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PRImary Care Strategies for Weight Management (PRISM) Study

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This pilot study tests whether a new weight management program is practical to run and acceptable to patients. It is for adults who stop taking prescribed weight management medicine through primary care. The study compares the new program with usual care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • To enter the first study phase, have a prescription from a Rush University System for Health primary care provider for weight management. Medicines include liraglutide, semaglutide, tirzepatide, or a newer FDA-approved medicine for long-term obesity treatment.
  • Have taken at least one dose of the medicine when joining the study.
  • To enter the phase where you are assigned to a study group, stop taking your prescribed weight management medicine.

Who can't join

  • Not fluent in English, or have type 1 or type 2 diabetes.
  • Are pregnant or plan to become pregnant; or had weight-loss surgery in the past 2 years or plan to have it.
  • Have a body mass index (BMI, a measure based on height and weight) of 60 or higher, or weigh 375 pounds or more.
  • Have no access to home Wi-Fi or a smartphone with data.
  • Have a health problem that makes treatment unsafe, such as major thinking or memory problems, current substance abuse found by a screening test, or a serious illness such as advanced heart failure, cancer, or kidney failure.
  • Take part in another behavior-change treatment for obesity during the phase where you are assigned to a study group.
  • Get the medicine from an online or compounding pharmacy; or get it from a specialty clinic without a primary care team prescription when joining.
  • Have another person in your household already enrolled in the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

IL