PRImary Care Strategies for Weight Management (PRISM) Study

NCT ID: NCT07288294

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2028-04-01

Brief 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.

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PRISM Program

Group Type: EXPERIMENTAL

PRISM Program

Intervention Type: 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.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PRISM 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Melissa M Crane, PhD

Role: CONTACT

Phone: 312-942-1282

Email: melissa_m_crane@rush.edu

Other Identifiers

ORA#24011905

Identifier Type: -

Identifier Source: org_study_id