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:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT04560335
Eligibility Criteria:
Inclusion Criteria:
* chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depressive disorder with psychosis;
* age 18 and over;
* BMI \>= 30.0 (obese); and
* ownership of a phone running Android OS or iOS (iPhone).
Exclusion Criteria:
* chart diagnosis of dementia;
* history of bariatric surgery;
* pregnant and nursing mothers;
* patient has a conservator/legally authorized representative who makes their medical decisions;
* psychiatric hospitalization during the month prior to enrollment.
Additionally, we will follow the American College of Sports Medicine recommendations for health screening and risk stratification in preparation for starting a moderate intensity exercise program to ensure that participants enrolled are capable of safely engaging in the app's recommendations regarding physical activity. Specifically, all potential participants will be given the Physical Activity Readiness Questionnaire (PAR-Q), a screening tool often used in weight management trials. If they endorse symptoms or major signs suggestive of cardiopulmonary disease (i.e., angina, anginal equivalent, dyspnea, syncope, orthopnea, edema, palpitations or claudication), which is a score \>=1 on the PAR-Q, they will need clearance from a VA physician before enrolling.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04560335
Study Brief:
Protocol Section:
NCT04560335