Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation
NCT07535892 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2026-04-17
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.
Conditions
- Weight Loss
- GLP - 1
- Weight Loss Maintenance
- Obesity & Overweight
Interventions
- BEHAVIORAL
-
Weight 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.
- BEHAVIORAL
-
Mom's Meals
Medically tailored meals
- BEHAVIORAL
-
YMCA Membership
YMCA membership to support physical activity
- BEHAVIORAL
-
SKY Meditation Program
The SKY Meditation program to support mind-based practices
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Holly Wyatt, MD · University of Alabama at Birmingham
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2028-11-30
- Completion
- 2029-02-28
Countries
- United States
Study Locations
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