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

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Other: Medically tailored meals; Behavioral: Noom®; Other: Usual care

• Registration Number: NCT06273163
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-22
• Study Start: 2024-03-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medically tailored meals	Usual care	Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months.
Medically tailored meals	Medically tailored meals	Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months.
Noom®	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.
Noom®	Usual care	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.
Usual care	Usual care	Participants will receive usual care from their provider.

Primary Outcome Measures

Name	Time	Method
Intervention Satisfaction	4-months	The Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to measure satisfaction, and be adapted for the interventions understudy. Responses are provided on a 7-point Likert scale ranging from extremely satisfied to extremely dissatisfied. Scores are then transformed to a 0-100 scale with a higher score indicating greater treatment satisfaction.
Intervention Adherence	4-months	Adherence will be measured using the Perceived Behavior subscale (6-items) from the validated Treatment Adherence Perception Questionnaire (TAPQ).

Secondary Outcome Measures

Name	Time	Method
Percent weight loss maintained	4-months	The electronic health record will be used to determine the participants' weight prior to and at the end of GLP-1 Receptor Agonist treatment to determine the percent of bodyweight lost on GLP-1 Receptor Agonist. Weight will be measured using a Bluetooth scale pre- and post-intervention to calculate the percent of weight loss maintained at the end of the study.
Diet quality	4-months	Healthy eating index-2015 (HEI-2015), scored according to National Cancer Institute (NCI) guidelines from 0-100, with 0 indicating no intake of nutritious foods and 100 indicating higher intake of nutritious food.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States