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

The University of Texas System (UT)

Status: Terminated

Conditions: Obesity

Treatments: Behavioral: Noom®; Other: Usual care; Other: Medically tailored meals

Study type: Interventional

Funder types: Other

Identifiers

NCT06273163

STU-2023-1168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 3 patient groups, including a placebo group

Medically tailored meals

Experimental group

Description:

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

Treatment:

Other: Medically tailored meals

Other: Usual care

Noom®

Experimental group

Description:

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.

Treatment:

Other: Usual care

Behavioral: Noom®

Usual care

Placebo Comparator group

Description:

Participants will receive usual care from their provider.

Treatment:

Other: Usual care