Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06595251

Conditions

Overweight

Obesity

Hypertension

Prehypertension

Anxiety

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Accepted

Interventions

Fit2Play curriculum

Study Details

Brief summary:

The Fit2Play prospective cohort study examines the effects of a park-based youth physical activity afterschool program on youth participant fitness and mental health outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Play prospective cohort study run by Miami-Dade County Parks and Recreation.

Conditions

Overweight

Obesity

Hypertension

Prehypertension

Anxiety

Study ID

NCT06595251

Start date

May 7, 2020

Status verified date

Sep, 2025

Completion date

May 17, 2027

Anticipated

Primary completion date

May 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 14

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All participants enrolled in the Miami-Dade Fit2Play study will be included in this secondary analysis

Exclusion Criteria:

  • Anyone not enrolled in the Miami-Dade Fit2Play study will be excluded from this secondary analysis

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Fit2Play Program

Interventions

Fit2Play curriculum

Fit2Play is a daily after-school park-based program (Monday-Friday, 2 PM-6 PM) that comprises (1) 60 minutes of physical activity that incorporates multiple sports (soccer, kickball, flag football) and activities from Sports, Play and Active Recreation for Kids (SPARK), a play- and evidenced-based, outcome-oriented, structured, active recreation program for children with a focus on developing and improving motor skills, movement knowledge, social and personal skills; and (2) 20-30 minutes of nutrition education lessons 1-2 times per week that incorporate EmpowerMe4Life, a health and wellness curriculum aligned to the National Health Education Standards for fifth grade and grounded in the American Heart Association's scientific recommendations in promoting heart-healthy lifestyles. Miami-Dade Parks and Recreation is the sponsor of the Fit2Play prospective cohort study. Duke is conducting a secondary data analysis on data collected as part of the Fit2Play study.

Primary outcome measure

  • Change in Weight [ Time Frame: Baseline, 12-72 MONTHS ]
  • Change in Height [ Time Frame: Baseline, 12-72 MONTHS ]
  • Change in Waist-to-Hip Circumference [ Time Frame: Baseline, 12-72 MONTHS ]
  • Change in Pulse [ Time Frame: Baseline, 12-72 MONTHS ]
  • Change in Blood Pressure [ Time Frame: Baseline, 12-72 MONTHS ]
  • Change in PACER score [ Time Frame: Baseline, 12-72 MONTHS ]
  • Change in sit-and-reach test [ 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 Kidscreen-27 [ Time Frame: Baseline, 12-72 MONTHS ]
  • Change in GAD-7 [ Time Frame: Baseline, 12-72 MONTHS ]
  • Change in PHQ-8 [ Time Frame: Baseline, 12-72 MONTHS ]

Central Contacts and Locations

Central contacts

Emily M D'Agostino, DPH, MS, MEd, MA

+1 919 668 8540emily.m.dagostino@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 4, 2025

Last verified

Sep, 2025

Keywords

  • Youth
  • Afterschool
  • Parks and Recreation
  • Mental Health
  • Physical Health
  • Physical Activity
  • Exercise

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 2025-09-04.