NCT06486090

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,954

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

May 9, 2024

Last Update Submit

December 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Weekly injury severity score (0 best - 100 worst)

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

Secondary Outcomes (7)

  • Sudden and gradual onset injuries

    1 sports season (estimated to 32 weeks)

  • Injury location

    1 sports season (estimated to 32 weeks)

  • Injury location for sudden onset injuries

    1 sports season (estimated to 32 weeks)

  • Injury location gradual onset injuries

    1 sports season (estimated to 32 weeks)

  • Injury burden

    1 sports season (estimated to 32 weeks)

  • +2 more secondary outcomes

Other Outcomes (5)

  • Fidelity - workshop completion checklist

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

  • Fidelity - Midseason meeting checklist

    Midseason (about 16 weeks)

  • Dose - completion of e-learning

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

  • +2 more other outcomes

Study Arms (2)

#Utviklingsklar

EXPERIMENTAL

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

Control

NO INTERVENTION

Practice as usual, which may include other injury-preventive coaching practices

Interventions

#UtviklingsklarBEHAVIORAL

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

#Utviklingsklar

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hordaland Fotballkrets

Bergen, Norway

Location

Håndballregion Øst

Oslo, Norway

Location

Oslo Fotballkrets

Oslo, Norway

Location

Akershus Fotballkrets

Strømmen, Norway

Location

Håndballregion Nord

Trondheim, Norway

Location

Trøndelag Fotballkrets

Trondheim, Norway

Location

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Hege Grindem

    Oslo Sports Trauma Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The biostatistician performing the main analysis will be blinded to group assignment
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 9, 2024

First Posted

July 3, 2024

Study Start

May 7, 2024

Primary Completion

November 9, 2025

Study Completion

November 30, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations