[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06596265":3,"trial-entities:NCT06596265":138,"trial-summary:NCT06596265":142},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":33,"primary_purpose":34,"phases":35,"enrollment_info":36,"interventions":39,"primary_outcomes":46,"secondary_outcomes":87,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":91,"eligibility_criteria":92,"std_ages":100,"locations":102,"central_contacts":112,"overall_officials":117,"references":120,"see_also_links":137},"NCT06596265","Pro00105669_2","Community Park-Based Programs for Health Promotion: The Fit2Lead Prospective Cohort Study","RECRUITING","2028-06-17","2025-09","2025-09-10","2016-02-17","Duke University","OTHER",false,"The Fit2Lead prospective cohort study examines the effects of a park-based youth mental health and resilience afterschool program on youth participant mental health, resilience, physical fitness, and violence prevention outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Lead prospective cohort study run by Miami-Dade County Parks and Recreation.","The Fit2Lead prospective cohort study examines the effects of a park-based youth mental health and resilience afterschool program on youth physical and mental health and resilience, communication, and problem-solving skills training for underserved youth aged 12 to 17 years through an interdisciplinary collaboration among Miami-Dade Department of Parks, Recreation and Open Spaces (MDPROS) Miami-Dade County (MDC) Juvenile Services Department, MDC Public Schools, MDC Police Department, University of Miami, Florida International University, and other community-based partners.\n\nFit2Lead consists of 2 phases initiated simultaneously in 2015. For youth aged 12 to 14 years, Fit2Lead is offered after school Monday through Friday from 3:00 pm to 7:00 pm at 12 MDC parks for participants in under resourced neighborhoods and based on area-level youth crime and neighborhood poverty. Fit2Lead runs September through June at no charge, and provides daily academic support, sports and recreation, meditation, stress resilience, and life skills-focused workshops. Each park serves anywhere from 2 to 9 feeder schools within these neighborhoods (a target population of 34 000 youth residents aged 12-17 years), and transportation from schools to parks is provided at no cost within a 3-mile radius of a program park. Fit2Lead participants can also enroll in the MDPROS youth summer camp at no charge.\n\nPhase II of Fit2Lead is for youth aged 15 to 17 years and entails a year-round paid internship and 3-hour weekly enrichment, resilience, and life skills workshops. Daily entry-level part-time interns receive $9 per hour (approximately 500 total paid hours per year; total salary approximately $4000 per participant, per year). Work assignments support MDPROS operations and recreation staff. Interns rotate every 8 weeks for exposure to different job opportunities, supervisors, and mentors. Phase 1 participants who reach age 15 years and are awaiting an internship placement can remain in phase 1 until a position opens or can be transferred to another internship program within the MDPROS.",[18,19,20,21,22,23],"Anxiety","Wellness, Psychological","Overweight or Obesity","Hypertension","Prehypertension","Low Physical Fitness",[25,26,27,28,29,30,31,32],"Youth","Adolescent","Afterschool","Parks and Recreation","Mental Health","Physical Helath","Resilience","Violence Prevention","OBSERVATIONAL",null,[],{"count":37,"type":38},1000,"ESTIMATED",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44},"BEHAVIORAL","Fit2Lead Group 1-2","Each park serves anywhere from 2 to 9 feeder schools within these neighborhoods (a target population of 34 000 youth residents aged 12-17 years), and transportation from schools to parks is provided at no cost within a 3-mile radius of a program park. Fit2Lead participants can also enroll in the MDPROS youth summer camp at no charge.\n\nWork assignments support MDPROS operations and recreation staff. Interns in Phase II rotate every 8 weeks for exposure to different job opportunities, supervisors, and mentors.\n\nDuke is conducting a secondary data analysis on data collected as part of the Fit2Lead study.",[45],"Fit2 Lead Cohort 1-2",[47,50,52,54,56,58,60,63,66,69,72,75,78,81,84],{"measure":48,"timeFrame":49},"Change in Weight","Baseline, 12-72 months",{"measure":51,"timeFrame":49},"Change in Blood Pressure",{"measure":53,"timeFrame":49},"Change in number of push-ups",{"measure":55,"timeFrame":49},"Change in number of sit-ups",{"measure":57,"timeFrame":49},"Change in Career and Education Planning survey",{"measure":59,"timeFrame":49},"Change in College and Career Readiness survey",{"measure":61,"description":62,"timeFrame":49},"Change in Kidscreen-27","The Kidscreen-27 score range is 27-135. A higher score indicates more positive well-being.",{"measure":64,"description":65,"timeFrame":49},"Change in Generalized Anxiety Disorder 7-item (GAD-7)","The GAD-7 has a score range 0-21. Higher score indicates higher anxiety levels.",{"measure":67,"description":68,"timeFrame":49},"Change in Patient Health Questionnaire-8 (PHQ-8)","The PHQ-8 has a score range 0-24. Higher score indicates higher depression levels.",{"measure":70,"description":71,"timeFrame":49},"Change in the Progressive Aerobic Cardiovascular Endurance Run (PACER) score","Among boys, for ages 10-17, the healthy fitness range is 23-61 laps for age 10, 23-72 laps for age 11, 32-72 laps for age 12, and 41-83 laps for ages 13 and up; Among girls, for ages 10-17, the healthy fitness range is 7-41 laps for age 10, 15-41 laps for ages 11 and 12, and 23-51 laps for ages 13 and up. A higher score indicates greater aerobic capacity.",{"measure":73,"description":74,"timeFrame":49},"Change in Brief Sense of Community Scale (BSCS)","The Brief Sense of Community Scale (BSCS) has a total score range of 0-32. Higher score indicates more positive sense of community.",{"measure":76,"description":77,"timeFrame":49},"Change in Sociopolitical Control Scale for Youth (SCPS-Y; Leadership subscale)","The SCPS-Y has a range 1-6. Higher scores indicate higher policy control, leadership competence, sense of community, ethnic identity, and social support.",{"measure":79,"description":80,"timeFrame":49},"Change in Self-efficacy for teen conflict (SE-TCS)","Possible range for the SE-TCS is 5 to 25' with higher scores indicating more confidence",{"measure":82,"description":83,"timeFrame":49},"Change in Casey Life Skills Assessment","Casey Life Skills Assessment (CLSA) scores are on a scale of 1-5, with 5 representing the highest level of strength",{"measure":85,"description":86,"timeFrame":49},"Change in Perceived Stress Scale (PSS)","The Perceived Stress Scale (PSS) has a score range of 0 to 40, with higher scores indicating greater perceived stress.",[],"ALL","12 Years","17 Years",true,{"inclusion":93,"exclusion":96,"raw_text":99},[94,95],"All participants enrolled in the Miami-Dade Fit2Lead study will be included in this secondary analysis","Aged 12-17 years, residing in Miami-Dade County",[97,98],"Anyone not enrolled in the Miami-Dade Fit2Lead study will be excluded from this secondary analysis","Aged \\<12 or \\>17 years, not residing in Miami-Dade County, cannot read and speak in English","Inclusion Criteria:\n\n* All participants enrolled in the Miami-Dade Fit2Lead study will be included in this secondary analysis\n* Aged 12-17 years, residing in Miami-Dade County\n\nExclusion Criteria:\n\n* Anyone not enrolled in the Miami-Dade Fit2Lead study will be excluded from this secondary analysis\n* Aged \\<12 or \\>17 years, not residing in Miami-Dade County, cannot read and speak in English",[101],"CHILD",[103],{"facility":104,"status":7,"city":105,"state":106,"zip":107,"country":108,"geoPoint":109},"Miami-Dade County Parks, Recreation and Open Spaces Department","Miami","Florida","33128","United States",{"lat":110,"lon":111},25.77427,-80.19366,[113],{"name":114,"role":115,"email":116},"Emily D'Agostino","CONTACT","Emily.M.D'Agostino@duke.edu",[118],{"name":114,"affiliation":12,"role":119},"PRINCIPAL_INVESTIGATOR",[121,125,128,131,134],{"pmid":122,"type":123,"citation":124},"31241997","BACKGROUND","D'Agostino EM, Frazier SL, Hansen E, Patel HH, Ahmed Z, Okeke D, Nardi MI, Messiah SE. Two-Year Changes in Neighborhood Juvenile Arrests After Implementation of a Park-Based Afterschool Mental Health Promotion Program in Miami-Dade County, Florida, 2015-2017. Am J Public Health. 2019 Jun;109(S3):S214-S220. doi: 10.2105\u002FAJPH.2019.305050.",{"pmid":126,"type":123,"citation":127},"31995210","D'Agostino E, Frazier SL, Hansen E, Nardi MI, Messiah SE. Association of a Park-Based Violence Prevention and Mental Health Promotion After-School Program With Youth Arrest Rates. JAMA Netw Open. 2020 Jan 3;3(1):e1919996. doi: 10.1001\u002Fjamanetworkopen.2019.19996.",{"pmid":129,"type":123,"citation":130},"33914915","Goodman AC, Ouellette RR, D'Agostino EM, Hansen E, Lee T, Frazier SL. Promoting healthy trajectories for urban middle school youth through county-funded, parks-based after-school programming. J Community Psychol. 2021 Sep;49(7):2795-2817. doi: 10.1002\u002Fjcop.22587. Epub 2021 Apr 29.",{"pmid":132,"type":123,"citation":133},"31002394","Frazier SL, Chou T, Ouellette RR, Helseth SA, Kashem ER, Cromer KD. Workforce Support for Urban After-School Programs: Turning Obstacles into Opportunities. Am J Community Psychol. 2019 Jun;63(3-4):430-443. doi: 10.1002\u002Fajcp.12328. Epub 2019 Apr 19.",{"pmid":135,"type":123,"citation":136},"31094433","Cromer KD, D'Agostino EM, Hansen E, Alfonso C, Frazier SL. After-school poly-strengths programming for urban teens at high risk for violence exposure. Transl Behav Med. 2019 May 16;9(3):541-548. doi: 10.1093\u002Ftbm\u002Fibz013.",[],{"nct_id":4,"conditions":139,"biomarkers":141},[18,21,140,22],"Obesity",[],{"nct_id":4,"found":91,"summary":143,"prompt_version":34},{"design":144,"status":145,"heading":146,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This is an observational study, meaning researchers will watch and collect data from 1000 participants already enrolled in the Fit2Lead program.","completed","Fit2Lead Park-Based Programs for Youth Health","This study, called Fit2Lead, looks at how a park-based afterschool program affects the health and well-being of young people. Researchers are studying participants aged 12-17 in Miami-Dade County who are part of the Fit2Lead program. This program offers activities like academic support, sports, meditation, and life skills training. The study will track changes in participants' weight, blood pressure, and physical fitness (like how many push-ups they can do) over several years. The goal is to understand if these programs help with anxiety, overall wellness, and issues like being overweight or having high blood pressure.","Participants will be followed for 12 to 72 months to measure changes in weight, blood pressure, and number of push-ups.",94,"Not specified in the trial record.","Not stated in the trial record.",[]]