Clinical trial NCT04975529: Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
Official title: Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Diet
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2021-07-23
Enrollment: 96
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group quasi-experimental
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in youth self-reported physical activity using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure at 6-months
timeFrame: Change from baseline to end of the 6-month intervention
Secondary outcomes:
measure: Mean change from baseline in youth self-reported self-efficacy for physical activity using the validated Physical Activity Self-efficacy scale at 6-months
timeFrame: Change from baseline to end of the 6-month intervention
measure: Mean change from baseline in youth self-reported dietary intake assessed using the National Cancer Institute (NCI) fruit and vegetable screener at 6-months
timeFrame: Change from baseline to end of the 6-month intervention
measure: Mean change from baseline in youth self-confidence assessed using the Positive Youth Development (PYD) Short Form Confidence scale at 6-months
timeFrame: Change from baseline to end of the 6-month intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Gina L Tripicchio, PhD, MSEd
role: PRINCIPAL_INVESTIGATOR
References: