An observational study in Anxiety, Wellness, Psychological and Overweight or Obesity, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Duke University · Observational
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.
The Fit2Lead prospective cohort study examines the effects of a park-based youth mental health and resilience afterschool program on youth physical and mental health and resilience, communication, and problem-solving skills training for underserved youth aged 12 to 17 years through an interdisciplinary collaboration among Miami-Dade Department of Parks, Recreation and Open Spaces (MDPROS) Miami-Dade County (MDC) Juvenile Services Department, MDC Public Schools, MDC Police Department, University of Miami, Florida International University, and other community-based partners.
Fit2Lead consists of 2 phases initiated simultaneously in 2015. For youth aged 12 to 14 years, Fit2Lead is offered after school Monday through Friday from 3:00 pm to 7:00 pm at 12 MDC parks for participants in under resourced neighborhoods and based on area-level youth crime and neighborhood poverty. Fit2Lead runs September through June at no charge, and provides daily academic support, sports and recreation, meditation, stress resilience, and life skills-focused workshops. Each park serves anywhere from 2 to 9 feeder schools within these neighborhoods (a target population of 34 000 youth residents aged 12-17 years), and transportation from schools to parks is provided at no cost within a 3-mile radius of a program park. Fit2Lead participants can also enroll in the MDPROS youth summer camp at no charge.
Phase II of Fit2Lead is for youth aged 15 to 17 years and entails a year-round paid internship and 3-hour weekly enrichment, resilience, and life skills workshops. Daily entry-level part-time interns receive $9 per hour (approximately 500 total paid hours per year; total salary approximately $4000 per participant, per year). Work assignments support MDPROS operations and recreation staff. Interns rotate every 8 weeks for exposure to different job opportunities, supervisors, and mentors. Phase 1 participants who reach age 15 years and are awaiting an internship placement can remain in phase 1 until a position opens or can be transferred to another internship program within the MDPROS.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Fit2Lead is offered in areas composed of 48% male youths, 60% Hispanic persons, 29% non-Hispanic Black persons, 33% single-parent households, and 33% of residents living below the federal poverty threshold as defined by the American Community Survey. Thirty-three percent of families are single-parent households, and 33% of residents are living in poverty in zip codes where Fit2Lead is offered.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Fit2Lead runs September through June at no charge, and provides daily academic support, sports and recreation, meditation, stress resilience, and life skills-focused workshops. Participants who reach age 15 years and are awaiting an internship placement can remain in phase 1 until a position opens or can be transferred to another internship program within the MDPROS.
Behavioral: Fit2Lead Group 1-2
Each park serves anywhere from 2 to 9 feeder schools within these neighborhoods (a target population of 34 000 youth residents aged 12-17 years), and transportation from schools to parks is provided at no cost within a 3-mile radius of a program park. Fit2Lead participants can also enroll in the MDPROS youth summer camp at no charge. Work assignments support MDPROS operations and recreation staff. Interns in Phase II rotate every 8 weeks for exposure to different job opportunities, supervisors, and mentors. Duke is conducting a secondary data analysis on data collected as part of the Fit2Lead study.
Change in Weight
Time frame: Baseline, 12-72 months
Change in Blood Pressure
Time frame: Baseline, 12-72 months
Change in number of push-ups
Time frame: Baseline, 12-72 months
Change in number of sit-ups
Time frame: Baseline, 12-72 months
Change in Career and Education Planning survey
Time frame: Baseline, 12-72 months
Change in College and Career Readiness survey
Time frame: Baseline, 12-72 months
Change in Kidscreen-27
The Kidscreen-27 score range is 27-135. A higher score indicates more positive well-being.
Time frame: Baseline, 12-72 months
Change in Generalized Anxiety Disorder 7-item (GAD-7)
The GAD-7 has a score range 0-21. Higher score indicates higher anxiety levels.
Time frame: Baseline, 12-72 months
Change in Patient Health Questionnaire-8 (PHQ-8)
The PHQ-8 has a score range 0-24. Higher score indicates higher depression levels.
Time frame: Baseline, 12-72 months
Change in the Progressive Aerobic Cardiovascular Endurance Run (PACER) score
Among boys, for ages 10-17, the healthy fitness range is 23-61 laps for age 10, 23-72 laps for age 11, 32-72 laps for age 12, and 41-83 laps for ages 13 and up; Among girls, for ages 10-17, the healthy fitness range is 7-41 laps for age 10, 15-41 laps for ages 11 and 12, and 23-51 laps for ages 13 and up. A higher score indicates greater aerobic capacity.
Time frame: Baseline, 12-72 months
Change in Brief Sense of Community Scale (BSCS)
The Brief Sense of Community Scale (BSCS) has a total score range of 0-32. Higher score indicates more positive sense of community.
Time frame: Baseline, 12-72 months
Change in Sociopolitical Control Scale for Youth (SCPS-Y; Leadership subscale)
The SCPS-Y has a range 1-6. Higher scores indicate higher policy control, leadership competence, sense of community, ethnic identity, and social support.
Time frame: Baseline, 12-72 months
Change in Self-efficacy for teen conflict (SE-TCS)
Possible range for the SE-TCS is 5 to 25' with higher scores indicating more confidence
Time frame: Baseline, 12-72 months
Change in Casey Life Skills Assessment
Casey Life Skills Assessment (CLSA) scores are on a scale of 1-5, with 5 representing the highest level of strength
Time frame: Baseline, 12-72 months
Change in Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) has a score range of 0 to 40, with higher scores indicating greater perceived stress.
Time frame: Baseline, 12-72 months
Plan to share: No
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