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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07535892 on ClinicalTrials.gov