NCT04481958

Brief Summary

Evidence-based injury prevention training is highly effective in reducing sport-related musculoskeletal injuries in youth. However, this training has so far had limited public health impact because it is not widely or properly implemented or sustained. In this single case study with youth teams from two handball clubs in Southern Sweden, the aim is to test the I-PROTECT model, featuring injury prevention training and an associated implementation plan. The main hypothesis is that the intervention will result in higher motivational and volitional levels in relation to injury prevention training.

Trial Health

57
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Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 27, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

July 8, 2020

Last Update Submit

January 24, 2022

Conditions

Keywords

Physical activityPreventive therapyAdolescentHealth plan implementationBehaviour change

Outcome Measures

Primary Outcomes (1)

  • Health Action Process Approach questions for coaches

    An adapted version of the Health Action Process Approach (HAPA), specifically related to injury prevention training for youth team handball, has been developed and adapted for coaches. The questions focus on motivational strategies (e.g., risk perception, outcome expectancies) and volitional strategies (e.g., action planning, maintenance self-efficacy) for behavior change regarding injury-prevention training.

    Baseline to end-of-season (after approx. 8 months)

Secondary Outcomes (2)

  • Descriptive information about the Covid-19 pandemic and use of I-PROTECT (coaches)

    Baseline to end-of-season (after approx. 8 months)

  • Health Action Process Approach and Reach, Effectiveness, Adoption, Implementation, and Maintenance Sport Setting Matrix questions among caregivers

    Baseline

Study Arms (1)

I-PROTECT model

EXPERIMENTAL

The I-PROTECT model is an end-user-driven intervention including evidence-based, theory-informed, and context-specific injury prevention training for youth handball, and an associated implementation strategy.

Behavioral: I-PROTECT

Interventions

I-PROTECTBEHAVIORAL

The I-PROTECT model is based on existing research and knowledge of experts in sport medicine, sport psychology and implementation science, with the involvement of end-users throughout the process. The interdisciplinary intervention includes exercises based on physical and psychological principles of effective injury prevention training, specifically tailored for youth handball players, and support for developing a continuous implementation strategy. The intervention is delivered through a mobile application (the I-PROTECT GO), including modules tailored for coaches, players, club administrators, and caregivers, respectively. Coaches are introduced to the intervention in a workshop, and they will conduct the exercises with their teams during handball practice. Due to pandemic restrictions, the mobile application could not be finalized, and only the module for coaches was available.

I-PROTECT model

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Players: ages 13-17 years and training ≥2 times/week in a team
  • Coaches: leading ≥1 training session/week
  • Caregivers: directly associated with the eligible players
  • Club administrators: engagement in the issues of sports injury, coach education - or policy development for youth players

You may not qualify if:

  • Employed/paid players

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva Ageberg

Lund, 22100, Sweden

Location

Related Publications (2)

  • Ageberg E, Bunke S, Nilsen P, Donaldson A. Planning injury prevention training for youth handball players: application of the generalisable six-step intervention development process. Inj Prev. 2020 Apr;26(2):164-169. doi: 10.1136/injuryprev-2019-043468. Epub 2020 Feb 4.

    PMID: 32019772BACKGROUND
  • Ageberg E, Bunke S, Lucander K, Nilsen P, Donaldson A. Facilitators to support the implementation of injury prevention training in youth handball: A concept mapping approach. Scand J Med Sci Sports. 2019 Feb;29(2):275-285. doi: 10.1111/sms.13323. Epub 2018 Nov 8.

    PMID: 30339309BACKGROUND

MeSH Terms

Conditions

Athletic InjuriesMotor Activity

Condition Hierarchy (Ancestors)

Wounds and InjuriesBehavior

Study Officials

  • Eva Ageberg, PhD

    Department of Health Sciences, Lund University, Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single case study, purposeful sampling
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Professor

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 22, 2020

Study Start

August 27, 2020

Primary Completion

January 24, 2022

Study Completion

January 24, 2022

Last Updated

February 2, 2022

Record last verified: 2022-01

Locations