Obesity
Conditions
Brief summary
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
BEHAVIORALPRISM 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, asynchronous online check-ins weekly for 12 weeks, and bi-weekly for 12 weeks.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This project is a randomized feasibility study with a run-in period
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Baseline | The recruitment rate will be defined as the number of participants randomized into the clinical trial per month. |
| Acceptability of the Intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence duration questions | 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. |
| Reasons for Discontinuation questions | 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. |
Countries
United States
Contacts
CONTACTMelissa M Crane, PhD
Outcome results
None listed