PRImary Care Strategies for Weight Management (PRISM) Study

Rush

Status: Begins enrollment this month

Conditions: Obesity

Treatments: Behavioral: PRISM Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07288294

ORA#24011905

Details and patient eligibility

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.

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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Obesity (body mass index ≥30 kg/m2 or ≥27 kg/m2 with obesity-related comorbidity or self-identified Asian race)
2. For run-in: prescribed liraglutide, semaglutide, or tirzepatide or newer medication approved by the FDA for long-term use for obesity treatment 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.
3. For randomization: discontinue their prescribed anti-obesity medication.
4. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups

PRISM Program

Experimental group

Treatment:

Behavioral: PRISM Program

Usual Care

No Intervention group

Description:

Participants will continue to receive their regular, usual primary care.