Cardiovascular Diseases Clinical Trial
Official title:
Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana
Verified date | March 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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+) |
Country | Name | City | State |
---|---|---|---|
United States | Indiana University | Bloomington | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | United States Department of Agriculture (USDA) |
United States,
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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