PRImary Care Strategies for Weight Management (PRISM) Study

NCT07288294 | Not Yet Recruiting

• 1 other identifier: ORA#24011905
• Study Type: interventional
• Target: 214
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Recruitment rate

  The recruitment rate will be defined as the number of participants randomized into the clinical trial per month.

  Baseline

• Acceptability of the Intervention

  Self-reported Likert scale items will assess the overall satisfaction with the program, the likelihood participants would recommend the program to others, and their satisfaction with individual treatment components (e.g., the online check-ins).

  3 and 6 months post randomization

Secondary Outcomes (2)

• Medication adherence duration questions

  From consent to reported discontinuation, up to 22 months

• Reasons for Discontinuation questions

  Baseline

Other Outcomes (9)

• Recruitment efficiency

  Baseline

• Retention to the study

  6 months post-randomization

• Intervention adherence

  Randomization to 6 months

Study Arms (2)

PRISM Program

EXPERIMENTAL

Behavioral: PRISM Program

Usual Care

NO INTERVENTION

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

Interventions

PRISM Program 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.

PRISM Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obesity (body mass index ≥30 kg/m2 or ≥27 kg/m2 with obesity-related comorbidity or self-identified Asian race)
• 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.
• For randomization: discontinue their prescribed anti-obesity medication.
• Age 18+

You may not qualify 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

Sponsors & Collaborators

• Rush University Medical Center: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Melissa M Crane, PhD

CONTACT

312-942-1282; melissa_m_crane@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This project is a randomized feasibility study with a run-in period

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 17, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share