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

<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>Clinicaltrials.gov NCT01867983 . Registered: May 30, 2013. [ABSTRACT FROM AUTHOR]