About this trial
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 criteria
Qualifiers
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
Disqualifiers
Medical conditions that would preclude safe participation in physical activity, dietary changes, or mind-based practices (e.g., unstable cardiovascular disease, uncontrolled hypertension, severe orthopedic limitations, or seizure disorders not medically managed)
Active psychiatric conditions that would interfere with participation or safety (e.g., untreated major depression, active substance use disorder, or psychosis)
Pregnancy, breastfeeding, or plans to become pregnant during the study period
Current participation in another structured weight loss or weight maintenance program
Trial design
Treatments tested in this trial
- Weight Loss Maintenance Program (Foundational)
- Mom's Meals
- YMCA Membership
- SKY Meditation Program
Treatment groups
8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator