Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
University of Alabama at Birmingham
Summary
This study is a single-site, pilot randomized factorial trial designed to evaluate the feasibility, acceptability, participant perceptions and preliminary effects of a multi-component behavioral intervention to support weight loss maintenance following discontinuation of GLP-1 and other anti-obesity medications. The intervention includes a standardized 10-week foundational weight loss maintenance program combined with candidate support components, including medically tailored meals, YMCA membership, and a structured mind-based program. Participants will be randomized using a 2 × 2 × 2 factorial design and followed for six months. Findings from this pilot study will inform optimization of a scalable intervention for future clinical trials.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 years or older * Loss of ≥15% of initial body weight using anti-obesity medication * Discontinued anti-obesity medication within the past 4 weeks or planning to discontinue prior to randomization * ≤3 kg weight regain within the past 3 months * Willing and able to participate in a 6-month behavioral intervention, including a 10-week foundational program * Willing to complete study assessments at baseline, 3 months, and 6 months, including required in-person visits * Medical clearance for participation in moderate physical activity, dietary modification, and mind-b…
Interventions
- BehavioralWeight Loss Maintenance Program (Foundational)
All participants will receive a standardized 10-week foundational weight loss maintenance program designed to address three key domains: food, physical activity, and mind-based practices. This foundational program is intended to support the transition from active weight loss to long-term weight maintenance.
- BehavioralMom's Meals
Medically tailored meals
- BehavioralYMCA Membership
YMCA membership to support physical activity
- BehavioralSKY Meditation Program
The SKY Meditation program to support mind-based practices
Location
- University of Alabama at BirminghamBirmingham, Alabama