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NCT Number: NCT07288294

PRImary Care Strategies for Weight Management (PRISM) Study

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.

Recruiting

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60130, United States

Location status: Recruiting

Location contact

Melissa Crane

CONTACT

[email protected]

312-942-1282

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Recruitment rate

    Time frame: Baseline

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

  2. Acceptability of the Intervention

    Time frame: 3 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).

Secondary outcomes

  1. Medication adherence duration questions

    Time frame: From consent to reported discontinuation, up to 22 months

    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.

  2. Reasons for Discontinuation questions

    Time frame: Baseline

    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.

Other outcomes

  1. Recruitment efficiency

    Time frame: Baseline

    Recruitment efficiency will be defined as the days between the participant's last AOM dose and the date of randomization into the trial.

  2. Retention to the study

    Time frame: 6 months post-randomization

    Retention to the study will be defined as an observed weight assessed during the 6-month assessment period.

  3. Intervention adherence

    Time frame: Randomization to 6 months

    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).

  4. Percent weight change

    Time frame: 3 and 6 months post-randomization

    Weight data for outcome assessments (0, 3, and 6 months) will be collected remotely.

  5. Adherence to dietary self-monitoring

    Time frame: Randomization to 6 months

    Active treatment arm only: portion of days adherent to self-monitoring recommendations

  6. Physical activity

    Time frame: Randomization to 6 months

    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.

  7. Self-weighing frequency

    Time frame: Randomization to 6 months

    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.

  8. Intervention staff time

    Time frame: Randomization to 6 months

    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.

  9. Trial protocol staff time

    Time frame: Baseline to 6 months

    Staff will track their time conducting recruitment efforts, consent visits, and conducting and scheduling assessment appointments.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa M Crane, PhD

CONTACT

[email protected]

312-942-1282

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Acronym: PRISM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 17, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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