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

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

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.

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-based practices
• Access to reliable internet for participation in virtual sessions and remote data collection
• English fluency sufficient to complete study procedures
• Able to provide informed consent

Exclusion Criteria:

• 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
• Continued use of anti-obesity medication after randomization
• Plans to initiate medications or treatments that may significantly affect body weight during the study period
• Inability to attend required study visits or participate in virtual sessions and remote data collection
• Any condition that, in the opinion of the investigators, would compromise participant safety or study integrity