev Med. 1987; 16:825–36. [PubMed:
3432232]
Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report
Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in
Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998; 6(Suppl 2):51S–
209S. [PubMed: 9813653]