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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06280859
Other study ID # 18784
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 20, 2024
Est. completion date June 10, 2024

Study information

Verified date March 2024
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 34
Est. completion date June 10, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Indiana University Bloomington Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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)
Secondary 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)
Secondary 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.
Secondary 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.
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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