Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study

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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.