PRImary Care Strategies for Weight Management (PRISM) Study
Sponsored by Rush University Medical Center
About this study
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.
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.
Where this study is enrolling
- I'm interested
Rush University Medical Center
Chicago, Illinois
Who can participate
Inclusion criteria
- ✓1. 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
- ✕1. 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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.