An interventional study of Hoosier Sport in Cardiovascular Diseases and Sedentary Behavior, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 9 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Indiana University · Not applicable, Interventional, and Health services research
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 34 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants in the control arm will not receive the Hoosier Sport intervention.
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.
Feasibility of Intervention Measure (FIM)
How feasible the intervention was from the perspective of the participants. This is measured through questionnaire.
Time frame: 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.
Time frame: Measured at week 0 and week 9
Intervention Appropriateness Measure (AIM)
How appropriate the intervention is to the participants. This is measured through questionnaire.
Time frame: Measured at week 0 and week 9
Daily Steps of Participants
Accelerometers (Axivity - AX3 model) will be used to track daily steps
Time frame: 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
Time frame: Week 1 (for 7 days), and week 9 (for 7 days)
Heart Rate of Participants
heart rate measured via a blood pressure monitor
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at week 0 and week 9
Plan to share: No — All individual participant data will be masked and only the PI will have access to the data.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Indiana University