NCT06595251

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started May 2020

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 Progress85%
May 2020May 2027

Study Start

First participant enrolled

May 7, 2020

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2027

Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

7 years

First QC Date

September 10, 2024

Last Update Submit

September 3, 2025

Conditions

Keywords

YouthAfterschoolParks and RecreationMental HealthPhysical HealthPhysical ActivityExercise

Outcome Measures

Primary Outcomes (12)

  • Change in Weight

    Baseline, 12-72 MONTHS

  • Change in Height

    Baseline, 12-72 MONTHS

  • Change in Waist-to-Hip Circumference

    Baseline, 12-72 MONTHS

  • Change in Pulse

    Baseline, 12-72 MONTHS

  • Change in Blood Pressure

    Baseline, 12-72 MONTHS

  • Change in PACER score

    Baseline, 12-72 MONTHS

  • Change in sit-and-reach test

    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 Kidscreen-27

    Baseline, 12-72 MONTHS

  • Change in GAD-7

    Baseline, 12-72 MONTHS

  • Change in PHQ-8

    Baseline, 12-72 MONTHS

Study Arms (1)

Fit2Play Program

Other: Fit2Play curriculum

Interventions

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.

Fit2Play Program

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Fit2Play aims to enroll youth ages 6-14 years who are majority Hispanic and non-Hispanic black, 50% male; approximately 60% of the population will be normal weight, 15% with overweight, and 25% with obesity.

You may qualify if:

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

You may not qualify if:

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

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 (11)

  • D'Agostino EM, Patel HH, Hansen E, Mathew MS, Nardi M, Messiah SE. Longitudinal analysis of cardiovascular disease risk profile in neighbourhood poverty subgroups: 5-year results from an afterschool fitness programme in the USA. J Epidemiol Community Health. 2018 Mar;72(3):193-201. doi: 10.1136/jech-2017-209333. Epub 2017 Nov 24.

    PMID: 29175865BACKGROUND
  • Booth JV, Messiah SE, Hansen E, Nardi MI, Hawver E, Patel HH, Kling H, Okeke D, D'Agostino EM. Objective Measurement of Physical Activity Attributed to a Park-Based Afterschool Program. J Phys Act Health. 2021 Mar 1;18(3):329-336. doi: 10.1123/jpah.2020-0162. Epub 2021 Jan 31.

    PMID: 33524953BACKGROUND
  • D'Agostino EM, Patel HH, Hansen E, Mathew MS, Nardi MI, Messiah SE. Effect of participation in a park-based afterschool program on cardiovascular disease risk among severely obese youth. Public Health. 2018 Jun;159:137-143. doi: 10.1016/j.puhe.2018.02.025. Epub 2018 Mar 27.

    PMID: 29599055BACKGROUND
  • Messiah SE, D'Agostino EM, Hansen E, Mathew MS, Okeke D, Nardi M, Kardys J, Arheart KL. Longitudinal Impact of a Park-Based Afterschool Healthy Weight Program on Modifiable Cardiovascular Disease Risk Factors in Youth. J Community Health. 2018 Feb;43(1):103-116. doi: 10.1007/s10900-017-0393-9.

    PMID: 28689339BACKGROUND
  • Messiah SE, D'Agostino EM, Patel HH, Hansen E, Mathew MS, Arheart KL. Sex differences in fitness outcomes among minority youth after participation in a park-based after-school program. Ann Epidemiol. 2018 Jul;28(7):432-439. doi: 10.1016/j.annepidem.2018.03.020. Epub 2018 Apr 12.

    PMID: 29703522BACKGROUND
  • D'Agostino EM, Patel HH, Ahmed Z, Hansen E, Sunil Mathew M, Nardi MI, Messiah SE. Impact of change in neighborhood racial/ethnic segregation on cardiovascular health in minority youth attending a park-based afterschool program. Soc Sci Med. 2018 May;205:116-129. doi: 10.1016/j.socscimed.2018.03.038. Epub 2018 Mar 27.

    PMID: 29705630BACKGROUND
  • Zewdie H, Zhao AY, Patel HH, Hansen E, Messiah SE, Armstrong SC, Skinner AC, Neshteruk CD, Hipp JA, D'Agostino EM. The association between neighborhood quality, youth physical fitness, and modifiable cardiovascular disease risk factors. Ann Epidemiol. 2021 May;57:30-39. doi: 10.1016/j.annepidem.2021.02.004. Epub 2021 Feb 14.

    PMID: 33596444BACKGROUND
  • D'Agostino EM, Patel HH, Hansen E, Mathew MS, Messiah SE. Longitudinal Effects of Transportation Vulnerability on the Association Between Racial/Ethnic Segregation and Youth Cardiovascular Health. J Racial Ethn Health Disparities. 2021 Jun;8(3):618-629. doi: 10.1007/s40615-020-00821-8. Epub 2020 Sep 2.

    PMID: 32880096BACKGROUND
  • D'Agostino EM, Patel HH, Ahmed Z, Hansen E, Mathew MS, Nardi MI, Messiah SE. Natural experiment examining the longitudinal association between change in residential segregation and youth cardiovascular health across race/ethnicity and gender in the USA. J Epidemiol Community Health. 2018 Jul;72(7):595-604. doi: 10.1136/jech-2018-210592. Epub 2018 May 10.

    PMID: 29748417BACKGROUND
  • D'Agostino EM, Patel HH, Hansen E, Mathew MS, Nardi MI, Messiah SE. Does transportation vulnerability explain the relationship between changes in exposure to segregation and youth cardiovascular health? Health Place. 2019 May;57:265-276. doi: 10.1016/j.healthplace.2019.04.002. Epub 2019 May 24.

    PMID: 31132717BACKGROUND
  • Patel HH, Messiah SE, Hansen E, D'Agostino EM. The relationship between transportation vulnerability, school attendance, and free transportation to an afterschool program for youth. Transportation. 2021 Oct;48(5):2315-33.

    BACKGROUND

MeSH Terms

Conditions

OverweightObesityHypertensionPrehypertensionAnxiety DisordersDepressionPsychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesMental DisordersBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

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

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

May 7, 2020

Primary Completion (Estimated)

May 17, 2027

Study Completion (Estimated)

May 17, 2027

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations