Cardiovascular DiseasesNCT06280859
Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana
A study testing Hoosier Sport in people with Cardiovascular Diseases and Sedentary Behavior, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Sedentary Behavior
- What is being tested?
- Hoosier Sport
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2024to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Has PE class the semester during Hoosier Sport-
- Parent provides informed consent
Who cannot join
- Answer yes to any question on the Physical Activity Readiness for Everybody (PARQ+)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cardiovascular Diseases, Sedentary Behavior
- Being tested
- Hoosier Sport
- Medical subject headings
- Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hoosier SportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Hoosier Sport |
| Control | No intervention | Participants in the control arm will not receive the Hoosier Sport intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure (FIM)
How feasible the intervention was from the perspective of the participants. This is measured through questionnaire.
Measured: 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: 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: Measured at week 0 and week 9
Secondary outcomes (11)
Daily Steps of Participants
Accelerometers (Axivity - AX3 model) will be used to track daily steps
Measured: 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
Measured: Week 1 (for 7 days), and week 9 (for 7 days)
Heart Rate of Participants
heart rate measured via a blood pressure monitor
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at week 0 and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Feb 2024
- Primary completion30 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Kyle A. Kercher, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280859
- Sponsor's protocol ID
- 18784
- Status last verified
- Aug 2024
- First submitted
- 11 Feb 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All individual participant data will be masked and only the PI will have access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hoosier Sport: Developing and Implementing a Sustainable Campus-Community Partnership in Rural Indiana
- ClinicalTrials.gov ID
- NCT06280859
- Acronym / sponsor ID
- 18784
- Conditions
- Cardiovascular Diseases, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Hoosier SportParticipants 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. |
| Control | No intervention | –Participants in the control arm will not receive the Hoosier Sport intervention. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Has PE class the semester during Hoosier Sport-
- Parent provides informed consent
Key exclusion criteria (1 listed)
- Answer yes to any question on the Physical Activity Readiness for Everybody (PARQ+)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hoosier SportHoosier 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. | Behavioural | Intervention |
Primary outcome
Feasibility of Intervention Measure (FIM)
Time frame: Measured at week 0 and week 9
How feasible the intervention was from the perspective of the participants. This is measured through questionnaire.
Acceptability of Intervention Measure (IAM)
Time frame: Measured at week 0 and week 9
How acceptable the intervention is to the participants. This is measured through questionnaire.
Intervention Appropriateness Measure (AIM)
Time frame: Measured at week 0 and week 9
How appropriate the intervention is to the participants. This is measured through questionnaire.
11 secondary outcomes
Daily Steps of Participants
Time frame: Week 1 (for 7 days), and week 9 (for 7 days)
Daily Moderate to Vigorous Physical Activity of Participants
Time frame: Week 1 (for 7 days), and week 9 (for 7 days)
Heart Rate of Participants
Time frame: HR will be taken at week 0 and week 9 before and following the 6-minute walk test.
Blood Pressure of Participants
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
Time frame: Assessed at week 0 and week 9
Physical Literacy of Participants
Time frame: Assessed at week 0 and week 9
Cardiovascular Fitness Levels of Participants
Time frame: Assessed at week 0 and week 9
Muscular Endurance Levels of Participants
Time frame: Assessed at week 0 and week 9
Self-Reported Weekly Moderate to Vigorous Physical Activity of Participants
Time frame: Assessed at week 0 and week 9
Nutrition Knowledge of Participants
Time frame: Assessed at week 0 and week 9
Policy, Systems, and Environmental Factors Influencing Participant Physical Activity and Nutrition Behavior.
Time frame: Assessed at week 0 and week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No. All individual participant data will be masked and only the PI will have access to the data.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hoosier Sport in people with Cardiovascular Diseases and Sedentary Behavior, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (FIM) (time frame: Measured at week 0 and week 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.