ExerciseNCT04975529
Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
A study testing Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education in people with Exercise and Diet, run by Temple University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- What is being tested?
- Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2020to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 18 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition EducationBehavioural
Two-group quasi experimental intervention with schools assigned to intervention or comparison.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Youth self-reported self-efficacy for physical activity
Measured: 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
Youth self-reported dietary intake
Measured: 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
Youth self-reported confidence
Measured: Change from baseline to end of the 6-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start6 Nov 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-group quasi-experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Gina L Tripicchio, PhD, MSEd, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975529
- Sponsor's protocol ID
- 26406
- Status last verified
- Jul 2021
- First submitted
- 3 Jun 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
- ClinicalTrials.gov ID
- NCT04975529
- Acronym / sponsor ID
- 26406
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-group quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition EducationParticipants 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. |
| Comparison Arm | Experimental | Behavioral: Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition EducationParticipants 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. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition EducationTwo-group quasi experimental intervention with schools assigned to intervention or comparison. | Behavioural | Comparison Arm, Intervention Arm |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina L Tripicchio, PhD, MSEd principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education in people with Exercise and Diet, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.