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NCT07535892
Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
Conditions: Weight Loss, GLP - 1, Weight Loss Maintenance, Obesity & Overweight
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham Birmingham Alabama
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 Criteria
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
Source: ClinicalTrials.gov (NCT07535892). StuddyBuddy aggregates publicly available trial information.