While smoking cessation leads to significant improvements in mortality and morbidity, weight gain post- cessation partially attenuates this benefit. Furthermore, concerns about postcessation weight gain are common and are often cited as a reason to delay cessation attempts. In addition, postcessation weight gain is associated with smoking relapse. Thus, although the health benefits of smoking cessation outweigh the negative impact of weight gain, ideally there would be intervention ?packages? that would not require that people choose between smoking cessation and nontrivial weight gain. Thus, in the proposed study, we will determine whether two very promising methods of reducing postcessation weight gain, namely a weight stability intervention (based on the evidence-based Stability Skills First intervention) versus a weight loss intervention (based on the evidence-based Look AHEAD intensive lifestyle intervention) followed by a smoking cessation intervention are efficacious for reducing postcessation weight gain. We will randomize 400 smokers to one of three arms: a) a weight stability intervention prior to cessation (STABLE); b) a weight loss intervention prior to cessation (LOSS), or c) a bibliotherapy comparison condition prior to cessation (BIBLIO) and to determine the efficacy of the interventions on preventing weight gain at 12 month follow-up. All three conditions receive a highly efficacious in-person smoking cessation behavioral intervention and six months of Varenicline (ChantixTM) pharmacotherapy. Those participants randomized to the STABLE and LOSS conditions will receive monthly booster weight management sessions, after completing the behavioral smoking cessation intervention. The primary outcomes will be weight change and smoking cessation at 12 month follow-up. In addition, we will gather process data on mediators of treatment outcome via measures of treatment engagement (e.g., session attendance, varenicline utilization). We will be able to determine whether a weight stability intervention or a weight loss intervention is efficacious in reducing post-cessation weight gain. The intervention results, if successful, could be disseminated and make a significant contribution towards curtailing obesity in this vulnerable population.

Public Health Relevance

Although the health benefits of smoking cessation outweigh the negative impact of weight gain, ideally there would be intervention ?packages? that would not require that people choose between smoking cessation and nontrivial weight gain. The goal of the project is to determine whether two very promising methods of reducing postcessation weight gain, namely a weight stability intervention (based on the evidence-based Stability Skills First intervention) versus a weight loss intervention (based on the evidence-based Look AHEAD intensive lifestyle intervention) followed by a smoking cessation intervention are efficacious for reducing postcessation weight gain at 12 month follow-up in comparison to a condition that receives a weight management book prior to cessation. All three conditions receive a highly efficacious in-person smoking cessation behavioral intervention and 6 months of varenicline (ChantixTM) pharmacotherapy.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK107747-05
Application #
9971519
Study Section
Psychosocial Risk and Disease Prevention Study Section (PRDP)
Program Officer
Kuczmarski, Robert J
Project Start
2016-09-05
Project End
2021-06-30
Budget Start
2020-07-01
Budget End
2021-06-30
Support Year
5
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Tennessee Health Science Center
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
941884009
City
Memphis
State
TN
Country
United States
Zip Code
38103
Salgado GarcĂ­a, Francisco I; Derefinko, Karen J; Bursac, Zoran et al. (2018) Fit & quit: An efficacy trial of two behavioral post-cessation weight gain interventions. Contemp Clin Trials 76:31-40