NCT06596265 · Duke University
Community Park-Based Programs for Health Promotion: The Fit2Lead Prospective Cohort Study
(F2L)
What this study is about
The Fit2Lead forward-looking group of participants 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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
Time frame: Baseline, 12-72 months
The Kidscreen-27 score range is 27-135. A higher score indicates more positive well-being.
Change in Generalized Anxiety Disorder 7-item (GAD-7)
Time frame: Baseline, 12-72 months
The GAD-7 has a score range 0-21. Higher score indicates higher anxiety levels.
Change in Patient Health Questionnaire-8 (PHQ-8)
Time frame: Baseline, 12-72 months
The PHQ-8 has a score range 0-24. Higher score indicates higher depression levels.
Change in the Progressive Aerobic Cardiovascular Endurance Run (PACER) score
Time frame: Baseline, 12-72 months
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.
Change in Brief Sense of Community Scale (BSCS)
Time frame: Baseline, 12-72 months
The Brief Sense of Community Scale (BSCS) has a total score range of 0-32. Higher score indicates more positive sense of community.
Change in Sociopolitical Control Scale for Youth (SCPS-Y; Leadership subscale)
Time frame: Baseline, 12-72 months
The SCPS-Y has a range 1-6. Higher scores indicate higher policy control, leadership competence, sense of community, ethnic identity, and social support.
Change in Self-efficacy for teen conflict (SE-TCS)
Time frame: Baseline, 12-72 months
Possible range for the SE-TCS is 5 to 25' with higher scores indicating more confidence
Change in Casey Life Skills Assessment
Time frame: Baseline, 12-72 months
Casey Life Skills Assessment (CLSA) scores are on a scale of 1-5, with 5 representing the highest level of strength
Change in Perceived Stress Scale (PSS)
Time frame: Baseline, 12-72 months
The Perceived Stress Scale (PSS) has a score range of 0 to 40, with higher scores indicating greater perceived stress.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Miami, Florida
Collaborators
Miami-Dade County Parks and Recreation, The Children's Trust, Miami FL
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 10, 2025 · Source of record for eligibility and locations