NCT06596265

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Feb 2016Jun 2028

Study Start

First participant enrolled

February 17, 2016

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2028

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

12.3 years

First QC Date

September 11, 2024

Last Update Submit

September 3, 2025

Conditions

Keywords

YouthAdolescentAfterschoolParks and RecreationMental HealthPhysical HelathResilienceViolence Prevention

Outcome Measures

Primary Outcomes (15)

  • Change in Weight

    Baseline, 12-72 months

  • Change in Blood Pressure

    Baseline, 12-72 months

  • Change in number of push-ups

    Baseline, 12-72 months

  • Change in number of sit-ups

    Baseline, 12-72 months

  • Change in Career and Education Planning survey

    Baseline, 12-72 months

  • Change in College and Career Readiness survey

    Baseline, 12-72 months

  • Change in Kidscreen-27

    The Kidscreen-27 score range is 27-135. A higher score indicates more positive well-being.

    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.

    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.

    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.

    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.

    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.

    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

    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

    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.

    Baseline, 12-72 months

Study Arms (1)

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.

Behavioral: Fit2Lead Group 1-2

Interventions

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.

Fit2 Lead Cohort 1-2

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami-Dade County Parks, Recreation and Open Spaces Department

Miami, Florida, 33128, United States

RECRUITING

Related Publications (5)

  • D'Agostino EM, Frazier SL, Hansen E, Patel HH, Ahmed Z, Okeke D, Nardi MI, Messiah SE. Two-Year Changes in Neighborhood Juvenile Arrests After Implementation of a Park-Based Afterschool Mental Health Promotion Program in Miami-Dade County, Florida, 2015-2017. Am J Public Health. 2019 Jun;109(S3):S214-S220. doi: 10.2105/AJPH.2019.305050.

    PMID: 31241997BACKGROUND
  • D'Agostino E, Frazier SL, Hansen E, Nardi MI, Messiah SE. Association of a Park-Based Violence Prevention and Mental Health Promotion After-School Program With Youth Arrest Rates. JAMA Netw Open. 2020 Jan 3;3(1):e1919996. doi: 10.1001/jamanetworkopen.2019.19996.

    PMID: 31995210BACKGROUND
  • Goodman AC, Ouellette RR, D'Agostino EM, Hansen E, Lee T, Frazier SL. Promoting healthy trajectories for urban middle school youth through county-funded, parks-based after-school programming. J Community Psychol. 2021 Sep;49(7):2795-2817. doi: 10.1002/jcop.22587. Epub 2021 Apr 29.

    PMID: 33914915BACKGROUND
  • Frazier SL, Chou T, Ouellette RR, Helseth SA, Kashem ER, Cromer KD. Workforce Support for Urban After-School Programs: Turning Obstacles into Opportunities. Am J Community Psychol. 2019 Jun;63(3-4):430-443. doi: 10.1002/ajcp.12328. Epub 2019 Apr 19.

    PMID: 31002394BACKGROUND
  • Cromer KD, D'Agostino EM, Hansen E, Alfonso C, Frazier SL. After-school poly-strengths programming for urban teens at high risk for violence exposure. Transl Behav Med. 2019 May 16;9(3):541-548. doi: 10.1093/tbm/ibz013.

    PMID: 31094433BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPsychological Well-BeingOverweightObesityHypertensionPrehypertension

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Emily D'Agostino

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily D'Agostino

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

February 17, 2016

Primary Completion (Estimated)

June 17, 2028

Study Completion (Estimated)

June 17, 2028

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations