PRImary Care Strategies for Weight Management (PRISM) Study
Recruiting · NCT07288294 · Interventional (participants receive a specific treatment) · Lead sponsor: Rush University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
PRISM Program
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
- For randomization: discontinue their prescribed anti-obesity medication.
- Age 18+
Exclusion criteria
- Not fluent in English
- Diagnosis of diabetes (type 1 or type 2)
- Current or planned pregnancy
- Bariatric surgery in the past 2 years or planned bariatric surgery.
- Body mass index ≥60 kg/m2, due to increased injury risk with exercise
- Body weight ≥ 375 pounds (scale capacity with a margin for regain)
- No access to home WIFI or a smartphone with data available
- 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.)
- Concurrent engagement with other behavioral treatments for obesity (for randomized phase only).
- Medication obtained from online/compound pharmacies or prescription from specialty clinic without a prescription from primary care team at the time of enrollment
- Another member of the household is enrolled in the study
Where it is running
1 location listed across 1 US state.
- Rush University Medical Center - Chicago, Illinois, United States