Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06596265

Conditions

Anxiety

Wellness, Psychological

Overweight or Obesity

Hypertension

Prehypertension

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

Fit2Lead Group 1-2

Study Details

Brief 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.

Conditions

Anxiety

Wellness, Psychological

Overweight or Obesity

Hypertension

Prehypertension

Study ID

NCT06596265

Start date

Feb 17, 2016

Status verified date

Sep, 2025

Completion date

Jun 17, 2028

Anticipated

Primary completion date

Jun 17, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Fit2 Lead Cohort 1-2

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.

Interventions

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 measure

  • 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 ]
  • Change in Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: Baseline, 12-72 months ]
  • Change in Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: Baseline, 12-72 months ]
  • Change in the Progressive Aerobic Cardiovascular Endurance Run (PACER) score [ Time Frame: Baseline, 12-72 months ]
  • Change in Brief Sense of Community Scale (BSCS) [ Time Frame: Baseline, 12-72 months ]
  • Change in Sociopolitical Control Scale for Youth (SCPS-Y; Leadership subscale) [ Time Frame: Baseline, 12-72 months ]
  • Change in Self-efficacy for teen conflict (SE-TCS) [ Time Frame: Baseline, 12-72 months ]
  • Change in Casey Life Skills Assessment [ Time Frame: Baseline, 12-72 months ]
  • Change in Perceived Stress Scale (PSS) [ Time Frame: Baseline, 12-72 months ]

Central Contacts and Locations

Central contacts

Emily D'Agostino

Emily.M.D'Agostino@duke.edu

Locations

Miami-Dade County Parks, Recreation and Open Spaces Department

Recruiting

Miami, Florida, United States, 33128

More Information

Sponsor

Duke University

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Keywords

  • Youth
  • Adolescent
  • Afterschool
  • Parks and Recreation
  • Mental Health
  • Physical Helath
  • Resilience
  • Violence Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-09-10.