Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation

Last updated: October 13, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Terminated

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Usual care

Noom®

Medically tailored meals

Clinical Study ID

NCT06273163
STU-2023-1168
  • Ages > 18
  • All Genders

Study Summary

Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • 18 years of age or older;

  • ability to read, write, and speak English;

  • ability to provide informed consent;

  • greater than 10% GLP-1 Receptor Agonist induced weight loss

  • less than 30-days since GLP-1 Receptor Agonist cessation;

  • willing to participate.

Exclusion

Exclusion criteria:

  • major psychiatric illness or substance misuse that could impair ability toparticipate;

  • presence of a medical condition or dietary restriction precluding eating study mealsor weight loss (e.g., medical condition requiring liquid diet, pregnancy, eatingdisorder);

  • participation in a study or program involving medically tailored meals or Noom®within the past 12-months.

Study Design

Total Participants: 39
Treatment Group(s): 3
Primary Treatment: Usual care
Phase:
Study Start date:
March 05, 2024
Estimated Completion Date:
August 05, 2025

Study Description

In the proposed study the investigators will execute a pilot randomized controlled trial to identify whether medically tailored meals (MTM, Group 1, N=20) and/or Noom®, a mobile application (Group 2, N=20) are associated with greater treatment adherence and satisfaction than usual care (Group 3, N=20) after GLP-1 Receptor Agonist cessation. The investigators will enroll adults 18 and older that have lost more than 10% of their bodyweight taking GLP-1 Receptor Agonist and ceased treatment within the past 30-days. For four-months, Group 1 will receive 40 MTM per month, Group 2 will receive a Noom® subscription, and Group 3 will receive lifestyle counseling per standard of care.

Connect with a study center

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

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