An RCT protocol of varying financial incentive amounts for smoking cessation among pregnant women

BMC Public Health (Impact Factor: 2.26). 11/2012; 12(1):1032. DOI: 10.1186/1471-2458-12-1032
Source: PubMed


Smoking during pregnancy is harmful to the unborn child. Few smoking cessation interventions have been successfully incorporated into standard antenatal care. The main aim of this study is to determine the feasibility of a personal financial incentive scheme for encouraging smoking cessation among pregnant women.
A pilot randomised control trial will be conducted to assess the feasibility and potential effectiveness of two varying financial incentives that increase incrementally in magnitude ($20 vs. $40AUD), compared to no incentive in reducing smoking in pregnant women attending an Australian public hospital antenatal clinic.
Ninety (90) pregnant women who self-report smoking in the last 7 days and whose smoking status is biochemically verified, will be block randomised into one of three groups: a. No incentive control group (n=30), b. $20 incremental incentive group (n=30), and c. $40 incremental incentive group (n=30). Smoking status will be assessed via a self-report computer based survey in nine study sessions with saliva cotinine analysis used as biochemical validation. Women in the two incentive groups will be eligible to receive a cash reward at each of eight measurement points during pregnancy if 7-day smoking cessation is achieved. Cash rewards will increase incrementally for each period of smoking abstinence.
Identifying strategies that are effective in reducing the number of women smoking during pregnancy and are easily adopted into standard antenatal practice is of utmost importance. A personal financial incentive scheme is a potential antenatal smoking cessation strategy that warrants further investigation.
Trial registration
Australian New Zealand Clinical Trials Registry (ANZCTR) number: ACTRN12612000399897

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    ABSTRACT: Tobacco smoking in pregnancy remains one of the few preventable factors associated with complications in pregnancy, stillbirth, low birthweight and preterm birth and has serious long-term implications for women and babies. Smoking in pregnancy is decreasing in high-income countries, but is strongly associated with poverty and increasing in low- to middle-income countries. To assess the effects of smoking cessation interventions during pregnancy on smoking behaviour and perinatal health outcomes. In this fifth update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2013), checked reference lists of retrieved studies and contacted trial authors to locate additional unpublished data. Randomised controlled trials, cluster-randomised trials, randomised cross-over trials, and quasi-randomised controlled trials (with allocation by maternal birth date or hospital record number) of psychosocial smoking cessation interventions during pregnancy. Two review authors independently assessed trials for inclusion and trial quality, and extracted data. Direct comparisons were conducted in RevMan, and subgroup analyses and sensitivity analysis were conducted in SPSS. Eighty-six trials were included in this updated review, with 77 trials (involving over 29,000 women) providing data on smoking abstinence in late pregnancy.In separate comparisons, counselling interventions demonstrated a significant effect compared with usual care (27 studies; average risk ratio (RR) 1.44, 95% confidence interval (CI) 1.19 to 1.75), and a borderline effect compared with less intensive interventions (16 studies; average RR 1.35, 95% CI 1.00 to 1.82). However, a significant effect was only seen in subsets where counselling was provided in conjunction with other strategies. It was unclear whether any type of counselling strategy is more effective than others (one study; RR 1.15, 95% CI 0.86 to 1.53). In studies comparing counselling and usual care (the largest comparison), it was unclear whether interventions prevented smoking relapse among women who had stopped smoking spontaneously in early pregnancy (eight studies; average RR 1.06, 95% CI 0.93 to 1.21). However, a clear effect was seen in smoking abstinence at zero to five months postpartum (10 studies; average RR 1.76, 95% CI 1.05 to 2.95), a borderline effect at six to 11 months (six studies; average RR 1.33, 95% CI 1.00 to 1.77), and a significant effect at 12 to 17 months (two studies, average RR 2.20, 95% CI 1.23 to 3.96), but not in the longer term. In other comparisons, the effect was not significantly different from the null effect for most secondary outcomes, but sample sizes were small.Incentive-based interventions had the largest effect size compared with a less intensive intervention (one study; RR 3.64, 95% CI 1.84 to 7.23) and an alternative intervention (one study; RR 4.05, 95% CI 1.48 to 11.11).Feedback interventions demonstrated a significant effect only when compared with usual care and provided in conjunction with other strategies, such as counselling (two studies; average RR 4.39, 95% CI 1.89 to 10.21), but the effect was unclear when compared with a less intensive intervention (two studies; average RR 1.19, 95% CI 0.45 to 3.12).The effect of health education was unclear when compared with usual care (three studies; average RR 1.51, 95% CI 0.64 to 3.59) or less intensive interventions (two studies; average RR 1.50, 95% CI 0.97 to 2.31).Social support interventions appeared effective when provided by peers (five studies; average RR 1.49, 95% CI 1.01 to 2.19), but the effect was unclear in a single trial of support provided by partners.The effects were mixed where the smoking interventions were provided as part of broader interventions to improve maternal health, rather than targeted smoking cessation interventions.Subgroup analyses on primary outcome for all studies showed the intensity of interventions and comparisons has increased over time, with higher intensity interventions more likely to have higher intensity comparisons. While there was no significant difference, trials where the comparison group received usual care had the largest pooled effect size (37 studies; average RR 1.34, 95% CI 1.25 to 1.44), with lower effect sizes when the comparison group received less intensive interventions (30 studies; average RR 1.20, 95% CI 1.08 to 1.31), or alternative interventions (two studies; average RR 1.26, 95% CI 0.98 to 1.53). More recent studies included in this update had a lower effect size (20 studies; average RR 1.26, 95% CI 1.00 to 1.59), I(2)= 3%, compared to those in the previous version of the review (50 studies; average RR 1.50, 95% CI 1.30 to 1.73). There were similar effect sizes in trials with biochemically validated smoking abstinence (49 studies; average RR 1.43, 95% CI 1.22 to 1.67) and those with self-reported abstinence (20 studies; average RR 1.48, 95% CI 1.17 to 1.87). There was no significant difference between trials implemented by researchers (efficacy studies), and those implemented by routine pregnancy staff (effectiveness studies), however the effect was unclear in three dissemination trials of counselling interventions where the focus on the intervention was at an organisational level (average RR 0.96, 95% CI 0.37 to 2.50). The pooled effects were similar in interventions provided for women with predominantly low socio-economic status (44 studies; average RR 1.41, 95% CI 1.19 to 1.66), compared to other women (26 studies; average RR 1.47, 95% CI 1.21 to 1.79); though the effect was unclear in interventions among women from ethnic minority groups (five studies; average RR 1.08, 95% CI 0.83 to 1.40) and aboriginal women (two studies; average RR 0.40, 95% CI 0.06 to 2.67). Importantly, pooled results demonstrated that women who received psychosocial interventions had an 18% reduction in preterm births (14 studies; average RR 0.82, 95% CI 0.70 to 0.96), and infants born with low birthweight (14 studies; average RR 0.82, 95% CI 0.71 to 0.94). There did not appear to be any adverse effects from the psychosocial interventions, and three studies measured an improvement in women's psychological wellbeing. Psychosocial interventions to support women to stop smoking in pregnancy can increase the proportion of women who stop smoking in late pregnancy, and reduce low birthweight and preterm births.
    Cochrane database of systematic reviews (Online) 10/2013; 10(10):CD001055. DOI:10.1002/14651858.CD001055.pub4 · 6.03 Impact Factor
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    ABSTRACT: Smoking during pregnancy is directly associated with numerous serious conditions, such as premature birth, low birth weight, and perinatal mortality. We quantitatively evaluated histological inflammatory alterations, oxidative damage by lipid peroxidation, the activity of the antioxidant enzymes superoxide dismutase (SOD) and catalase (CAT) in the lungs of mice exposed to cigarette smoke during pregnancy. Eight female and four male mice were mated for five days. Pregnant female mice were randomly allocated to the control group or to the cigarette smoke group (n = 8) in which they were exposed to 12 cigarettes per day in an exposure chamber, three times a day for 21 days. The control group (CG; n = 8) was kept in the exposure chamber for the same duration, but without exposure to cigarette smoke. Six newborn mice from both groups were weighed 24 hours after birth and then euthanized. Lung tissue was collected and subjected to histomorphometric and biochemical analyses. The cigarette smoke group showed a significant reduction in snout-vent length compared to the control group. Histomorphometric analysis indicated increased alveolar septal thickness and a larger alveolar lumen in mice exposed to cigarette smoke than in mice in the control group. We observed increased alveolar inflammatory infiltrate, decreased SOD activity, and significantly higher oxidative damage in the cigarette smoke group. Our data indicate that cigarette smoke exposure during pregnancy decreases body length at birth, changes lung tissue, and causes redox imbalance and histological damage in newborn mice.
    Experimental Lung Research 03/2014; 40(4). DOI:10.3109/01902148.2014.893383 · 1.41 Impact Factor
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    ABSTRACT: Background: Material or financial incentives are widely used in an attempt to precipitate or reinforce behaviour change, including smoking cessation. They operate in workplaces, in clinics and hospitals, and to a lesser extent within community programmes. In this third update of our review we now include trials conducted in pregnant women, to reflect the increasing activity and resources now targeting this high-risk group of smokers. Objectives: To determine whether incentives and contingency management programmes lead to higher long-term quit rates. Search methods: We searched the Cochrane Tobacco Addiction Group Specialised Register, with additional searches of MEDLINE, EMBASE, CINAHL and PsycINFO. The most recent searches were in December 2014, although we also include two trials published in 2015. Selection criteria: We considered randomised controlled trials, allocating individuals, workplaces, groups within workplaces, or communities to experimental or control conditions. We also considered controlled studies with baseline and post-intervention measures. We include studies in a mixed-population setting (e.g. community-, work-, institution-based), and also, for this update, trials in pregnant smokers. Data collection and analysis: One author (KC) extracted data and a second (JH-B) checked them. We contacted study authors for additional data where necessary. The main outcome measure in the mixed-population studies was abstinence from smoking at longest follow-up, and at least six months from the start of the intervention. In the trials of pregnant smokers abstinence was measured at the longest follow-up, and at least to the end of the pregnancy. Main results: Twenty-one mixed-population studies met our inclusion criteria, covering more than 8400 participants. Ten studies were set in clinics or health centres, one in Thai villages served by community health workers, two in academic institutions, and the rest in worksites. All but six of the trials were run in the USA. The incentives included lottery tickets or prize draws, cash payments, vouchers for goods and groceries, and in six trials the recovery of money deposited by those taking part. The odds ratio (OR) for quitting with incentives at longest follow-up (six months or more) compared with controls was 1.42 (95% confidence interval (CI) 1.19 to 1.69; 17 trials, [20 comparisons], 7715 participants). Only three studies demonstrated significantly higher quit rates for the incentives group than for the control group at or beyond the six-month assessment: One five-arm USA trial compared rewards- and deposit-based interventions at individual and group level, with incentives available up to USD 800 per quitter, and demonstrated a quit rate in the rewards groups of 8.1% at 12 months, compared with 4.7% in the deposits groups. A direct comparison between the rewards-based and the deposit-based groups found a benefit for the rewards arms, with an OR at 12 months of 1.76 (95% CI 1.22 to 2.53; 2070 participants). Although more people in this trial accepted the rewards programmes than the deposit programmes, the proportion of quitters in each group favoured the deposit-refund programme. Another USA study rewarded both participation and quitting up to USD 750, and achieved sustained quit rates of 9.4% in the incentives group compared with 3.6% for the controls. A deposit-refund trial in Thailand also achieved significantly higher quit rates in the intervention group (44.2%) compared with the control group (18.8%), but uptake was relatively low, at 10.5%. In the remaining trials, there was no clear evidence that participants who committed their own money to the programme did better than those who did not, or that contingent rewards enhanced success rates over fixed payment schedules. We rated the overall quality of the older studies as low, but with later trials (post-2000) more likely to meet current standards of methodology and reporting.Eight of nine trials with usable data in pregnant smokers (seven conducted in the USA and one in the UK) delivered an adjusted OR at longest follow-up (up to 24 weeks post-partum) of 3.60 (95% CI 2.39 to 5.43; 1295 participants, moderate-quality studies) in favour of incentives. Three of the trials demonstrated a clear benefit for contingent rewards; one delivered monthly vouchers to confirmed quitters and to their designated 'significant other supporter', achieving a quit rate in the intervention group of 21.4% at two months post-partum, compared with 5.9% among the controls. Another trial offered a scaled programme of rewards for the percentage of smoking reduction achieved over the course of the 12-week intervention, and achieved an intervention quit rate of 31% at six weeks post-partum, compared with no quitters in the control group. The largest (UK-based) trial provided intervention quitters with up to GBP 400-worth of vouchers, and achieved a quit rate of 15.4% at longest follow-up, compared to the control quit rate of 4%. Four trials confirmed that payments made to reward a successful quit attempt (i.e. contingent), compared to fixed payments for attending the antenatal appointment (non-contingent), resulted in higher quit rates. Front-loading of rewards to counteract early withdrawal symptoms made little difference to quit rates. Authors' conclusions: Incentives appear to boost cessation rates while they are in place. The two trials recruiting from work sites that achieved sustained success rates beyond the reward schedule concentrated their resources into substantial cash payments for abstinence. Such an approach may only be feasible where independently-funded smoking cessation programmes are already available, and within a relatively affluent and educated population. Deposit-refund trials can suffer from relatively low rates of uptake, but those who do sign up and contribute their own money may achieve higher quit rates than reward-only participants. Incentive schemes conducted among pregnant smokers improved the cessation rates, both at the end-of-pregnancy and post-partum assessments. Current and future research might continue to explore the scale, loading and longevity of possible cash or voucher reward schedules, within a variety of smoking populations.
    Cochrane database of systematic reviews (Online) 05/2015; 5:CD004307. DOI:10.1002/14651858.CD004307.pub5 · 6.03 Impact Factor