Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3
NCT ID: NCT04908930
Last Updated: 2025-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2021-07-08
2023-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
Two additional youth football teams at the middle school level will be recruited to pilot test the intervention developed in this study. All interested athletes on these teams will be enrolled; will be randomly selected for instrumentation with head impact sensors using a random numbers table.
Enrolled athletes will wear head impact sensors embedded in a custom mouthpiece that will be used to collect head impact exposure in conjunction with on-field video data for the season.
SUPPORTIVE_CARE
NONE
Study Groups
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Unexposed practice group- Aim 1
Data from an unexposed sample (football players practicing as they would otherwise).
No interventions assigned to this group
On-field activity group - Aim 3
Athletes of two new teams at the middle school level to pilot the practice structure intervention and continuously monitor on-field activity with head impact sensors to evaluate the feasibility, acceptability, and sustainability of the practice structure
On-field activity group - Aim 3
Athletes of two new teams at the middle school level to pilot the practice structure intervention and continuously monitor on-field activity with head impact sensors to evaluate the feasibility, acceptability, and sustainability of the practice structure
Unexposed practice group- Aim 1 Stakeholders
Stakeholders (parents, coaches, league officials) participated in guided discussions using an audit and feedback approach (sharing biomechanical data with the stakeholders) and semi-structured focus groups with the coaches and parents of the participating teams. Also, key informant interviews with league officials were used to assess the awareness and receptivity to creating a safer practice structure.
No interventions assigned to this group
On-field activity group - Aim 3 Stakeholders
coaches pilot tested the COACH program
On-field activity group - Aim 3
Athletes of two new teams at the middle school level to pilot the practice structure intervention and continuously monitor on-field activity with head impact sensors to evaluate the feasibility, acceptability, and sustainability of the practice structure
Unexposed Practice Group - Other Aim Stakeholders
Parent and organizational leader stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football
No interventions assigned to this group
Interventions
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On-field activity group - Aim 3
Athletes of two new teams at the middle school level to pilot the practice structure intervention and continuously monitor on-field activity with head impact sensors to evaluate the feasibility, acceptability, and sustainability of the practice structure
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
11 Years
14 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Jill Urban, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Wake Forest Health Sciences
Locations
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Wake Forest Health Sciences
Winston-Salem, North Carolina, United States
Countries
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References
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Urban JE, Moore JB, Marks ME, Holcomb TD, Patterson R, McCoy A, Miles CM, Stitzel JD, Foley KL. Protocol for COACH, an evidence-based intervention for improved head impact safety in youth American football developed using a community-engaged approach. Contemp Clin Trials Commun. 2024 Sep 17;42:101371. doi: 10.1016/j.conctc.2024.101371. eCollection 2024 Dec.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00067187
Identifier Type: -
Identifier Source: org_study_id
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