- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06602596
Hoosier Sport: Refining and Implementing a Sustainable Campus-Community Partnership in Rural Indiana
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hoosier Sport is a comprehensive sport-based youth development program designed to enhance the health and wellness of rural children and adolescents. The program leverages the power of sport to teach essential sport skills, leadership qualities, and promote health education. Conducted primarily in physical education (PE) classes, with occasional sessions in health classes, Hoosier Sport spans eight weeks with sessions twice a week. The curriculum focuses on unique sports such as strength training, pickleball, and flag football, and integrates activities that foster leadership (e.g., goal setting) and health education (e.g., the importance of regular exercise and a healthy lifestyle).
A key objective of Hoosier Sport is to explore how participation in sports can satisfy the basic psychological needs of autonomy, competence, and relatedness. By providing structured yet flexible activities that allow for individual achievement and peer interaction, the program aims to enhance students' intrinsic motivation to engage in physical activity. Additionally, Hoosier Sport addresses the growing concern of screen time and social media usage, which are known to negatively impact physical activity levels. The program integrates discussions and activities that encourage students to reflect on their screen time habits, understand the effects of social media on body image and activity levels, and develop healthier behaviors.
To objectively measure the impact of the program on physical activity (PA), Hoosier Sport utilizes advanced accelerometers (AX3 devices). These devices are worn by students for a week at a time, capturing detailed data on their physical activity patterns. This data allows the research team to accurately assess changes in PA levels throughout the program, providing insights into the effectiveness of the intervention. Alongside physical activity, the program collects data on psychosocial factors, such as self-esteem and social skills, to identify broader health and behavioral outcomes. Exploratory data includes screen time, social media usage, as well as inhibitory control. All collected data is handled anonymously, following strict Institutional Review Board (IRB) protocols to ensure the privacy and protection of participants. Through this multifaceted approach, Hoosier Sport aims not only to improve physical health but also to foster psychological well-being and sustainable healthy behaviors among rural youth.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Indiana
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Bloomington, Indiana, United States, 47405
- Indiana University
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Lyons, Indiana, United States, 47443
- White River Valley Middle School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must provide parental consent and student assent.
- Enrollment in a physical education class
Exclusion Criteria:
-Presence of medical conditions or physical limitations that prevent safe participation in physical activity, as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or a medical professional.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
The control group in the Hoosier Sport study consists of students who are not enrolled in the PE class and therefore do not participate in the Hoosier Sport program.
These students continue with their regular school activities without the added sport, leadership, and health education components provided in the intervention.
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Experimental: Test group - Hoosier Sport Participants
The intervention group in the Hoosier Sport study consists of students enrolled in the PE class who actively participate in the Hoosier Sport program.
These students engage in an 8-week curriculum that includes unique sports activities, leadership exercises, and health education sessions designed to promote physical activity and well-being.
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The Hoosier Sport intervention is an 8-week program designed for students in PE classes, focusing on enhancing physical activity and promoting health through sport.
The curriculum includes unique sports activities, leadership exercises, and health education, aimed at improving students' physical and psychological well-being.
The program also addresses the effects of screen time and social media on physical activity, encouraging healthier behaviors.
Throughout the intervention, students wear AX3 accelerometers to track changes in their physical activity levels, helping to assess the program's impact.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Intervention Measure (FIM)
Time Frame: Measured at week 0 and week 9
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How feasible the intervention was from the perspective of the participants.
This is measured through questionnaire.
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Measured at week 0 and week 9
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Acceptability of Intervention Measure (IAM)
Time Frame: Measured at week 0 and week 9
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How acceptable the intervention is to the participants.
This is measured through questionnaire.
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Measured at week 0 and week 9
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Intervention Appropriateness Measure (AIM)
Time Frame: Measured at week 0 and week 9
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How appropriate the intervention is to the participants.
This is measured through questionnaire.
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Measured at week 0 and week 9
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate of Participants
Time Frame: HR will be taken at week 0 and week 9 before and following the 6-minute walk test.
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heart rate measured via a blood pressure monitor
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HR will be taken at week 0 and week 9 before and following the 6-minute walk test.
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Blood Pressure of Participants
Time Frame: BP will be taken at week 0 and week 9 before and following the 6-minute walk test.
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Blood pressure measured via a blood pressure monitor
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BP will be taken at week 0 and week 9 before and following the 6-minute walk test.
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Basic Psychological Needs of Participants in Intervention Environment
Time Frame: Assessed at week 0 and week 9
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Basic Psychological Needs and Satisfaction and Frustration scale (BPNSF).
This entails feelings/perceptions of autonomy, relatedness, competence, enjoyment, satisfaction, and frustration in the study setting.
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Assessed at week 0 and week 9
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Physical Literacy of Participants
Time Frame: Assessed at week 0 and week 9
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the Canadian Assessment of Physical Literacy second addition (CAPL-2) will be used.
A higher score on the CAPL-2 indicates higher physical literacy.
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Assessed at week 0 and week 9
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Cardiovascular Fitness Levels of Participants
Time Frame: Assessed at week 0 and week 9
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the 6-minute walk test will be used to assess changes in fitness.
Greater distance walked in the 6 minute time frame is related to greater levels of cardiovascular fitness.
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Assessed at week 0 and week 9
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Muscular Endurance Levels of Participants
Time Frame: Assessed at week 0 and week 9
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The plank test will be used to assess changes in fitness.
The longer the plank is held, the greater the muscular endurance of the participant.
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Assessed at week 0 and week 9
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Policy, Systems, and Environmental Factors Influencing Participant Physical Activity and Nutrition Behavior.
Time Frame: Assessed at week 0 and week 9
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a survey will collect data on Policy, Systems and Environmental (PSE) changes using a 5 questions guided by the SNAP-Ed curriculum.
Higher scores will indicate better PSE support for physical activity and healthy nutrition opportunities for the participants in their school environment.
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Assessed at week 0 and week 9
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Daily Total Physical Activity of Participants
Time Frame: Week 1 (for 7 days), and week 9 (for 7 days)
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Accelerometers (Axivity - AX3 model) will be used to track daily total physical activity
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Week 1 (for 7 days), and week 9 (for 7 days)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily screen time
Time Frame: Assessed at week 0 and week 9
|
data from participants' phone settings will be used to capture daily screen time.
Participants will navigate to their screen time settings, where a comprehensive and objective report of their weekly screen time (including average daily screen time) is available.
Here, participants will screenshot this data and airdrop it to a secured IU dropbox location.
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Assessed at week 0 and week 9
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Daily social media usage
Time Frame: Assessed at week 0 and week 9
|
data from participants' phone settings will be used to capture daily screen time.
Participants will navigate to their screen time settings, where a comprehensive and objective report of their weekly screen time (including average daily social media usage) is available.
Here, participants will screenshot this data and airdrop it to a secured IU dropbox location.
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Assessed at week 0 and week 9
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Social media addiction
Time Frame: Assessed at week 0 and week 9
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participants will complete the Bergen Social Media Addiction Scale to assess social media addiction.
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Assessed at week 0 and week 9
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Inhibitory control
Time Frame: Assessed at week 0 and week 9
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The Color-Word trial from the Stroop Color and Word Test will be delivered on an iPad/tablet to participants to measure inhibitory control.
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Assessed at week 0 and week 9
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23985
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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