Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
October 13, 2025 updated by: Kelseanna Hollis-Hansen, University of Texas Southwestern Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Medically tailored meals
Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months.
|
Medically tailored meals are nutritious meals formulated for weight wellness.
Care is provided at the discretion of the individual provider (e.g., usual care).
|
|
Experimental: 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.
|
Care is provided at the discretion of the individual provider (e.g., usual care).
Noom® is a subscription-based mobile application used to support healthy eating and exercise behavior change.
|
|
Placebo Comparator: Usual care
Participants will receive usual care from their provider.
|
Care is provided at the discretion of the individual provider (e.g., usual care).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Adherence
Time Frame: 4-months
|
Adherence will be measured using the Perceived Behavior subscale (6-items) from the validated Treatment Adherence Perception Questionnaire (TAPQ).
|
4-months
|
|
Intervention Satisfaction
Time Frame: 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.
|
4-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet quality
Time Frame: 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.
|
4-months
|
|
Percent weight loss maintained
Time Frame: 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.
|
4-months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incremental cost effective ratio (ICER)
Time Frame: 4-months
|
Incremental cost effectiveness ratios (ICER) will be calculated as the difference in cost to implement each intervention divided by 1) the increase in HEI score and 2) percent weight loss maintained.
|
4-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kelseanna Hollis-Hansen, PhD, MPH, UT Southwestern Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2024
Primary Completion (Actual)
August 5, 2025
Study Completion (Actual)
August 5, 2025
Study Registration Dates
First Submitted
February 15, 2024
First Submitted That Met QC Criteria
February 15, 2024
First Posted (Actual)
February 22, 2024
Study Record Updates
Last Update Posted (Estimated)
October 15, 2025
Last Update Submitted That Met QC Criteria
October 13, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2023-1168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.