Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT07288294
Eligibility Criteria:
Inclusion Criteria:
1. Obesity (body mass index ≥30 kg/m2 or ≥27 kg/m2 with obesity-related comorbidity or self-identified Asian race)
2. For run-in: prescribed liraglutide, semaglutide, or tirzepatide or newer medication approved by the FDA for long-term use for obesity treatment 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.
3. For randomization: discontinue their prescribed anti-obesity medication.
4. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07288294
Study Brief:
Protocol Section:
NCT07288294