- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04975529
Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
July 14, 2021 updated by: Temple University
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
Participants in intervention schools received access to daily, online after school programming, including live sessions with sports providers (via Zoom; rotating to provide exposure to multiple sports over the course of the intervention), weekly team meetings with a health coach (via Zoom), text-messages via the Remind app, and monthly delivery of Activity Kits with sports equipment, activity books, fresh produce, and incentives directly to their homes over 6-months.
|
Two-group quasi experimental intervention with schools assigned to intervention or comparison.
|
|
Experimental: Comparison Arm
Participants in comparison schools received access to the Game on Philly app with workout and sports content that could be used asynchronously, and received one activity kit delivery with sports equipment and a self-guided activity book at the start of the program.
|
Two-group quasi experimental intervention with schools assigned to intervention or comparison.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change from baseline in youth self-reported physical activity using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure at 6-months
Time Frame: Change from baseline to end of the 6-month intervention
|
Youth self-reported physical activity
|
Change from baseline to end of the 6-month intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean change from baseline in youth self-reported self-efficacy for physical activity using the validated Physical Activity Self-efficacy scale at 6-months
Time Frame: Change from baseline to end of the 6-month intervention
|
Youth self-reported self-efficacy for physical activity
|
Change from baseline to end of the 6-month intervention
|
|
Mean change from baseline in youth self-reported dietary intake assessed using the National Cancer Institute (NCI) fruit and vegetable screener at 6-months
Time Frame: Change from baseline to end of the 6-month intervention
|
Youth self-reported dietary intake
|
Change from baseline to end of the 6-month intervention
|
|
Mean change from baseline in youth self-confidence assessed using the Positive Youth Development (PYD) Short Form Confidence scale at 6-months
Time Frame: Change from baseline to end of the 6-month intervention
|
Youth self-reported confidence
|
Change from baseline to end of the 6-month intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gina L Tripicchio, PhD, MSEd, Temple University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2020
Primary Completion (Actual)
July 15, 2021
Study Completion (Actual)
July 15, 2021
Study Registration Dates
First Submitted
June 3, 2021
First Submitted That Met QC Criteria
July 14, 2021
First Posted (Actual)
July 23, 2021
Study Record Updates
Last Update Posted (Actual)
July 23, 2021
Last Update Submitted That Met QC Criteria
July 14, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 26406
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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