Community Park-Based Programs for Health Promotion: The Fit2Lead Prospective Cohort Study (NCT06596265) | Clinical Trial Compass
RecruitingNot Applicable
Community Park-Based Programs for Health Promotion: The Fit2Lead Prospective Cohort Study
United States1,000 participantsStarted 2016-02-17
Plain-language summary
The Fit2Lead prospective cohort study examines the effects of a park-based youth mental health and resilience afterschool program on youth participant mental health, resilience, physical fitness, and violence prevention outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Lead prospective cohort study run by Miami-Dade County Parks and Recreation.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All participants enrolled in the Miami-Dade Fit2Lead study will be included in this secondary analysis
* Aged 12-17 years, residing in Miami-Dade County
Exclusion Criteria:
* Anyone not enrolled in the Miami-Dade Fit2Lead study will be excluded from this secondary analysis
* Aged \<12 or \>17 years, not residing in Miami-Dade County, cannot read and speak in English
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Weight
Timeframe: Baseline, 12-72 months
2
Change in Blood Pressure
Timeframe: Baseline, 12-72 months
3
Change in number of push-ups
Timeframe: Baseline, 12-72 months
4
Change in number of sit-ups
Timeframe: Baseline, 12-72 months
5
Change in Career and Education Planning survey
Timeframe: Baseline, 12-72 months
6
Change in College and Career Readiness survey
Timeframe: Baseline, 12-72 months
7
Change in Kidscreen-27
Timeframe: Baseline, 12-72 months
8
Change in Generalized Anxiety Disorder 7-item (GAD-7)