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Completed

NCT Number: NCT06486090

Effectiveness and Process Evaluation of the Injury-preventive Program #Utviklingsklar

The majority of injuries among Norwegian youth occur in sports. The purpose of the project is to conduct an effect and process evaluation of the intervention #Utviklingsklar, an injury-preventive club-based intervention in youth handball and football. Central to the evaluation is whether the intervention influences the occurrence of new and recurring injuries through changed coaching practices (injury prevention warm-up, strength training, and management of players with pain and injuries). Over one season, participants from 30 clubs in youth handball and football respectively will participate in two cluster-randomized studies. Coaches and club leaders implement #Utviklingsklar and create plans and practices for injury prevention. The control clubs train as usual. Players report injuries. An additional handball and football club are followed up with observation and interviews in a qualitative part of the process evaluation. The project provides knowledge about how injuries and health in the ¾ of Norwegian youth who participate in organized sports are affected by interventions aimed at club and coaching practices.

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Key information

Age range

12 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hordaland Fotballkrets, Bergen, Norway

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Clubs are eligible for participation if they are able to participate with one club leader, 2-6 teams, and a minimum of one coach from each of the participating teams

Exclusion criteria

  • Players under the age of 12
  • Coaches under the age of 16

Treatment and study plan

#Utviklingsklar

Behavioral

The intervention consists of 1) an e-learning course, 2) a workshop to create plans and practices for injury-prevention, 3) a mid-season meeting

Primary outcomes

  1. Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC-H2)

    Time frame: Average of biweekly reports over 1 sports season (estimated to 32 weeks)

    Weekly injury severity score (0 best - 100 worst)

Secondary outcomes

  1. Sudden and gradual onset injuries

    Time frame: 1 sports season (estimated to 32 weeks)

    Weekly injury severity score during the match season for sudden and gradual onset injuries

  2. Injury location

    Time frame: 1 sports season (estimated to 32 weeks)

    Weekly injury severity score during the match season for lower leg, ankle/foot, knee, shoulder (handball), thigh (football), hip/groin (football), lumbosacral (football) and head (football) injuries

  3. Injury location for sudden onset injuries

    Time frame: 1 sports season (estimated to 32 weeks)

    weekly injury severity score during the match season for sudden onset lower leg, ankle/foot, knee, shoulder (handball), thigh (football), hip/groin (football), and lumbosacral (football) injuries

  4. Injury location gradual onset injuries

    Time frame: 1 sports season (estimated to 32 weeks)

    Weekly injury severity score during the match season for gradual-onset lower leg, ankle/foot, knee, shoulder (handball), thigh (football), hip/groin (football), and lumbosacral (football) injuries

  5. Injury burden

    Time frame: 1 sports season (estimated to 32 weeks)

    Defined as the sum of injury severity score divided by the sum of exposure (per 1000 hours), where the sums are over team and over match season. The unit of analysis for burden is thus team and not player.

  6. Sports Injury Preventive Behavior Questionnaire (construct scores 0 worst - 1 best)

    Time frame: Baseline, midseason and post season (about 32 weeks)

    The aggregated construct scores for the determinants 1) risk perception, 2) intention, 3) outcome expectancies, 4) action self-efficacy, 5) maintenance self-efficacy, 6) coping self-efficacy, 7) recovery self-efficacy, 8) action plans 9) coping plans and 10) club social support

  7. Injury-preventive coaching practices

    Time frame: Baseline and post season (about 32 weeks)

    The injury-preventive coaching practice outcomes consist of:

    • The change in the extent to which teams complete warm-up as described in the intervention from baseline to end-of season.
    • The change in the extent to which teams complete strength training as described in the intervention from baseline to end-of season.
    • The change in the extent to which players with pain or injuries receive guidance on medical care from baseline to end-of season.
    • The change in the extent to which training and match participation is facilitated for players with pain or injuries from baseline to end-of season.

Other outcomes

  1. Fidelity - workshop completion checklist

    Time frame: At workshop (about 1-2 weeks before sports season)

  2. Fidelity - Midseason meeting checklist

    Time frame: Midseason (about 16 weeks)

  3. Dose - completion of e-learning

    Time frame: Before workshop (about 1-2 weeks before sports season)

  4. Dose - workshop attendance checklist

    Time frame: At workshop (about 1-2 weeks before sports season)

  5. Dose - Midseason meeting checklist

    Time frame: Midseason (about 16 weeks)

Sponsors and collaborators

Lead sponsor

Norwegian School of Sport Sciences

Other

Collaborators

  • Linkoeping University
  • The Norwegian Football Federation
  • The Norwegian Handball Federation
  • The Norwegian Olympic and Paralympic Committee and Confederation of Sports
  • University of Bath

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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