Clinical trial

PRImary Care Strategies for Weight Management (PRISM) Study

Recruiting now · Not applicable · 1 countries · Registry ID NCT07288294

Recruiting nowNot applicableInterventional

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

Recruitment rateBaseline

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

Acceptability of the Intervention3 and 6 months post randomization

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).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Rush University Medical Center🇺🇸 Chicago, Illinois, United States
Melissa CraneContact