Clinical trial NCT06486090: Effectiveness and Process Evaluation of the Injury-preventive Program #Utviklingsklar
Official title: Effectiveness and Process Evaluation of the Injury-preventive Program #Utviklingsklar
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sports Injury
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: University of Bath
name: The Norwegian Olympic and Paralympic Committee and Confederation of Sports
name: The Norwegian Football Federation
name: The Norwegian Handball Federation
First posted: 2024-07-03
Enrollment: 4256
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Oslo Sports Trauma Research Center Questionnaire on Health Problems (OSTRC-H2)
timeFrame: Average of biweekly reports over 1 sports season (estimated to 32 weeks)
Secondary outcomes:
measure: Injury type (acute or overuse)
timeFrame: 1 sports season (estimated to 32 weeks)
measure: Injury burden
timeFrame: 1 sports season (estimated to 32 weeks)
measure: Injury location
timeFrame: 1 sports season (estimated to 32 weeks)
measure: Time from injury to return to full sports participation
timeFrame: 1 sports season (estimated to 32 weeks)
measure: Recurrent injury
timeFrame: 1 sports season (estimated to 32 weeks)
measure: Sports Injury Preventive Behavior Questionnaire (construct scores 0 worst - 1 best)
timeFrame: Baseline, post workshop, midseason (about 16 weeks) and post season (about 32 weeks)
measure: Injury-preventive coaching practices questionnaire
timeFrame: Baseline and post season (about 32 weeks)
Other outcomes:
measure: Fidelity - use of e-learning resources questionnaire
timeFrame: End of season (about 32 weeks)
measure: Fidelity - workshop completion checklist
timeFrame: At workshop (about 1-2 weeks before sports season)
measure: Fidelity - Midseason meeting checklist
timeFrame: Midseason (about 16 weeks)
measure: Dose - completion of e-learning checklist
timeFrame: Before workshop (about 1-2 weeks before sports season)
measure: Dose - workshop attendance checklist
timeFrame: At workshop (about 1-2 weeks before sports season)
measure: Dose - Midseason meeting checklist
timeFrame: Midseason (about 16 weeks)
measure: Adaptation - Spilleklarreglene questionnaire
timeFrame: At workshop (about 1-2 weeks before sports season)
measure: Adaptation - Midseason meeting checklist
timeFrame: Midseason (about 16 weeks)
Locations:
city: Bergen
country: Norway
facility: Hordaland Fotballkrets
city: Oslo
country: Norway
facility: Håndballregion Øst
city: Oslo
country: Norway
facility: Oslo Fotballkrets
city: Trondheim
country: Norway
facility: Håndballregion Nord
city: Trondheim
country: Norway
facility: Trøndelag Fotballkrets
Study officials:
affiliation: Oslo Sports Trauma Research Center
name: Hege Grindem
role: PRINCIPAL_INVESTIGATOR
References: