Simultaneous vs. sequential treatment for smoking and weight management in tobacco quitlines: 6 and 12 month outcomes from a randomized trial.

BACKGROUND: Smoking cessation often results in weight gain which discourages many smokers from quitting and can increase health risks. Treatments to reduce cessation-related weight gain have been tested in highly controlled trials of in-person treatment, but have never been tested in a real-world setting, which has inhibited dissemination. METHODS: The Best Quit Study (BQS) is a replication and "real world" translation using telephone delivery of a prior in-person efficacy trial. DESIGN: randomized control trial in a quitline setting. Eligible smokers (n = 2540) were randomized to the standard 5-call quitline intervention or quitline plus simultaneous or sequential weight management. Regression analyses tested effectiveness of treatments on self-reported smoking abstinence and weight change at 6 and 12 months. RESULTS: Study enrollees were from 10 commercial employer groups and three state quitlines. Participants were between ages 18-72, 65.8% female, 68.2% white; 23.0% Medicaid-insured, and 76.3% overweight/obese. The follow-up response rate was lower in the simultaneous group than the control group at 6 months (p = 0.01). While a completers analysis of 30-day point prevalence abstinence detected no differences among groups at 6 or 12 months, multiply imputed abstinence showed quit rate differences at 6 months for:simultaneous (40.3%) vs. sequential (48.3%), p = 0.034 and simultaneous vs. control (44.9%), p = 0.043. At 12 months, multiply imputed abstinence, was significantly lower for the simultaneous group (40.7%) vs. control (46.0%), p < 0.05 and vs. sequential (46.3%), p < 0.05. Weight gain at 6 and 12 months was minimal and not different among treatment groups. The sequential group completed fewer total calls (3.75) vs. control (4.16) and vs. simultaneous group (3.83), p = 0.01, and fewer weight calls (0.94) than simultaneous (2.33), p < 0.0001. The number of calls completed predicted 30-day abstinence, p < 0.001, but not weight outcomes. DISCUSSION: This study offers a model for evaluating population-level public health interventions conducted in partnership with tobacco quitlines. CONCLUSIONS: Simultaneous (vs. sequential) delivery of phone/web weight management with cessation treatment in the quitline setting may adversely affect quit rate. Neither a simultaneous nor sequential approach to addressing weight produced any benefit on suppressing weight gain. This study highlights the need and the challenges of testing intensive interventions in real-world settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01867983 . Registered: May 30, 2013.

Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial.

BACKGROUND: Prevalence of multiple health risk behaviors is growing, and obesity and smoking are costly. Weight gain associated with quitting smoking is common and can interfere with quit success. Efficacy of adding weight management to tobacco cessation treatment has been tested with women in group sessions over an extended period of time, but has never been tested in real-world settings with men and women seeking help to quit. This paper describes the Best Quit study which tests the effectiveness of delivering tobacco and weight control interventions via existing quitline infrastructures. METHODS: Eligible and consenting smokers (n = 2550) who call a telephone quitline will be randomized to one of three groups; the standard quitline or standard quitline plus a weight management program added either simultaneously or sequentially to the tobacco program. The study aims to test: 1) the effectiveness of the combined intervention on smoking cessation and weight, 2) the cost-effectiveness of the combined intervention on cessation and weight and 3) theoretically pre-specified mediators of treatment effects on cessation: reduced weight concerns, increased outcome expectancies about quitting and improved self-efficacy about quitting without weight gain. Baseline, 6 month and 12 month data will be analyzed using multivariate statistical analyses and groups will be compared on treatment adherence, quit rates and change in weight among abstinent participants. To determine if the association between group assignment and primary outcomes (30-day abstinence and change in weight at 6 months) is moderated by pre-determined baseline and process measures, interaction terms will be included in the regression models and their significance assessed. DISCUSSION: This study will generate information to inform whether adding weight management to a tobacco cessation intervention delivered by phone, mail and web for smokers seeking help to quit will help or harm quit rates and whether a simultaneous or sequential approach is better at increasing abstinence and reducing weight gain post quit. If proven effective, the combined intervention could be disseminated across the U.S. through quitlines and could encourage additional smokers who have not sought cessation treatment for fear of gaining weight to make quit attempts. TRIAL REGISTRATION: Clinicaltrials.gov NCT01867983 . Registered: May 30, 2013.

Race differences in predictors of weight gain among a community sample of smokers enrolled in a randomized controlled trial of a multiple behavior change intervention.

African Americans have disproportionate rates of post-cessation weight gain compared to non-Hispanic whites, but few studies have examined this weight gain in a multiracial sample of smokers receiving evidence-based treatment in a community setting. We examined race differences in short-term weight gain during an intervention to foster smoking cessation plus weight management. Data were drawn from the Best Quit Study, a randomized controlled trial conducted via telephone quitlines across the U.S. from 2013 to 2017. The trial tested the effects on cessation and weight gain prevention of adding a weight control intervention either simultaneously with or sequentially after smoking cessation treatment. African Americans (n = 665) and whites (n = 1723) self-reported smoking status and weight during ten intervention calls. Random effects longitudinal modeling was used to examine predictors of weight change over the intervention period (average 16 weeks). There was a significant race × treatment effect; in the simultaneous group, weight increased for African Americans at a faster rate compared to whites (b = 0.302, SE = 0.129, p < 0.05), independent of smoking status, age, baseline obesity, and education. After stratifying the sample, the effect of treatment group differed by race. Education level attenuated the rate of weight gain for African Americans in the simultaneous group, but not for whites. African Americans receiving smoking and weight content simultaneously gained weight faster than whites in the same group; however, the weight gain was slower for African Americans with higher educational attainment. Future studies are needed to understand social factors associated with treatment receptivity that may influence weight among African American smokers.

Support person interventions to increase use of quitline services among racially diverse low-income smokers: A pilot study.

INTRODUCTION: Social support from nonsmokers may have a role in prompting smokers to use evidence-based cessation treatment. Prior studies found that an intervention for nonsmoking support persons (SPs) was effective for promoting smokers' use of free, state quitline services. This pilot study adapted and assessed feasibility of this intervention for a racially diverse, low-income population. METHODS: Single group, non-randomized design enrolling SP-smoker dyads with low income status enrolled in one of three study "waves" of 10 pairs each. Participants were recruited using flyers and in-person outreach methods. The SP intervention included a 1-session coaching call and written materials; study waves 2 and 3 also included text messaging and a monetary incentive for smokers who used quitline services. Using content analysis, the intervention was iteratively adapted based on SP feedback. Baseline measures assessed socio-demographics, dyad and tobacco use characteristics. Follow-up assessments were conducted among SPs at 1-month follow-up and among smokers at 3-months follow-up. Feasibility indicators were recruitment, retention, and SP intervention acceptability and adherence. Secondary outcomes were smokers' use of any quitline service verified by quitline staff and 7-day, point prevalence, biochemically verified smoking abstinence at 3 months. RESULTS: Recruitment of 30 dyads was feasible; in-person recruitment methods were the most successful. SPs who completed follow-up assessments found the intervention acceptable, suggesting only minor content modifications, and they perceived the quitline information as novel. But the study had some feasibility challenges (e.g., SP coaching call completion: 60% and SP study retention: 53%). At 3 months, 2 smokers (7%) had used any quitline service and 13% were biochemically confirmed smoking abstinent. CONCLUSIONS: This pilot study demonstrated feasibility of recruiting SP-smoker dyads from diverse, low-income communities. While the intervention was well received, its delivery was not feasible in this population. Results suggest that further consumer adaptation of the intervention is needed among both SPs and smokers.

IMPLEMENTATION, RECRUITMENT AND BASELINE CHARACTERISTICS: A RANDOMIZED TRIAL OF COMBINED TREATMENTS FOR SMOKING CESSATION AND WEIGHT CONTROL.

BACKGROUND: Two-thirds of treatment-seeking smokers are obese or overweight. Most smokers are concerned about gaining weight after quitting. The average smoker experiences modest post-quit weight gain which discourages many smokers from quitting. Although evidence suggests that combined interventions to help smokers quit smoking and prevent weight gain can be helpful, studies have not been replicated in real world settings. METHODS: This paper describes recruitment and participant characteristics of the Best Quit Study, a 3-arm randomized controlled trial testing tobacco cessation treatment alone or combined with simultaneous or sequential weight management. Study participants were recruited via tobacco quitlines from August 5, 2013 to December 15, 2014. RESULTS: Statistical analysis on baseline data was conducted in 2015/2016. Among 5,082 potentially eligible callers to a tobacco quitline, 2,540 were randomized (50% of eligible). Compared with individuals eligible but not randomized, those randomized were significantly more likely to be female (65.7% vs 54.5%, p<.01), overweight or obese (76.3% vs 62.5%, p<.01), more confident in quitting (p<.01), more addicted (first cigarette within 5 minutes: 50.0% vs 44.4%, p<.01), and have a chronic disease (28.6% vs. 24.4%, p<.01). Randomized groups were not statistically significantly different on demographics, tobacco or weight variables. Two-thirds of participants were female and white with a mean age of 43. CONCLUSIONS: Adding weight management interventions to tobacco cessation quitlines was feasible and acceptable to smokers. If successful for cessation and weight outcomes, a combined intervention may provide a treatment approach for addressing weight gain with smoking cessation through tobacco quitlines.