Recruiting

Weight Management

Sponsor:

Rush University Medical Center

Code:

NCT07288294

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PRISM Program

Study Details

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.

Conditions

Obesity

Study ID

NCT07288294

Start date

Jun 4, 2026

Status verified date

Jul, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

214 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PRISM Program

This is a novel, remotely delivered, self-tailored intervention for post-anti-obesity medication discontinuation weight management.

no intervention: Usual Care

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

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.

Primary outcome measure

  • Recruitment rate [ Time Frame: Baseline ]
  • Acceptability of the Intervention [ Time Frame: 3 and 6 months post randomization ]

Central Contacts and Locations

Central contacts

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60130

Contacts

More Information

Sponsor

Rush University Medical Center

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-07-09.