Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-13 @ 7:50 AM
Study NCT ID:
NCT06595251
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D058246', 'term': 'Prehypertension'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-05-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Weight', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in Height', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in Waist-to-Hip Circumference', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in Pulse', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in Blood Pressure', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in PACER score', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in sit-and-reach test', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in number of push-ups', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in number of sit-ups', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in Kidscreen-27', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in GAD-7', 'timeFrame': 'Baseline, 12-72 MONTHS'}, {'measure': 'Change in PHQ-8', 'timeFrame': 'Baseline, 12-72 MONTHS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Youth', 'Afterschool', 'Parks and Recreation', 'Mental Health', 'Physical Health', 'Physical Activity', 'Exercise'], 'conditions': ['Overweight', 'Obesity', 'Hypertension', 'Prehypertension', 'Anxiety', 'Well-being', 'Depression', 'Low Physical Fitness', 'Psychological']}, 'referencesModule': {'references': [{'pmid': '29175865', 'type': 'BACKGROUND', 'citation': "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': '33524953', 'type': 'BACKGROUND', 'citation': "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': '29599055', 'type': 'BACKGROUND', 'citation': "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': '28689339', 'type': 'BACKGROUND', 'citation': "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': '29703522', 'type': 'BACKGROUND', 'citation': "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': '29705630', 'type': 'BACKGROUND', 'citation': "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': '33596444', 'type': 'BACKGROUND', 'citation': "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': '32880096', 'type': 'BACKGROUND', 'citation': "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': '29748417', 'type': 'BACKGROUND', 'citation': "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': '31132717', 'type': 'BACKGROUND', 'citation': "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."}, {'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants enrolled in the Miami-Dade Fit2Play study will be included in this secondary analysis\n\nExclusion Criteria:\n\n* Anyone not enrolled in the Miami-Dade Fit2Play study will be excluded from this secondary analysis'}, 'identificationModule': {'nctId': 'NCT06595251', 'acronym': 'F2P', 'briefTitle': 'Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'Pro00105669'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fit2Play Program', 'interventionNames': ['Other: Fit2Play curriculum']}], 'interventions': [{'name': 'Fit2Play curriculum', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Fit2Play Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33128', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Miami-Dade County Parks, Recreation and Open Spaces Department', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': "Emily M D'Agostino, DPH, MS, MEd, MA", 'role': 'CONTACT', 'email': 'emily.m.dagostino@duke.edu', 'phone': '+1 919 668 8540'}], 'overallOfficials': [{'name': "Emily D'Agostino, DPH, MS, MEd, MA", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Miami-Dade County Parks and Recreation', 'class': 'OTHER'}, {'name': "The Children's Trust, Miami FL", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}