Efficacy of Two Novel Behavioral Post-cessation Weight Gain Interventions

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.

Conditions

• Weight Change, Body
• Smoking Cessation

Interventions

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

Sponsors & Collaborators

• Mayo Clinic

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Tennessee

  lead OTHER

Principal Investigators

• Rebecca Krukowski, PhD · University of Tennessee

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-11-30

Primary Completion

2022-03-12

Completion

2022-03-12

Countries

• United States

Study Locations