OverweightF2PNCT06595251
Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study
An observational study of Overweight and Obesity, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Hypertension
- What is being tested?
- Fit2Play curriculum
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2020to 17 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- All participants enrolled in the Miami-Dade Fit2Play study will be included in this secondary analysis
Who cannot join
- Anyone not enrolled in the Miami-Dade Fit2Play study will be excluded from this secondary analysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Miami-Dade County Parks, Recreation and Open Spaces Department
Miami, Florida, 33128
About this study
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.
Read the detailed description
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.
- Conditions
- Overweight, Obesity, Hypertension, Prehypertension, Anxiety, Well-being
- Being tested
- Fit2Play curriculum
- Keywords
- Youth, Afterschool, Parks and Recreation, Mental Health, Physical Health, Physical Activity, Exercise
- Medical subject headings
- Overweight, Obesity, Hypertension, Prehypertension, Anxiety Disorders, Depression, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit2Play curriculumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fit2Play Program | Not described Receives: Other: Fit2Play curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Measured: Baseline, 12-72 MONTHS
Change in Height
Measured: Baseline, 12-72 MONTHS
Change in Waist-to-Hip Circumference
Measured: Baseline, 12-72 MONTHS
Change in Pulse
Measured: Baseline, 12-72 MONTHS
Change in Blood Pressure
Measured: Baseline, 12-72 MONTHS
Change in PACER score
Measured: Baseline, 12-72 MONTHS
Change in sit-and-reach test
Measured: Baseline, 12-72 MONTHS
Change in number of push-ups
Measured: Baseline, 12-72 MONTHS
Change in number of sit-ups
Measured: Baseline, 12-72 MONTHS
Change in Kidscreen-27
Measured: Baseline, 12-72 MONTHS
Change in GAD-7
Measured: Baseline, 12-72 MONTHS
Change in PHQ-8
Measured: Baseline, 12-72 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 May 2020
- Primary completion17 May 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Miami-Dade County Parks and Recreation, The Children's Trust, Miami FL
- Responsible party
- Sponsor
- Investigators
- Emily D'Agostino, DPH, MS, MEd, MA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595251
- Sponsor's protocol ID
- Pro00105669
- Acronym
- F2P
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29175865Booth 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.
PubMed 33524953D'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.
PubMed 29599055Messiah 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.
PubMed 28689339Messiah 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.
PubMed 29703522D'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.
PubMed 29705630Zewdie 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.
PubMed 33596444D'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.
PubMed 32880096D'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.
PubMed 29748417D'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.
PubMed 31132717Patel 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06595251
- Acronym / sponsor ID
- F2P / Pro00105669
- Conditions
- Overweight, Obesity, Hypertension, Prehypertension, Anxiety, Well-being
- Keywords
- Youth, Afterschool, Parks and Recreation, Mental Health, Physical Health, Physical Activity, Exercise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Miami-Dade County Parks and Recreation, The Children's Trust, Miami FL
- Study start
- 7 May 2020 (actual)
- Primary completion
- 17 May 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fit2Play Program | – | Other: Fit2Play curriculum |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All participants enrolled in the Miami-Dade Fit2Play study will be included in this secondary analysis
Key exclusion criteria (1 listed)
- Anyone not enrolled in the Miami-Dade Fit2Play study will be excluded from this secondary analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fit2Play curriculumFit2Play 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. | Other | Fit2Play Program |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Background: PubMed 29175865D'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.
- Background: PubMed 33524953Booth 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.
- Background: PubMed 29599055D'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.
- Background: PubMed 28689339Messiah 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.
- Background: PubMed 29703522Messiah 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.
- Background: PubMed 29705630D'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.
- Background: PubMed 33596444Zewdie 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.
- Background: PubMed 32880096D'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.
- Background: PubMed 29748417D'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.
- Background: PubMed 31132717D'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.
- BackgroundPatel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily D'Agostino, DPH, MS, MEd, MA principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily M D'Agostino, DPH, MS, MEd, MA (+1 919 668 8540, emily.m.dagostino@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: Baseline, 12-72 MONTHS). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06595251, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.