What this study is
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.
What's being tested
- PRISM Program
Intervention · BEHAVIORAL
This is a novel, remotely delivered, self-tailored intervention for post-anti-obesity medication discontinuation weight management. The program incorporates standard-of-care behavioral intervention strategies for weight control to improve routine self-weighing, dietary self-monitoring, and increasing physical activity. The program includes an enhanced focus on strategies to reduce food cue reactivity. The program includes six monthly one-on-one sessions between study staff and participants, asynchronous online check-ins weekly for 12 weeks, and bi-weekly for 12 weeks.
Study details
- Official title
- Primary-Care Strategies to Enhance Weight Management (PRISM) After Discontinuation of Anti-Obesity Medications
- Sponsor
- Rush University Medical Center
- Conditions
- Obesity
- Enrolling
- 214 people
- Starts
- 2026-06-04
- Est. completion
- 2028-04-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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+
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRush University Medical Center
Chicago, Illinois, United States
- Melissa Crane · Contact312-942-1282crane_lab@rush.edu
Recruiting
Study team
Sponsor
Rush University Medical Center
Study ID ORA#24011905
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.