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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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 |
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.