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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 (for 7 days), and week 9 (for 7 days)

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,127 Total Patients Enrolled

United States Department of Agriculture (USDA)FED

96 Previous Clinical Trials

350,638 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria to participate in this medical research study?

"To qualify for entrance into this research study, individuals must present with cardiovascular illness and be between 9 and 15 years old. The trial has availability for a maximum of 40 participants."

Answered by AI

Is there an age restriction for participants under 25 in this clinical trial?

"This research is seeking participants who are older than 9 years but younger than 15 years."

Answered by AI

Is the enrollment for this research study still ongoing?

"Affirmative. The details on clinicaltrials.gov highlight the ongoing recruitment efforts for this investigation. It was initially shared on 2/20/2024 and most recently revised on 2/19/2024. This trial aims to enroll 40 participants from a single site."

Answered by AI

What is the current number of participants who are being recruited for this research study?

"Indeed, information from clinicaltrials.gov shows that this investigation is currently seeking participants. This study first appeared on 2/20/2024 and was last revised on 2/19/2024. The aim is to recruit 40 individuals from a single site."

Answered by AI

What is the primary objective of this clinical trial endeavor?

"This clinical trial aims to evaluate the Acceptability of Intervention Measure (IAM) within a time frame spanning week 0 and week 9. Secondary assessments include evaluating participants' cardiovascular fitness levels using the 6-minute walk test, monitoring their daily Moderate to Vigorous Physical Activity with Axivity accelerometers (AX3 model), and tracking heart rate measurements via a blood pressure monitor throughout the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kyle A. Kercher 2024. "Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06280859.

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