PRImary Care Strategies for Weight Management (PRISM) Study
Purpose
The goal of this clinical trial pilot is to determine the feasibility of an intervention to enhance weight management in patients who have stopped taking anti-obesity/weight management medications in primary care. The main questions it aims to answer are: - Can patients be recruited into the study efficiently? - Is the program acceptable to patients? - Can the study be conducted efficiently? The new program will be compared to usual care.
Condition
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- For run-in: prescribed liraglutide, semaglutide, or tirzepatide or newer medication approved by the FDA for long-term use for obesity treatment for the purpose of weight managment by a primary care provider at Rush University System for Health and have received at least one dose of the medication concurrent with enrollment in the study. 2. For randomization: discontinue their prescribed anti-obesity medication. 3. Age 18+
Exclusion Criteria
- Not fluent in English 2. Diagnosis of diabetes (type 1 or type 2) 3. Current or planned pregnancy 4. Bariatric surgery in the past 2 years or planned bariatric surgery. 5. Body mass index ≥60 kg/m2, due to increased injury risk with exercise 6. Body weight ≥ 375 pounds (scale capacity with a margin for regain) 7. No access to home WIFI or a smartphone with data available 8. Medical contraindications to treatment, including significant cognitive impairment, active substance abuse based on the World Health Organization's ASSIST screener, or serious medical illness (e.g., stage 3 or 4 heart failure, cancer, renal failure, etc.) 9. Concurrent engagement with other behavioral treatments for obesity (for randomized phase only). 10. Medication obtained from online/compound pharmacies or prescription from specialty clinic without a prescription from primary care team at the time of enrollment 11. Another member of the household is enrolled in the study
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This project is a randomized feasibility study with a run-in period
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PRISM Program |
This is a novel, remotely delivered, self-tailored intervention for post-anti-obesity medication discontinuation weight management. |
|
|
No Intervention Usual Care |
Participants will continue to receive their regular, usual primary care. |
|
Recruiting Locations
Chicago, Illinois 60130
More Details
- Status
- Recruiting
- Sponsor
- Rush University Medical Center
Detailed Description
The goal of this clinical trial pilot is to determine the feasibility of an intervention to enhance weight management in patients who have stopped taking anti-obesity/weight management medications in primary care. The main questions it aims to answer are: - Can patients be recruited into the study efficiently? - Is the program acceptable to patients? - Can the study be conducted efficiently? The new program will be compared to usual care. Participants will be asked to 1) complete short surveys about their medication use while taking the weight management medication, 2) complete online visits using study-provided scales, and 3) complete video visits with study staff monthly and online check-ins weekly, if assigned to the active treatment group.