Exercise Clinical Trial
Official title:
Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
NCT number | NCT04975529 |
Other study ID # | 26406 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 6, 2020 |
Est. completion date | July 15, 2021 |
Verified date | July 2021 |
Source | Temple University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Game on Philly is a multi-component out-of-school time intervention delivered by trained sport-based youth development coaches and health navigators using evidenced-based programming. The program evaluation assesses the impact of this minimal-risk intervention to reduce the prevalence of obesity-related health disparities in racial and ethnic minority middle school youth. The program is a virtual sport-based youth development program, supplemented with nutrition education. The program was modified due to Covid-19 and is entirely virtual. Using a quasi-experimental design, six schools are assigned to the intervention arm and six schools are assigned to the comparison arm. Participants in intervention schools receive access to daily, online after school programming, with live sessions with sports providers (via Zoom), weekly team meetings with a health coach (via Zoom), text-messages via the Remind app, and the monthly delivery of Activity Kits directly to their homes for six months. Comparison school participants receive access to the Game on Philly app with workout and sports content and receive one activity kit delivery at the start of the program. Parent-child dyads recruited from each school complete surveys at baseline and at the end of the 6-month program (follow-up). It is hypothesized that youth participating in the intervention will experience significantly greater increases in physical activity at the end of the 6-month intervention compared to youth participating in the comparison arm (primary outcome). Secondary outcomes will examine changes in dietary intake, self-efficacy for physical activity and positive youth development.
Status | Completed |
Enrollment | 96 |
Est. completion date | July 15, 2021 |
Est. primary completion date | July 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 15 Years |
Eligibility | Inclusion Criteria (Parents) : - 18 years of age or older - Parent or legal guardian of the enrolled child - Can read, write and speak in English Inclusion Criteria (Child): - Interested in and able to participate in the program for 6-months - Can read, write and speak in English - Are in 6th, 7th or 8th grade at a participating school |
Country | Name | City | State |
---|---|---|---|
United States | Temple University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University | Department of Health and Human Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change from baseline in youth self-reported physical activity using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure at 6-months | Youth self-reported physical activity | Change from baseline to end of the 6-month intervention | |
Secondary | Mean change from baseline in youth self-reported self-efficacy for physical activity using the validated Physical Activity Self-efficacy scale at 6-months | Youth self-reported self-efficacy for physical activity | Change from baseline to end of the 6-month intervention | |
Secondary | Mean change from baseline in youth self-reported dietary intake assessed using the National Cancer Institute (NCI) fruit and vegetable screener at 6-months | Youth self-reported dietary intake | Change from baseline to end of the 6-month intervention | |
Secondary | Mean change from baseline in youth self-confidence assessed using the Positive Youth Development (PYD) Short Form Confidence scale at 6-months | Youth self-reported confidence | Change from baseline to end of the 6-month intervention |
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