- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06596265
Community Park-Based Programs for Health Promotion: The Fit2Lead Prospective Cohort Study (F2L)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Fit2Lead 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.
Phase 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emily D'Agostino
- Email: Emily.M.D'Agostino@duke.edu
Study Locations
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Florida
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Miami, Florida, United States, 33128
- Recruiting
- Miami-Dade County Parks, Recreation and Open Spaces Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Fit2 Lead Cohort 1-2
Fit2Lead runs September through June at no charge, and provides daily academic support, sports and recreation, meditation, stress resilience, and life skills-focused workshops.
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.
|
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. Work assignments support MDPROS operations and recreation staff. Interns in Phase II rotate every 8 weeks for exposure to different job opportunities, supervisors, and mentors. Duke is conducting a secondary data analysis on data collected as part of the Fit2Lead study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Weight
Time Frame: Baseline, 12-72 months
|
Baseline, 12-72 months
|
|
|
Change in Blood Pressure
Time Frame: Baseline, 12-72 months
|
Baseline, 12-72 months
|
|
|
Change in number of push-ups
Time Frame: Baseline, 12-72 months
|
Baseline, 12-72 months
|
|
|
Change in number of sit-ups
Time Frame: Baseline, 12-72 months
|
Baseline, 12-72 months
|
|
|
Change in Career and Education Planning survey
Time Frame: Baseline, 12-72 months
|
Baseline, 12-72 months
|
|
|
Change in College and Career Readiness survey
Time Frame: Baseline, 12-72 months
|
Baseline, 12-72 months
|
|
|
Change in Kidscreen-27
Time Frame: Baseline, 12-72 months
|
The Kidscreen-27 score range is 27-135.
A higher score indicates more positive well-being.
|
Baseline, 12-72 months
|
|
Change in Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame: Baseline, 12-72 months
|
The GAD-7 has a score range 0-21.
Higher score indicates higher anxiety levels.
|
Baseline, 12-72 months
|
|
Change in Patient Health Questionnaire-8 (PHQ-8)
Time Frame: Baseline, 12-72 months
|
The PHQ-8 has a score range 0-24.
Higher score indicates higher depression levels.
|
Baseline, 12-72 months
|
|
Change in the Progressive Aerobic Cardiovascular Endurance Run (PACER) score
Time Frame: Baseline, 12-72 months
|
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.
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Baseline, 12-72 months
|
|
Change in Brief Sense of Community Scale (BSCS)
Time Frame: Baseline, 12-72 months
|
The Brief Sense of Community Scale (BSCS) has a total score range of 0-32.
Higher score indicates more positive sense of community.
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Baseline, 12-72 months
|
|
Change in Sociopolitical Control Scale for Youth (SCPS-Y; Leadership subscale)
Time Frame: Baseline, 12-72 months
|
The SCPS-Y has a range 1-6.
Higher scores indicate higher policy control, leadership competence, sense of community, ethnic identity, and social support.
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Baseline, 12-72 months
|
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Change in Self-efficacy for teen conflict (SE-TCS)
Time Frame: Baseline, 12-72 months
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Possible range for the SE-TCS is 5 to 25' with higher scores indicating more confidence
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Baseline, 12-72 months
|
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Change in Casey Life Skills Assessment
Time Frame: Baseline, 12-72 months
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Casey Life Skills Assessment (CLSA) scores are on a scale of 1-5, with 5 representing the highest level of strength
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Baseline, 12-72 months
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Change in Perceived Stress Scale (PSS)
Time Frame: Baseline, 12-72 months
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The Perceived Stress Scale (PSS) has a score range of 0 to 40, with higher scores indicating greater perceived stress.
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Baseline, 12-72 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily D'Agostino, Duke University
Publications and helpful links
General Publications
- 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/AJPH.2019.305050.
- 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/jcop.22587. Epub 2021 Apr 29.
- 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/jamanetworkopen.2019.19996.
- 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/ajcp.12328. Epub 2019 Apr 19.
- 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/tbm/ibz013.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Mental Disorders
- Nutrition Disorders
- Overnutrition
- Body Weight
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Personal Satisfaction
- Overweight
- Obesity
- Hypertension
- Anxiety Disorders
- Prehypertension
- Psychological Well-Being
Other Study ID Numbers
- Pro00105669_2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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