NCT04975529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

June 3, 2021

Last Update Submit

July 14, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Mean change from baseline in youth self-reported self-efficacy for physical activity using the validated Physical Activity Self-efficacy scale at 6-months

    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

    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

    Change from baseline to end of the 6-month intervention

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education

Comparison Arm

EXPERIMENTAL

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.

Behavioral: Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education

Interventions

Two-group quasi experimental intervention with schools assigned to intervention or comparison.

Comparison ArmIntervention Arm

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years of age or older
  • Parent or legal guardian of the enrolled child
  • Can read, write and speak in English
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Gina L Tripicchio, PhD, MSEd

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two-group quasi-experimental
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

July 23, 2021

Study Start

November 6, 2020

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations