Clinical trial NCT06273163: Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
Official title: Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Glucagon-Like Peptide-1 Receptor Agonists
Body Weight Maintenance
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: UT Southwestern Nutrition Obesity Research Center
First posted: 2024-02-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized repeated measures between-subjects design
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Adherence
timeFrame: 4-months
measure: Intervention Satisfaction
timeFrame: 4-months
Secondary outcomes:
measure: Percent weight loss maintained
timeFrame: 4-months
measure: Diet quality
timeFrame: 4-months
Other outcomes:
measure: Incremental cost effective ratio (ICER)
timeFrame: 4-months
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Kelseanna Hollis-Hansen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: