PRImary Care Strategies for Weight Management (PRISM) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRISM Program.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Primary-Care Strategies to Enhance Weight Management (PRISM) After Discontinuation of Anti-Obesity Medications
Overview
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.
Detailed description
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.
Interventions
- 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, asyn
Primary outcome measures
- Recruitment rate [Time frame: Baseline]
- Acceptability of the Intervention [Time frame: 3 and 6 months post randomization]
Secondary outcome measures (2)
- Medication adherence duration questions [Time frame: From consent to reported discontinuation, up to 22 months]
- Reasons for Discontinuation questions [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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.
- For randomization: discontinue their prescribed anti-obesity medication.
- Age 18+
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rush University Medical Center — Chicago
Identifiers
NCT: NCT07288294 · ORA#24011905