System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting

NCT04856241 on ClinicalTrials.gov

Making Football Safer for Women: Implementing an Injury Prevention Program

Official title: Prep-to-Play: Comparing the Impact of Supported and Unsupported Implementation Strategies on the Use of an Injury Prevention Program in Women's/Girl's Community Football

  • Sponsor: La Trobe University
  • Enrollment: 2600 (Estimated)
  • Study start: 2021-04-22 (Actual)
  • Primary completion: 2025-04-13 (Estimated)
  • Study completion: 2025-12-21 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Crossover
  • InterventionModelDescription: Stepped-wedge randomised controlled trial. Prior to study initiation, the leagues will be randomly allocated to one of the five wedges for time of crossover from the control to the intervention phase using a computer-generated list of random numbers provided by a statistician. The randomisation sequence will be concealed to the coaches until shortly before the switch (\~four weeks to allow time to organise their workshop).
  • Masking: Single (Outcomes Assessor)
  • PrimaryPurpose: Prevention

Brief Summary

The aim of this study is to determine how we can best support coaches to implement an injury prevention (IP) program (Prep-to-Play) in female community Australian Football. We will recruit at least 140 female community football teams from 15 different football leagues in Victoria, Australia. Teams will be competing in U16, U17, U18, U19 or open womens competitions. We will train and support coaches to implement the IP program and evaluate the effects of the IP program on injuries across two football seasons.

Conditions

  • Anterior Cruciate Ligament Injuries
  • Concussion, Brain
  • Musculoskeletal Injury

Intervention / Treatment

  • Other: Coaching
  • Other: Peer support
  • Other: Educational materials

Primary Outcome Measures

  • Use of Prep-to-Play (Primary outcome) (18 months)
    Use of Prep-to-Play will be calculated as the proportion of all possible team sessions (training and games) where Prep-to-Play essential components were completed. The primary outcome assessor will be the Team Designate (i.e., nominated team manager, or team representative) who will record (via the Smartabase App or website) whether essential components of Prep-to-Play were completed at each training session and games. In addition to the Team Designate, Prep-to-Play Observers (research assistants blinded to randomisation) will make five random visits (≥one prior to the intervention period and ≥two after the intervention period) to observe the execution of Prep-to-Play in order to validate team use data from the Team Designates.

Countries

Australia

Locations and Investigators

  • Community Australian Football Leagues, Melbourne, Australia (Recruiting)
    • Brooke Patterson

Study Officials