NCT03156660

Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: University of Tennessee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study aims to randomize 400 participants to 1 of 3 arms: a) a weight stability intervention prior to smoking cessation (Group 1); b) a weight loss intervention prior to smoking cessation (Group 2); or c) a self-guided weight management prior to cessation (Group 3) and to determine the efficacy of the interventions on preventing weight gain at 12 month follow-up. All 3 conditions receive a highly efficacious behavioral smoking cessation program and 6 months of varenicline pharmacotherapy (ChantixTM), the most efficacious medication for smoking cessation.

Detailed description

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, the investigators will determine whether two very promising methods of reducing postcessation weight gain, namely a weight stability intervention (based on the evidence-based Small Changes 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. The investigators will randomize 400 smokers to one of three arms: a) a weight stability intervention prior to cessation (Group 1); b) a weight loss intervention prior to cessation (Group 2), or c) a self-guided intervention prior to cessation (Group 3) 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 Group 1 and Group 2 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, the investigators will gather process data on mediators of treatment outcome via measures of treatment engagement (e.g., session attendance, varenicline utilization). The investigators 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.

Conditions

• Weight Change, Body
• Smoking Cessation

Interventions

Type	Name	Description
BEHAVIORAL	Weight gain prevention (Group 1)	Participants will be asked to keep their weight stable during the initial 8 weeks of the study. Intervention Components: 1. Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day). 2. Daily self-monitoring of steps and number of Small Changes 3. Daily weight self-monitoring on the BodyTraceTM e-scale 4. Fit Bit Alta activity trackers to self-monitor steps
BEHAVIORAL	Weight loss intervention (Group 2)	Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8. Intervention Components: 1. Tailored calorie and fat goals based on their baseline weight. 2. Daily dietary intake and physical activity self-monitoring using a website or app. 3. Daily weight self-monitoring on the BodyTraceTM e-scale 4. Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention 5. Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions 6. Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day 7. Fit Bit Alta activity trackers to self-monitor steps
BEHAVIORAL	Self-guided intervention (Group 3)	Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book. Intervention Components: 1. EatingWell Diet book. 2. Daily weight self-monitoring on the BodyTraceTM e-scale

Timeline

• Start date: 2017-11-30
• Primary completion: 2022-03-12
• Completion: 2022-03-12
• First posted: 2017-05-17
• Last updated: 2023-04-21
• Results posted: 2023-04-21

Locations

1 site across 1 country: United States