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CVDNCT06602596

Hoosier Sport: Refining and Implementing a Sustainable Campus-Community Partnership in Rural Indiana

A study testing Hoosier Sport in people with CVD and Cardiovascular Diseases, run by Indiana University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hoosier Sport is a sport-based youth development program that uses the power of sport to teach children and adolescents sport and leadership skills while promoting health education. Read more about this study

Who is it for?
Ages 10 to 18 yearsHealthy volunteers can take part
Conditions the study is for
CVD, Cardiovascular Diseases
What is being tested?
Hoosier Sport
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesUnited States
Study dates
1 Oct 2024to 15 May 2025
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 10 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Must provide parental consent and student assent.
  • Enrollment in a physical education class

Who cannot join

  • -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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Indiana University

    Bloomington, Indiana, 47405

  • White River Valley Middle School

    Lyons, Indiana, 47443

Other trials in United States

About this study

Hoosier Sport is a sport-based youth development program that uses the power of sport to teach children and adolescents sport and leadership skills while promoting health education. Conducted in rural middle and high schools, the program aims to enhance health and wellness by incorporating unique sports such as volleyball and flag football, along with leadership activities like goal setting and health education on the importance of exercise and a healthy lifestyle. The program runs for eight weeks each semester (Fall and Spring), with sessions twice a week during PE class, where college service-learning students lead the curriculum. Data on physical activity and psychosocial factors are collected to assess changes in health, ensuring confidentiality through strict IRB protocols.

Read the 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.

Being tested
Hoosier Sport
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hoosier SportBehavioural

    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.

Study groups in NCT06602596
Study groupRoleWhat they receive
Control groupNo interventionThe 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.
Test group - Hoosier Sport ParticipantsExperimentalThe 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.
Receives: Behavioral: Hoosier Sport

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Intervention Measure (FIM)

    How feasible the intervention was from the perspective of the participants. This is measured through questionnaire.

    Measured: Measured at week 0 and week 9

  2. Acceptability of Intervention Measure (IAM)

    How acceptable the intervention is to the participants. This is measured through questionnaire.

    Measured: Measured at week 0 and week 9

  3. Intervention Appropriateness Measure (AIM)

    How appropriate the intervention is to the participants. This is measured through questionnaire.

    Measured: Measured at week 0 and week 9

Secondary outcomes (8)
  1. Daily Total Physical Activity of Participants

    Accelerometers (Axivity - AX3 model) will be used to track daily total physical activity

    Measured: Week 1 (for 7 days), and week 9 (for 7 days)

  2. Heart Rate of Participants

    heart rate measured via a blood pressure monitor

    Measured: HR will be taken at week 0 and week 9 before and following the 6-minute walk test.

  3. Blood Pressure of Participants

    Blood pressure measured via a blood pressure monitor

    Measured: BP will be taken at week 0 and week 9 before and following the 6-minute walk test.

  4. Basic Psychological Needs of Participants in Intervention Environment

    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.

    Measured: Assessed at week 0 and week 9

  5. Physical Literacy of Participants

    the Canadian Assessment of Physical Literacy second addition (CAPL-2) will be used. A higher score on the CAPL-2 indicates higher physical literacy.

    Measured: Assessed at week 0 and week 9

  6. Cardiovascular Fitness Levels of Participants

    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.

    Measured: Assessed at week 0 and week 9

  7. Muscular Endurance Levels of Participants

    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.

    Measured: Assessed at week 0 and week 9

  8. Policy, Systems, and Environmental Factors Influencing Participant Physical Activity and Nutrition Behavior.

    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.

    Measured: Assessed at week 0 and week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Oct 2024
  3. Primary completion8 May 2025
  4. Study completion15 May 2025

Resources

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
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06602596
Sponsor's protocol ID
23985
Status last verified
Jul 2025
First submitted
17 Sep 2024
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Callahan SH, King JF, Ortyl BK, Cumming NG, Watkins JM, Goss JM, Martinez Kercher VM, Kercher KA. Feasibility and physical health outcomes of a 1-year sport-based physical activity intervention in rural middle school children. BMC Sports Sci Med Rehabil. 2026 Jan 3;18(1):56. doi: 10.1186/s13102-025-01498-4.

    PubMed 41484781

Questions about this trial

What is this clinical trial studying?

A study testing Hoosier Sport in people with CVD and Cardiovascular Diseases, run by Indiana University at 2 sites 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 2 inclusion and 1 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Feasibility of Intervention Measure (FIM) (time frame: Measured at week 0 and week 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06602596, which also lists 1 linked publication.

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 11 Jul 2025.

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