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Behavioral Intervention

Intervention for Cardiovascular Disease

N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 (for 7 days), and week 9 (for 7 days)
Awards & highlights

Study Summary

"This trial aims to test a new physical activity program called Hoosier Sport involving middle school students. The goal is to promote physical activity and health equity in the community by providing enhanced physical education classes,

Who is the study for?
This trial is for middle school students in rural Indiana who have a sedentary lifestyle and are at risk of cardiovascular disease. The program seeks participants willing to engage in an 8-week physical activity intervention, with classes twice a week.Check my eligibility
What is being tested?
The Hoosier Sport program is being tested to see if it can help increase physical activity among youth. It includes enhanced PE classes, nutrition and exercise education, leadership development, virtual classes, and additional school activities.See study design
What are the potential side effects?
Since this trial involves physical activity and education without medical or pharmaceutical interventions, there aren't typical side effects. However, participants may experience muscle soreness or fatigue due to increased activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 (for 7 days), and week 9 (for 7 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 (for 7 days), and week 9 (for 7 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of Intervention Measure (IAM)
Feasibility of Intervention Measure (FIM)
Intervention Appropriateness Measure (AIM)
Secondary outcome measures
Basic Psychological Needs of Participants in Intervention Environment
Blood Pressure of Participants
Cardiovascular Fitness Levels of Participants
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: ControlActive Control1 Intervention
Participants in the control arm will not receive the Hoosier Sport intervention.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
993 Previous Clinical Trials
1,095,249 Total Patients Enrolled
United States Department of Agriculture (USDA)FED
98 Previous Clinical Trials
350,748 Total Patients Enrolled
~23 spots leftby May 2025