Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273163
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-15
Brief Title:
Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N20 andor Noom a mobile application Group 2 N20 are associated with greater treatment adherence and satisfaction than usual care Group 3 N20 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None