- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03459313
Prevention of Injuries in Young Athletics (Track and Field) Athletes
Prevention of Injuries in Young Athletics (Track and Field) Athletes: Initiation of Life-long Sports Health Literacy - KLUB§ Athletics
Study Overview
Detailed Description
The intervention will be implemented in youth athletics and evaluated in a randomised controlled trial (RCT). It will follow the consensus guidelines for studies in athletics and be reported according to the CONSORT checklist. The participating clubs will be randomly allocated into active and control group. The active group will be provided the intervention program, i.e. access to a website, aimed to support coaches, caregivers´ and athletes' and improve knowledge and health literacy to make more informed choices that promote health. The control group will continue to train according to their routines and will get access to the website after 4 months.
The participants will be assessed at three times, at the beginning of the study (T1), after four months (T2), at ten months (T3) and additional prospective data on training and injury will be collected during the first four months (T1b).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Stockholm, Sweden
- Swedish Athletics
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- belonging to a sports club and participate in organized training, athletics (track and field)
- born 2002 - 2006
Exclusion Criteria:
- not, on a regular basis, participating in athletics (track and field) training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active group
The active group will be provided the intervention program, i.e. access to a website.
|
For this study, the Frisk.Friidrott (Healthy.Athletics/Track&Field) website has been developed.
The purpose of the website is to provide an easy-to-use tool that can assist coaches and parents involved in youth athletics with information how to structure training and recovery planning, provide guidance on possible injuries, and provide other information on health for youth athletes.
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No Intervention: Control group
The control group will continue to train according to their routines and will get access to the website after 4 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Injury incidence
Time Frame: four months
|
The primary outcome measure will be time from study entry to the first reported injury event
|
four months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health literacy
Time Frame: four and ten months
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Evaluate health literacy using Swedish versions of; The Japanese Communicative and Critical Health literacy scale (adults) and the Health Literacy for School-aged Children (HLSAC) instrument (youth athletes)
|
four and ten months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
- Jacobsson J, Timpka T, Ekberg J, Kowalski J, Nilsson S, Renstrom P. Design of a protocol for large-scale epidemiological studies in individual sports: the Swedish Athletics injury study. Br J Sports Med. 2010 Dec;44(15):1106-11. doi: 10.1136/bjsm.2009.067678. Epub 2010 May 19.
- Timpka T, Alonso JM, Jacobsson J, Junge A, Branco P, Clarsen B, Kowalski J, Mountjoy M, Nilsson S, Pluim B, Renstrom P, Ronsen O, Steffen K, Edouard P. Injury and illness definitions and data collection procedures for use in epidemiological studies in Athletics (track and field): consensus statement. Br J Sports Med. 2014 Apr;48(7):483-90. doi: 10.1136/bjsports-2013-093241.
- Jacobsson J, Bergin D, Timpka T, Nyce JM, Dahlstrom O. Injuries in youth track and field are perceived to have multiple-level causes that call for ecological (holistic-developmental) interventions: A national sporting community perceptions and experiences. Scand J Med Sci Sports. 2018 Jan;28(1):348-355. doi: 10.1111/sms.12929. Epub 2017 Aug 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/520-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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