Clinical Trials Directory

Trials / Completed

CompletedNCT04908930

Evidence-based Intervention for Improved Head Impact Safety in Youth Football - Aim 1 and Aim 3

Community-Engaged Sport Safety - Aim 1 and Aim 3

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
106 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
11 Years – 14 Years
Healthy volunteers
Accepted

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.

Detailed description

This study hypothesizes that (a) determinants at the individual (athlete), interpersonal (team \& coach), and community levels (built \& social environment) of the social ecological model may be identified and targeted to reduce head impact exposure in youth football practices, and (b) an evidence-based strategy to reduce head impact exposure in practices may be developed and pilot tested using a community-engaged approach.

Conditions

Interventions

TypeNameDescription
BEHAVIORALOn-field activity group - Aim 3Athletes 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

Timeline

Start date
2021-07-08
Primary completion
2023-10-22
Completion
2023-11-29
First posted
2021-06-01
Last updated
2025-02-27
Results posted
2025-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04908930. Inclusion in this directory is not an endorsement.