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PRImary Care Strategies for Weight Management (PRISM) Study

PRImary Care Strategies for Weight Management (PRISM) Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details
    Obesity

NCT07288294

Rush University Medical Center

27 June 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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