PRImary Care Strategies for Weight Management (PRISM) Study (PRISM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: PRISM Program

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa M Crane, PhD; Phone Number: 312-942-1282; Email: melissa_m_crane@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRISM Program	Behavioral: 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.
No Intervention: Usual Care; Participants will continue to receive their regular, usual primary care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence duration questions	A published measure will be used to assess adherence throughout the run-in period. These questions will be asked bi-weekly to assess adherence with minimal participant burden.	From consent to reported discontinuation, up to 22 months
Reasons for Discontinuation questions	A published measure will be used to assess reasons for discontinuation throughout the run-in period. These items will be asked only if participants indicate nonadherence.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment efficiency	Recruitment efficiency will be defined as the days between the participant's last AOM dose and the date of randomization into the trial.	Baseline
Retention to the study	Retention to the study will be defined as an observed weight assessed during the 6-month assessment period.	6 months post-randomization
Intervention adherence	Intervention adherence will be defined as the number of one-on-one intervention sessions completed (out of 6 possible) and the number of online check-ins completed (out of 16).	Randomization to 6 months
Percent weight change	Weight data for outcome assessments (0, 3, and 6 months) will be collected remotely.	3 and 6 months post-randomization
Adherence to dietary self-monitoring	Active treatment arm only: portion of days adherent to self-monitoring recommendations	Randomization to 6 months
Physical activity	Active treatment arm only: wearable tracking device will monitor their steps per day and minutes of medium and high-intensity activity as determined by the Fitbit algorithm.	Randomization to 6 months
Self-weighing frequency	A smart scale will be used to collect the frequency of self-weighing behavior. Participants will consent to the electronic scale being used to monitor their weighing behavior. Staff will monitor the days per week of recorded weights and the value of the weights to examine weighing and weight trends.	Randomization to 6 months
Intervention staff time	Staff will track the time spent conducting and scheduling intervention contacts, including time related to the one-on-one sessions and any additional support provided to participants.	Randomization to 6 months
Trial protocol staff time	Staff will track their time conducting recruitment efforts, consent visits, and conducting and scheduling assessment appointments.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: ORA#24011905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No