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

December 9, 2025 updated by: Hege Grindem, Norwegian School of Sport Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2954

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bergen, Norway
        • Hordaland Fotballkrets
      • Oslo, Norway
        • Håndballregion Øst
      • Oslo, Norway
        • Oslo Fotballkrets
      • Strømmen, Norway
        • Akershus Fotballkrets
      • Trondheim, Norway
        • Håndballregion Nord
      • Trondheim, Norway
        • Trøndelag Fotballkrets

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: #Utviklingsklar
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
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
No Intervention: Control
Practice as usual, which may include other injury-preventive coaching practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Average of biweekly reports over 1 sports season (estimated to 32 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 sports season (estimated to 32 weeks)
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
1 sports season (estimated to 32 weeks)
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
1 sports season (estimated to 32 weeks)
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
1 sports season (estimated to 32 weeks)
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.
1 sports season (estimated to 32 weeks)
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
Baseline, midseason and post season (about 32 weeks)
Injury-preventive coaching practices
Time Frame: Baseline and post season (about 32 weeks)

The injury-preventive coaching practice outcomes consist of:

  1. The change in the extent to which teams complete warm-up as described in the intervention from baseline to end-of season.
  2. The change in the extent to which teams complete strength training as described in the intervention from baseline to end-of season.
  3. The change in the extent to which players with pain or injuries receive guidance on medical care from baseline to end-of season.
  4. 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.
Baseline and post season (about 32 weeks)

Other Outcome Measures

Outcome Measure
Time Frame
Fidelity - workshop completion checklist
Time Frame: At workshop (about 1-2 weeks before sports season)
At workshop (about 1-2 weeks before sports season)
Fidelity - Midseason meeting checklist
Time Frame: Midseason (about 16 weeks)
Midseason (about 16 weeks)
Dose - workshop attendance checklist
Time Frame: At workshop (about 1-2 weeks before sports season)
At workshop (about 1-2 weeks before sports season)
Dose - Midseason meeting checklist
Time Frame: Midseason (about 16 weeks)
Midseason (about 16 weeks)
Dose - completion of e-learning
Time Frame: Before workshop (about 1-2 weeks before sports season)
Before workshop (about 1-2 weeks before sports season)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2024

Primary Completion (Actual)

November 9, 2025

Study Completion (Actual)

November 30, 2025

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 329-130324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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