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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2954

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hege Grindem, PhD
  • Phone Number: +4795106154
  • Email: hegeg@nih.no

Study Locations

  • Norway
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: #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
No Intervention: Control
Practice as usual, which may include other injury-preventive coaching practices

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian School of Sport Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Linkoeping University
University of Bath
The Norwegian Olympic and Paralympic Committee and Confederation of Sports
The Norwegian Football Federation
The Norwegian Handball Federation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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