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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT07282418
Eligibility Criteria:
Eligibility criteria for BEAR main cohort enrollment (N=120):
* Age 18 years or older
* Fluent in English
* Lives within 10 miles of the study site
* Not planning to move outside the study region in the next 6 months
* Has a working Android or iOS mobile device they are willing to use for EMA surveys and communication with the study team
* No apparent cognitive deficits that would suggest a lack of capacity to consent or complete study procedures
* No uncontrolled serious mental illness, marked by an inpatient hospitalization, increase or change in antipsychotic or mood stabilizing medication, or suicidal intent in the past 6 months.
Eligibility for selection into the RCT component (n=60):
* At least 75% adherence to EMA surveys during the initial assessment
* Complete baseline data within the observational cohort component
* Participant endorses engagement in recreation less than 4 times per week based on EMA surveys
* LE8 score \<70, reflecting low to moderate cardiometabolic health.
* No serious substance abuse problem based on an ASSIST score of ≥27 for any substance other than tobacco or cannabis
* Willing and able to try recreational activities for the next 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07282418
Study Brief:
Protocol Section:
NCT07282418