Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial
Abstract 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...
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doaj-d87a6ba66dcb4a3399406d3b2bbfbbd02020-11-24T22:12:51ZengBMCBMC Public Health1471-24582016-07-0116111210.1186/s12889-016-3231-6Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trialTerry Bush0Jennifer Lovejoy1Harold Javitz2Brooke Magnusson3Alula Jimenez Torres4Stacey Mahuna5Cody Benedict6Ken Wassum7Bonnie Spring8Alere Wellbeing (now Optum)Arivale, Inc. and University of Washington School of Public HealthSRI InternationalAlere Wellbeing (now Optum)Alere Wellbeing (now Optum)Alere Wellbeing (now Optum)Bill and Melinda Gates FoundationAlere Wellbeing (now Optum)Center for Behavior and Health, Feinberg School of Medicine, Northwestern UniversityAbstract 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, 2013http://link.springer.com/article/10.1186/s12889-016-3231-6SmokingWeight managementCombined treatmentSimultaneousSequentialQuitlines |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Terry Bush Jennifer Lovejoy Harold Javitz Brooke Magnusson Alula Jimenez Torres Stacey Mahuna Cody Benedict Ken Wassum Bonnie Spring |
spellingShingle |
Terry Bush Jennifer Lovejoy Harold Javitz Brooke Magnusson Alula Jimenez Torres Stacey Mahuna Cody Benedict Ken Wassum Bonnie Spring Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial BMC Public Health Smoking Weight management Combined treatment Simultaneous Sequential Quitlines |
author_facet |
Terry Bush Jennifer Lovejoy Harold Javitz Brooke Magnusson Alula Jimenez Torres Stacey Mahuna Cody Benedict Ken Wassum Bonnie Spring |
author_sort |
Terry Bush |
title |
Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial |
title_short |
Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial |
title_full |
Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial |
title_fullStr |
Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial |
title_full_unstemmed |
Comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial |
title_sort |
comparative effectiveness of adding weight control simultaneously or sequentially to smoking cessation quitlines: study protocol of a randomized controlled trial |
publisher |
BMC |
series |
BMC Public Health |
issn |
1471-2458 |
publishDate |
2016-07-01 |
description |
Abstract 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 |
topic |
Smoking Weight management Combined treatment Simultaneous Sequential Quitlines |
url |
http://link.springer.com/article/10.1186/s12889-016-3231-6 |
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