- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06556719
- Original Trial
Hoosier Sport Re-Social: A Biobehavioral Intervention in Rural Indiana
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hoosier Sport Re-Social is a comprehensive, sport-based intervention designed to address the dual challenges of low physical activity (PA) and high social media use among children in under-resourced rural areas. This innovative program aims to reduce cardiovascular disease (CVD) risk by promoting healthier behaviors through the integration of physical activity and social media literacy (SML) training. Recognizing that CVD is a leading cause of death, particularly in under-resourced populations, and that fewer than one in five U.S. children meet the recommended PA levels-especially in rural areas-this intervention targets a significant public health need.
The program is designed to be implemented within the school setting, leveraging both physical education (PE) and health classes to deliver its core components. The PA portion of the intervention takes place during PE classes, where students engage in structured sport activities aimed at increasing daily physical activity levels. This component is designed to enhance students' fitness, build confidence in their physical abilities, and foster a lifelong interest in staying active.
Complementing the physical activity focus, the SML portion is integrated into health classes. Here, students are educated about the impacts of social media on health, particularly its role in influencing behavior and well-being. The curriculum equips students with the knowledge and skills to critically analyze social media content, make informed decisions about their digital consumption, and develop healthier online habits.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47405
- Indiana University
-
Lyons, Indiana, United States, 47443
- White River Valley Middle School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- enrolled in 7th-9th grade
- provides parental consent
- provides assent
Exclusion Criteria:
- Inability to attend school regularly during the 6-week intervention period
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 |
|---|---|
|
Experimental: Hoosier Sport Re-Social Participants
Arm will receive 6-weeks of intervention, including enhanced PE and health class curriculum
|
Hoosier Sport Re-Social is a 6-week school-based intervention designed to reduce cardiovascular disease risk in rural children.
It includes twice-weekly physical activity sessions during PE classes and weekly social media literacy training in health classes, promoting healthier physical and digital behaviors.
|
|
No Intervention: Regular Health and PE Participants
Arm will receive regular PE and health class curriculum
|
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 6
|
How feasible the intervention was from the perspective of the participants.
This is measured through questionnaire.
|
Measured at week 0 and week 6
|
|
Acceptability of Intervention Measure (IAM)
Time Frame: Measured at week 0 and week 6
|
How acceptable the intervention is to the participants.
This is measured through questionnaire.
|
Measured at week 0 and week 6
|
|
Intervention Appropriateness Measure (AIM)
Time Frame: Measured at week 0 and week 6
|
How appropriate the intervention is to the participants.
This is measured through questionnaire.
|
Measured at week 0 and week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily Total Physical Activity of Participants
Time Frame: Week 1 (for 7 days), and week 6 (for 7 days)
|
Accelerometers (Axivity - AX3 model) will be used to track total daily physical activity
|
Week 1 (for 7 days), and week 6 (for 7 days)
|
|
Heart Rate of Participants
Time Frame: HR will be taken at week 0 and week 6 before and following the 6-minute walk test.
|
heart rate measured via a blood pressure monitor
|
HR will be taken at week 0 and week 6 before and following the 6-minute walk test.
|
|
Blood Pressure of Participants
Time Frame: BP will be taken at week 0 and week 6 before and following the 6-minute walk test.
|
Blood pressure measured via a blood pressure monitor
|
BP will be taken at week 0 and week 6 before and following the 6-minute walk test.
|
|
Basic Psychological Needs of Participants in Intervention Environment
Time Frame: Assessed at week 0 and week 6
|
Basic Psychological Needs and Satisfaction and Frustration scale.
This entails feelings/perceptions of autonomy, relatedness, competence, enjoyment, satisfaction, and frustration in the study setting.
Higher scores indicate greater satisfaction.
|
Assessed at week 0 and week 6
|
|
Physical Literacy of Participants
Time Frame: Assessed at week 0 and week 6
|
the Canadian Assessment of Physical Literacy second addition (CAPL-2) will be used.
A higher score on the CAPL-2 indicates higher physical literacy.
|
Assessed at week 0 and week 6
|
|
Cardiovascular Fitness Levels of Participants
Time Frame: Assessed at week 0 and week 6
|
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.
|
Assessed at week 0 and week 6
|
|
Muscular Endurance Levels of Participants
Time Frame: Assessed at week 0 and week 6
|
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.
|
Assessed at week 0 and week 6
|
|
Daily screen time
Time Frame: Assessed at week 0 and week 6
|
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.
|
Assessed at week 0 and week 6
|
|
Daily social media usage
Time Frame: Assessed at week 0 and week 6
|
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.
|
Assessed at week 0 and week 6
|
|
Social media addiction
Time Frame: Assessed at week 0 and week 6
|
participants will complete the Bergen Social Media Addiction Scale to assess social media addiction.
|
Assessed at week 0 and week 6
|
|
Inhibitory control
Time Frame: Assessed at week 0 and week 6
|
The Color-Word trial from the Stroop Color and Word Test will be delivered on an iPad/tablet to participants to measure inhibitory control.
|
Assessed at week 0 and week 6
|
|
Body Satisfaction
Time Frame: Assessed at week 0 and week 6
|
The Body Satisfaction Questionnaire (BSQ) will be completed to assess participants satisfaction of their body shape.
|
Assessed at week 0 and week 6
|
|
Body Appreciation
Time Frame: Assessed at week 0 and week 6
|
The Body Appreciation Scale (version 2) (BAS-2) will be completed to assess participants' appreciation of their bodies.
|
Assessed at week 0 and week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kyle Kercher, PhD, Indiana University
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
Other Study ID Numbers
- 21473
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
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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