Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

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

64 Participants
are divided into 8 treatment groups

8

Treatment groups

See 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