AnxietyF2LNCT06596265
Community Park-Based Programs for Health Promotion: The Fit2Lead Prospective Cohort Study
An observational study of Anxiety and Wellness, Psychological, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Wellness, Psychological, Overweight or Obesity
- What is being tested?
- Fit2Lead Group 1-2
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2016to 17 Jun 2028
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Fit2Lead is offered in areas composed of 48% male youths, 60% Hispanic persons, 29% non-Hispanic Black persons, 33% single-parent households, and 33% of residents living below the federal poverty threshold as defined by the American Community Survey. Thirty-three percent of families are single-parent households, and 33% of residents are living in poverty in zip codes where Fit2Lead is offered.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily D'Agostino contact
United States1 site, 1 recruiting
- Recruiting
Miami-Dade County Parks, Recreation and Open Spaces Department
Miami, Florida, 33128
About this study
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.
Read the 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.
- Conditions
- Anxiety, Wellness, Psychological, Overweight or Obesity, Hypertension, Prehypertension, Low Physical Fitness
- Being tested
- Fit2Lead Group 1-2
- Keywords
- Youth, Adolescent, Afterschool, Parks and Recreation, Mental Health, Physical Helath, Resilience, Violence Prevention
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being, Overweight, Obesity, Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit2Lead Group 1-2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Fit2Lead Group 1-2 |
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 Blood Pressure
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 Career and Education Planning survey
Measured: Baseline, 12-72 months
Change in College and Career Readiness survey
Measured: Baseline, 12-72 months
Change in Kidscreen-27
The Kidscreen-27 score range is 27-135. A higher score indicates more positive well-being.
Measured: Baseline, 12-72 months
Change in Generalized Anxiety Disorder 7-item (GAD-7)
The GAD-7 has a score range 0-21. Higher score indicates higher anxiety levels.
Measured: Baseline, 12-72 months
Change in Patient Health Questionnaire-8 (PHQ-8)
The PHQ-8 has a score range 0-24. Higher score indicates higher depression levels.
Measured: Baseline, 12-72 months
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.
Measured: Baseline, 12-72 months
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.
Measured: Baseline, 12-72 months
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.
Measured: Baseline, 12-72 months
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
Measured: Baseline, 12-72 months
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
Measured: Baseline, 12-72 months
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.
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 start17 Feb 2016
- Primary completion17 Jun 2028 (estimated)
- Study completion17 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- 1,000 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, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596265
- Sponsor's protocol ID
- Pro00105669_2
- Acronym
- F2L
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2024
- Last updated
- 10 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, 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.
PubMed 31241997D'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.
PubMed 31995210Goodman 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.
PubMed 33914915Frazier 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.
PubMed 31002394Cromer 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.
PubMed 31094433
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Park-Based Programs for Health Promotion: The Fit2Lead Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06596265
- Acronym / sponsor ID
- F2L / Pro00105669_2
- Conditions
- Anxiety, Wellness, Psychological, Overweight or Obesity, Hypertension, Prehypertension, Low Physical Fitness
- Keywords
- Youth, Adolescent, Afterschool, Parks and Recreation, Mental Health, Physical Helath, Resilience, Violence Prevention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Miami-Dade County Parks and Recreation, The Children's Trust, Miami FL
- Study start
- 17 Feb 2016 (actual)
- Primary completion
- 17 Jun 2028 (estimated)
- Study completion
- 17 Jun 2028 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fit2 Lead Cohort 1-2 | – | Behavioral: Fit2Lead Group 1-2Fit2Lead 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Fit2Lead is offered in areas composed of 48% male youths, 60% Hispanic persons, 29% non-Hispanic Black persons, 33% single-parent households, and 33% of residents living below the federal poverty threshold as defined by the American Community Survey. Thirty-three percent of families are single-parent households, and 33% of residents are living in poverty in zip codes where Fit2Lead is offered.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Fit2Lead Group 1-2Each 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. | Behavioural | Fit2 Lead Cohort 1-2 |
Primary outcome
Change in Weight
Time frame: Baseline, 12-72 months
Change in Blood Pressure
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 Career and Education Planning survey
Time frame: Baseline, 12-72 months
Change in College and Career Readiness survey
Time frame: 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.
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.
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.
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.
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.
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.
Change in Self-efficacy for teen conflict (SE-TCS)
Time frame: Baseline, 12-72 months
Possible range for the SE-TCS is 5 to 25' with higher scores indicating more confidence
Change in Casey Life Skills Assessment
Time frame: Baseline, 12-72 months
Casey Life Skills Assessment (CLSA) scores are on a scale of 1-5, with 5 representing the highest level of strength
Change in Perceived Stress Scale (PSS)
Time frame: Baseline, 12-72 months
The Perceived Stress Scale (PSS) has a score range of 0 to 40, with higher scores indicating greater perceived stress.
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 10 Sep 2025.
- Background: PubMed 31241997D'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.
- Background: PubMed 31995210D'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.
- Background: PubMed 33914915Goodman 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.
- Background: PubMed 31002394Frazier 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.
- Background: PubMed 31094433Cromer 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.
- 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 contact
Emily D'Agostino 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 Anxiety and Wellness, Psychological, 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 2 inclusion and 2 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 10 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 D'Agostino (Emily.M.D'Agostino@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 15 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 NCT06596265, which also lists 5 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 10 Sep 2025.