NCT04908930

Brief Summary

Two middle school (ages 11-14) football teams will be in Aim 1 of this study. All interested athletes on these teams will be invited to voluntarily participate in biomechanical data collection; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. In aim 3, two youth football teams at the middle school level will be recruited to pilot an intervention developed this study. The football coaches of each team will be prospectively recruited and enrolled. All interested athletes on these teams will be enrolled; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. Baseline and post-season neurocognitive data will be collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 8, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 27, 2025

Completed
Last Updated

February 27, 2025

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

May 17, 2021

Results QC Date

October 15, 2024

Last Update Submit

February 6, 2025

Conditions

Head InjurySport Injury

Keywords

Sport SafetyYouth FootballHead Impact Exposure

Outcome Measures

Primary Outcomes (10)

  • Number of Head Impacts

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.

    Month 3

  • Number of Impacts Per Player Per Minute

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions. Number of impacts per player per minute

    Month 3

  • Mean Number of Impacts Per Athlete Per Practice

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.

    Month 3

  • 95th Percentile Number of Impacts Per Athlete Per Practice

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) and quantified for practice sessions.

    Month 3

  • Median Linear Acceleration (g)

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median linear acceleration.

    Month 3

  • Median Rotational Acceleration

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational acceleration.

    Month 3

  • Median Rotational Velocity

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of median rotational velocity.

    Month 3

  • 95th Percentile Linear Acceleration (g)

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile linear acceleration.

    Month 3

  • 95th Percentile Rotational Acceleration

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational acceleration.

    Month 3

  • 95th Percentile Rotational Velocity

    Head impact data will be transformed to the head center of gravity using Matlab (Mathworks, Inc., Natick, MA) in terms of 95th percentile rotational velocity.

    Month 3

Secondary Outcomes (51)

  • Feasibility of Intervention Measure (FIM)

    Month 3

  • Acceptability of Intervention Measure (AIM)

    Month 3

  • Percentage of Practices the Intervention Was Implemented as Prescribed

    Month 3

  • Number Changes to the Intervention

    Month 3

  • Verbal Memory (ImPACT) Immediate Post-Concussion Assessment and Cognitive Testing

    Baseline

  • +46 more secondary outcomes

Study Arms (5)

Unexposed practice group- Aim 1

NO INTERVENTION

Data from an unexposed sample (football players practicing as they would otherwise).

On-field activity group - Aim 3

EXPERIMENTAL

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

Behavioral: On-field activity group - Aim 3

Unexposed practice group- Aim 1 Stakeholders

NO INTERVENTION

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.

On-field activity group - Aim 3 Stakeholders

EXPERIMENTAL

coaches pilot tested the COACH program

Behavioral: On-field activity group - Aim 3

Unexposed Practice Group - Other Aim Stakeholders

NO INTERVENTION

Parent and organizational leader stakeholders (unexposed to intervention) participated in guided discussions about safety and biomechanics in youth football

Interventions

On-field activity group - Aim 3BEHAVIORAL

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 3On-field activity group - Aim 3 Stakeholders

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months.

You may not qualify if:

  • Athletes will be excluded from participation if they have had braces less than 6 months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., Herbst Appliance).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • 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.

    PMID: 39351080DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Results Point of Contact

Title
Jillian Urban, PhD
Organization
Wake Forest University Health Sciences
jurban@wakehealth.edu
336.716.0947

Study Officials

  • Jill Urban, PhD, MPH

    Wake Forest Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: All interested football players on the 2 teams will be enrolled; will be randomly selected for instrumentation with head impact sensors using a random numbers table. Athletes on these teams will follow their coach prescribed practice structure. 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

June 1, 2021

Study Start

July 8, 2021

Primary Completion

October 22, 2023

Study Completion

November 29, 2023

Last Updated

February 27, 2025

Results First Posted

February 27, 2025

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Participant Data and Study Protocol

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication
Access Criteria
Individual participant data (IPD) collected in this study be shared using the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system. The National Institute of Health FITBIR database is a data sharing resource for the Traumatic Brain Injury imaging research field. Data sharing forms will be used to upload biomechanical data and associated metadata according to the The National Institute of Neurological Disorders and Stroke Department of Defense (NINDS/DoD) Biomechanical Devices in TBI Common Data Elements (CDE). All data summarized in publications will also be made available upon email request to the study Principal Investigator and upon completion of a data-sharing agreement.

Locations

US(1)