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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2021
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
Two-group quasi experimental intervention with schools assigned to intervention or comparison.

Locations

Country Name City State
United States Temple University Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Temple University Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

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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