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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03459313
Other study ID # 2017/520-31
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 18, 2018
Est. completion date February 1, 2019

Study information

Verified date September 2019
Source Linkoeping University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The long-term purpose of an on-going participatory action research program "The KLUB-study" in Sweden, that involves scientists and representatives from all levels of athletics, is to develop a sustainable framework for safe athletics (track and field) training for child athletes born 2002-2006. The first part of the research program, a 1-year longitudinal study analysing training and injury data, was completed in November 2017. The present study sets out to evaluate a website that aims to support coaches and caregivers in their role as adult key stakeholders to foster young athletes to become adult athletes who possess the tools to maintain a healthy sporting lifestyle.


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).


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date February 1, 2019
Est. primary completion date July 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Active group
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.

Locations

Country Name City State
Sweden Swedish Athletics Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Linkoeping University Swedish Athletics Association

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Jacobsson J, Bergin D, Timpka T, Nyce JM, Dahlström Ö. 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. — View Citation

Jacobsson J, Timpka T, Ekberg J, Kowalski J, Nilsson S, Renström 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. — View Citation

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche 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. Review. — View Citation

Timpka T, Alonso JM, Jacobsson J, Junge A, Branco P, Clarsen B, Kowalski J, Mountjoy M, Nilsson S, Pluim B, Renström P, Rønsen 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Injury incidence The primary outcome measure will be time from study entry to the first reported injury event four months
Secondary Health literacy 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
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