Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
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.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 5 March 2024
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Dallas, Texas, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 15 February 2024
  • First Submitted that Met QC Criteria 15 February 2024
  • First Posted 22 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 March 2024
  • Last Update Posted 8 March 2024
  • Last Verified March 2024