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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273163
• Other study ID #: STU-2023-1168
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Carolyn Haskins, MS
• Phone: ?(469) 431-3992?
• Email: niche[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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).

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	UT Southwestern Nutrition Obesity Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incremental cost effective ratio (ICER)	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
Primary	Intervention Adherence	Adherence will be measured using the Perceived Behavior subscale (6-items) from the validated Treatment Adherence Perception Questionnaire (TAPQ).	4-months
Primary	Intervention Satisfaction	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	Percent weight loss maintained	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
Secondary	Diet quality	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