RecruitingNot ApplicableNCT07288294

PRImary Care Strategies for Weight Management (PRISM) Study

Primary-Care Strategies to Enhance Weight Management (PRISM) After Discontinuation of Anti-Obesity Medications

Sponsor

Rush University Medical Center

Enrollment

214 participants

Start Date

Jun 2, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria11

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

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Interventions

BEHAVIORALPRISM Program

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.