PRImary Care Strategies for Weight Management (PRISM) Study
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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+
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PRISM Program
BehavioralThis 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.
Treatment groups
214 Participants
are divided into 2 treatment groupsGroup A: PRISM ProgramExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate
The recruitment rate will be defined as the number of participants randomized into the clinical trial per month.
Time frame
Baseline2
Acceptability of the Intervention
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).
Time frame
3 and 6 months post randomizationSecondary outcomes
1
Medication adherence duration questions
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.
Time frame
From consent to reported discontinuation, up to 22 months2
Reasons for Discontinuation questions
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.
Time frame
BaselineOther outcomes
1
Recruitment efficiency
Recruitment efficiency will be defined as the days between the participant's last AOM dose and the date of randomization into the trial.
Time frame
Baseline2
Retention to the study
Retention to the study will be defined as an observed weight assessed during the 6-month assessment period.
Time frame
6 months post-randomization3
Intervention adherence
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).
Time frame
Randomization to 6 months4
Percent weight change
Weight data for outcome assessments (0, 3, and 6 months) will be collected remotely.
Time frame
3 and 6 months post-randomizationSponsors and contacts
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Source ClinicalTrials.gov