NCT06273163

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Medically tailored meals	Medically tailored meals are nutritious meals formulated for weight wellness.
BEHAVIORAL	Noom®	Noom® is a subscription-based mobile application used to support healthy eating and exercise behavior change.
OTHER	Usual care	Care is provided at the discretion of the individual provider (e.g., usual care).

Timeline

• Start date: 2024-03-05
• Primary completion: 2025-08-05
• Completion: 2025-08-05
• First posted: 2024-02-22
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States