CVDNCT06556719
Hoosier Sport Re-Social: A Biobehavioral Intervention in Rural Indiana
A study testing Hoosier Sport Re-Social in people with CVD and Sedentary Behavior, run by Indiana University at 2 sites in United States.
Trial summary
Hoosier Sport Re-Social is a sport-based intervention designed to increase physical activity (PA) and reduce social media use among children in under-resourced rural areas, aiming to mitigate cardiovascular disease (CVD) risk. Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- CVD, Sedentary Behavior
- What is being tested?
- Hoosier Sport Re-Social
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Feb 2025to 31 Mar 2025
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- enrolled in 7th-9th grade
- provides parental consent
- provides assent
Who cannot join
- Inability to attend school regularly during the 6-week intervention period
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University
Bloomington, Indiana, 47405
White River Valley Middle School
Lyons, Indiana, 47443
About this study
Hoosier Sport Re-Social is a sport-based intervention designed to increase physical activity (PA) and reduce social media use among children in under-resourced rural areas, aiming to mitigate cardiovascular disease (CVD) risk. The intervention integrates physical activity with social media literacy (SML) training, addressing the dual challenges of low PA levels and high social media usage, which are prevalent in rural communities.
Read the detailed description
Hoosier Sport Re-Social is a comprehensive, sport-based intervention designed to address the dual challenges of low physical activity (PA) and high social media use among children in under-resourced rural areas. This innovative program aims to reduce cardiovascular disease (CVD) risk by promoting healthier behaviors through the integration of physical activity and social media literacy (SML) training. Recognizing that CVD is a leading cause of death, particularly in under-resourced populations, and that fewer than one in five U.S. children meet the recommended PA levels-especially in rural areas-this intervention targets a significant public health need.
The program is designed to be implemented within the school setting, leveraging both physical education (PE) and health classes to deliver its core components. The PA portion of the intervention takes place during PE classes, where students engage in structured sport activities aimed at increasing daily physical activity levels. This component is designed to enhance students' fitness, build confidence in their physical abilities, and foster a lifelong interest in staying active.
Complementing the physical activity focus, the SML portion is integrated into health classes. Here, students are educated about the impacts of social media on health, particularly its role in influencing behavior and well-being. The curriculum equips students with the knowledge and skills to critically analyze social media content, make informed decisions about their digital consumption, and develop healthier online habits.
- Conditions
- CVD, Sedentary Behavior
- Being tested
- Hoosier Sport Re-Social
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hoosier Sport Re-SocialBehavioural
Hoosier Sport Re-Social is a 6-week school-based intervention designed to reduce cardiovascular disease risk in rural children. It includes twice-weekly physical activity sessions during PE classes and weekly social media literacy training in health classes, promoting healthier physical and digital behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Hoosier Sport Re-Social Participants | Experimental | Arm will receive 6-weeks of intervention, including enhanced PE and health class curriculum Receives: Behavioral: Hoosier Sport Re-Social |
| Regular Health and PE Participants | No intervention | Arm will receive regular PE and health class curriculum |
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 6
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 6
Intervention Appropriateness Measure (AIM)
How appropriate the intervention is to the participants. This is measured through questionnaire.
Measured: Measured at week 0 and week 6
Secondary outcomes (13)
Daily Total Physical Activity of Participants
Accelerometers (Axivity - AX3 model) will be used to track total daily physical activity
Measured: Week 1 (for 7 days), and week 6 (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 6 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 6 before and following the 6-minute walk test.
Basic Psychological Needs of Participants in Intervention Environment
Basic Psychological Needs and Satisfaction and Frustration scale. This entails feelings/perceptions of autonomy, relatedness, competence, enjoyment, satisfaction, and frustration in the study setting. Higher scores indicate greater satisfaction.
Measured: Assessed at week 0 and week 6
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 6
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 6
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 6
Daily screen time
data from participants' phone settings will be used to capture daily screen time. Participants will navigate to their screen time settings, where a comprehensive and objective report of their weekly screen time (including average daily screen time) is available. Here, participants will screenshot this data and airdrop it to a secured IU dropbox location.
Measured: Assessed at week 0 and week 6
Daily social media usage
data from participants' phone settings will be used to capture daily screen time. Participants will navigate to their screen time settings, where a comprehensive and objective report of their weekly screen time (including average daily social media usage) is available. Here, participants will screenshot this data and airdrop it to a secured IU dropbox location.
Measured: Assessed at week 0 and week 6
Social media addiction
participants will complete the Bergen Social Media Addiction Scale to assess social media addiction.
Measured: Assessed at week 0 and week 6
Inhibitory control
The Color-Word trial from the Stroop Color and Word Test will be delivered on an iPad/tablet to participants to measure inhibitory control.
Measured: Assessed at week 0 and week 6
Body Satisfaction
The Body Satisfaction Questionnaire (BSQ) will be completed to assess participants satisfaction of their body shape.
Measured: Assessed at week 0 and week 6
Body Appreciation
The Body Appreciation Scale (version 2) (BAS-2) will be completed to assess participants' appreciation of their bodies.
Measured: Assessed at week 0 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start24 Feb 2025
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CVDStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle A. Kercher, Indiana University
- Investigators
- Kyle Kercher, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556719
- Sponsor's protocol ID
- 21473
- Status last verified
- May 2025
- First submitted
- 13 Aug 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Watkins JM, Goss JM, Kercher VMM, Coble CJ, Werner NE, Weaver RG, Kercher KA. Hoosier Sport Re-Social: a protocol for developing a biopsychosocial body satisfaction intervention in rural Indiana. Pilot Feasibility Stud. 2025 Aug 25;11(1):113. doi: 10.1186/s40814-025-01695-5.
PubMed 40855334
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hoosier Sport Re-Social: A Biobehavioral Intervention in Rural Indiana
- ClinicalTrials.gov ID
- NCT06556719
- Acronym / sponsor ID
- 21473
- Conditions
- CVD, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 16 Aug 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.
Hoosier Sport Re-Social is a sport-based intervention designed to increase physical activity (PA) and reduce social media use among children in under-resourced rural areas, aiming to mitigate cardiovascular disease (CVD) risk. The intervention integrates physical activity with social media literacy (SML) training, addressing the dual challenges of low PA levels and high social media usage, which are prevalent in rural communities.
Detailed description
Hoosier Sport Re-Social is a comprehensive, sport-based intervention designed to address the dual challenges of low physical activity (PA) and high social media use among children in under-resourced rural areas. This innovative program aims to reduce cardiovascular disease (CVD) risk by promoting healthier behaviors through the integration of physical activity and social media literacy (SML) training. Recognizing that CVD is a leading cause of death, particularly in under-resourced populations, and that fewer than one in five U.S. children meet the recommended PA levels-especially in rural areas-this intervention targets a significant public health need.
The program is designed to be implemented within the school setting, leveraging both physical education (PE) and health classes to deliver its core components. The PA portion of the intervention takes place during PE classes, where students engage in structured sport activities aimed at increasing daily physical activity levels. This component is designed to enhance students' fitness, build confidence in their physical abilities, and foster a lifelong interest in staying active.
Complementing the physical activity focus, the SML portion is integrated into health classes. Here, students are educated about the impacts of social media on health, particularly its role in influencing behavior and well-being. The curriculum equips students with the knowledge and skills to critically analyze social media content, make informed decisions about their digital consumption, and develop healthier online habits.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hoosier Sport Re-Social Participants | Experimental | Behavioral: Hoosier Sport Re-SocialArm will receive 6-weeks of intervention, including enhanced PE and health class curriculum |
| Regular Health and PE Participants | No intervention | –Arm will receive regular PE and health class curriculum |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- enrolled in 7th-9th grade
- provides parental consent
- provides assent
Key exclusion criteria (1 listed)
- Inability to attend school regularly during the 6-week intervention period
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 Sport Re-SocialHoosier Sport Re-Social is a 6-week school-based intervention designed to reduce cardiovascular disease risk in rural children. It includes twice-weekly physical activity sessions during PE classes and weekly social media literacy training in health classes, promoting healthier physical and digital behaviors. | Behavioural | Hoosier Sport Re-Social Participants |
Primary outcome
Feasibility of Intervention Measure (FIM)
Time frame: Measured at week 0 and week 6
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 6
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 6
How appropriate the intervention is to the participants. This is measured through questionnaire.
13 secondary outcomes
Daily Total Physical Activity of Participants
Time frame: Week 1 (for 7 days), and week 6 (for 7 days)
Heart Rate of Participants
Time frame: HR will be taken at week 0 and week 6 before and following the 6-minute walk test.
Blood Pressure of Participants
Time frame: BP will be taken at week 0 and week 6 before and following the 6-minute walk test.
Basic Psychological Needs of Participants in Intervention Environment
Time frame: Assessed at week 0 and week 6
Physical Literacy of Participants
Time frame: Assessed at week 0 and week 6
Cardiovascular Fitness Levels of Participants
Time frame: Assessed at week 0 and week 6
Muscular Endurance Levels of Participants
Time frame: Assessed at week 0 and week 6
Daily screen time
Time frame: Assessed at week 0 and week 6
Daily social media usage
Time frame: Assessed at week 0 and week 6
Social media addiction
Time frame: Assessed at week 0 and week 6
Inhibitory control
Time frame: Assessed at week 0 and week 6
Body Satisfaction
Time frame: Assessed at week 0 and week 6
Body Appreciation
Time frame: Assessed at week 0 and week 6
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 6 May 2025.
- Derived from this study: PubMed 40855334Watkins JM, Goss JM, Kercher VMM, Coble CJ, Werner NE, Weaver RG, Kercher KA. Hoosier Sport Re-Social: a protocol for developing a biopsychosocial body satisfaction intervention in rural Indiana. Pilot Feasibility Stud. 2025 Aug 25;11(1):113. doi: 10.1186/s40814-025-01695-5.
- Individual participant dataSharing planned: No
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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.
Kyle Kercher, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hoosier Sport Re-Social in people with CVD and Sedentary Behavior, run by Indiana University at 2 sites 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 3 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 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 6). 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?
On the ClinicalTrials.gov record for NCT06556719, which also lists 1 linked publication.
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 6 May 2025.