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

The clinical trial aims to develop and pilot test a multilevel physical activity (PA) intervention called the Hoosier Sport program. The study follows a participatory co-design protocol involving youth, parents, and community leaders to provide direct input into the intervention's design. The ultimate goal is to contribute to health equity in the community by promoting sustainable physical activity. Hoosier Sport involves delivering enhanced physical education classes, teaching about nutrition and exercise, as well as developing leadership skills in middle school rural students.The intervention will last for 8-weeks with PE classes occur twice a week. Additionally, Hoosier Sport will create more opportunities for students to be active at school (e.g., in home room) through providing virtual classes and other activities.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Sedentary Behavior
• Intervention / Treatment: Behavioral: Hoosier Sport

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Has PE class the semester during Hoosier Sport-
• Parent provides informed consent

Exclusion Criteria:

• Answer yes to any question on the Physical Activity Readiness for Everybody (PARQ+)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in the intervention arm will receive the Hoosier Sport intervention 2-3 times a week (twice in PE class, and once in home room). This will involve learning new sport, exercise, and nutrition knowledge, as well as developing leadership skills.	Behavioral: Hoosier Sport; Hoosier Sport is a sport-based youth development intervention. The intervention targets physical activity levels, exercise and nutrition knowledge, and leadership skills. The intervention is delivered in person twice a week (Tue/Thu) during PE class. Each class lasts 45-minutes, and covers sport skills, and then a brief lecture and activity on exercise/nutrition/leadership skills. Additionally, once a week Hoosier Sport is delivered virtually (via Zoom) during home room for 20-minutes. This involves activities to allow the students to be active during the school-day.
No Intervention: Control; Participants in the control arm will not receive the Hoosier Sport intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Intervention Measure (FIM)	How feasible the intervention was from the perspective of the participants. This is measured through questionnaire.	Measured at week 0 and week 9
Acceptability of Intervention Measure (IAM)	How acceptable the intervention is to the participants. This is measured through questionnaire.	Measured at week 0 and week 9
Intervention Appropriateness Measure (AIM)	How appropriate the intervention is to the participants. This is measured through questionnaire.	Measured at week 0 and week 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Steps of Participants	Accelerometers (Axivity - AX3 model) will be used to track daily steps	Week 1 (for 7 days), and week 9 (for 7 days)
Daily Moderate to Vigorous Physical Activity of Participants	Accelerometers (Axivity - AX3 model) will be used to track daily MVPA	Week 1 (for 7 days), and week 9 (for 7 days)
Heart Rate of Participants	heart rate measured via a blood pressure monitor	HR will be taken at week 0 and week 9 before and following the 6-minute walk test.
Blood Pressure of Participants	Blood pressure measured via a blood pressure monitor	BP will be taken at week 0 and week 9 before and following the 6-minute walk test.
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.	Assessed at week 0 and week 9
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.	Assessed at week 0 and week 9
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.	Assessed at week 0 and week 9
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.	Assessed at week 0 and week 9
Self-Reported Weekly Moderate to Vigorous Physical Activity of Participants	The Canadian Assessment of Physical Literacy Second Edition (CAPL-2) will be used to assess self-reported weekly MVPA.	Assessed at week 0 and week 9
Nutrition Knowledge of Participants	A survey will assess basic knowledge of nutrition. We will use knowledge of SNAP-Ed, the United State Department of Agriculture's recommended curriculum. There will be three questions, with a high score reflecting greater nutrition knowledge.	Assessed at week 0 and week 9
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.	Assessed at week 0 and week 9

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: United States Department of Agriculture (USDA)

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: February 11, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 18784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All individual participant data will be masked and only the PI will have access to the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No