- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06486090
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
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:
|
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.
Collaborators
Investigators
- Principal Investigator: Hege Grindem, Oslo Sports Trauma Research Center
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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