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

NCT ID: NCT06273163

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2025-08-05

Brief 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.

Detailed 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Medically tailored meals

Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months.

Group Type: EXPERIMENTAL

Medically tailored meals

Intervention Type: OTHER

Medically tailored meals are nutritious meals formulated for weight wellness.

Usual care

Intervention Type: OTHER

Care is provided at the discretion of the individual provider (e.g., usual care).

Noom®

Participants will receive a paid Noom® subscription for four-months. Noom® is a subscription-based mobile application that provides food intake and exercise tracking and uses principles from psychology to motivate behavior change.

Group Type: EXPERIMENTAL

Noom®

Intervention Type: BEHAVIORAL

Noom® is a subscription-based mobile application used to support healthy eating and exercise behavior change.

Usual care

Intervention Type: OTHER

Care is provided at the discretion of the individual provider (e.g., usual care).

Usual care

Participants will receive usual care from their provider.

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: OTHER

Care is provided at the discretion of the individual provider (e.g., usual care).

Interventions

Medically tailored meals

Medically tailored meals are nutritious meals formulated for weight wellness.

Intervention Type: OTHER

Noom®

Noom® is a subscription-based mobile application used to support healthy eating and exercise behavior change.

Intervention Type: BEHAVIORAL

Usual care

Care is provided at the discretion of the individual provider (e.g., usual care).

Intervention Type: OTHER

Eligibility Criteria

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 Criteria

• major psychiatric illness or substance misuse that could impair ability to participate;
• presence of a medical condition or dietary restriction precluding eating study meals or weight loss (e.g., medical condition requiring liquid diet, pregnancy, eating disorder);
• participation in a study or program involving medically tailored meals or Noom® within the past 12-months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UT Southwestern Nutrition Obesity Research Center

UNKNOWN

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kelseanna Hollis-Hansen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelseanna Hollis-Hansen, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2023-1168

Identifier Type: -

Identifier Source: org_study_id