NCT06280859

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

3 months

First QC Date

February 11, 2024

Last Update Submit

August 27, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (11)

  • Daily Steps of Participants

    Week 1 (for 7 days), and week 9 (for 7 days)

  • Daily Moderate to Vigorous Physical Activity of Participants

    Week 1 (for 7 days), and week 9 (for 7 days)

  • Heart Rate of Participants

    HR will be taken at week 0 and week 9 before and following the 6-minute walk test.

  • Blood Pressure of Participants

    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

    Assessed at week 0 and week 9

  • +6 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in the control arm will not receive the Hoosier Sport intervention.

Interventions

Hoosier SportBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Has PE class the semester during Hoosier Sport-
  • Parent provides informed consent

You may not qualify if:

  • Answer yes to any question on the Physical Activity Readiness for Everybody (PARQ+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesSedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Students enrolled in physical education (PE) class will be eligible to enroll in the study, and serve as the intervention group. Those not enrolled in PE that semester will be recruited as the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 11, 2024

First Posted

February 28, 2024

Study Start

February 20, 2024

Primary Completion

May 30, 2024

Study Completion

June 10, 2024

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

All individual participant data will be masked and only the PI will have access to the data.

Locations