An observational study in Overweight, Obesity and Hypertension, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 6 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Duke University · Observational
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.
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. The Fit2Play program was designed by a team of MDPROS professionals and UM faculty. It 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. Fit2Play programming is implemented by park coaches, who are hired with health and wellness training and/or education-specific background(s) with at least a high school degree. Participants are divided into younger (6-9 years) and older (10-14 years) age groups regardless of weight status, and coaches choose daily age-appropriate SPARK and other physical activities for each group. With an oversight from a registered dietician, similarly, the UM-MDPROS team has expanded the EmpowerMe4Life curriculum to include younger (6-9 years) and older (10-14 years) age group modules.
The research team includes a large community organization (Miami-Dade County Parks and Recreation Department). All consented Fit2Play participants (400-800 per year) complete a baseline (August/September) and post-test (May/June) assessment during each school year of participation that include demographic, mental health symptom questionnaires, satisfaction surveys, and on-site physical fitness and biometric measurements. Data collection is performed by a core MDPROS measurement team who are trained and certified by University of Miami School of Medicine faculty. In addition, MDPROS bachelor/master's level recreation directors oversee on-site measurement procedures and collection of all predata and postdata to ensure measurement fidelity. Data are then uploaded to a shared (parks and university) database via a data management team.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: 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.
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
Plan to share: No
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