NCT01817049

Brief Summary

Soccer accounts for more than 10% of all sport injuries in youth requiring medical attention. The injury rates in youth soccer where there is no established injury prevention program are estimated at 22-30 injuries/100 participants/year, or 3.4-5.6 injuries/1000 participation hours. Risk reductions ranging from 32-43% have been found for youth players participating in neuromuscular training programs, such as the FIFA 11+, that include agility, balance training, and strengthening components. Although studies have shown that the FIFA 11+ is effective at reducing injuries, there is poor uptake of the program in the youth soccer community. It is therefore important to develop ways of delivering the program to soccer coaches and players in order to maximize its protective benefit. The Health Action Process Approach (HAPA) is a behavior change theory that has been used to successfully predict the uptake of health behaviours in a number of populations, such as cancer screening and exercise, but has not been tested in sport injury prevention settings. The primary objective of this study is to examine the effect of a HAPA-based coach education intervention on adherence to the FIFA 11+ in a group of female youth soccer players over the course of one outdoor and one indoor season. The secondary objective is to examine the dose-response relationship between program adherence and injury, comparing program adherence and injury rates in outdoor and indoor soccer. Our hypothesis is that teams whose coaches receive a HAPA-based intervention will have greater adherence to the program than teams whose coaches do not receive the intervention, and that that injury incidence will decrease as adherence to the program increases. It is expected that program adherence will be lower and injury rates will be higher in indoor soccer compared to outdoor soccer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

March 18, 2013

Last Update Submit

May 28, 2015

Conditions

Keywords

preventionsport injurysocceryouthneuromuscular traininginterventionbehaviour

Outcome Measures

Primary Outcomes (2)

  • Team level adherence

    The number of FIFA 11+ exercises completed by the team and the duration of the session will be recorded for each training session and game during the study seasons.

    duration of two soccer seasons, an expected average of 48 weeks

  • Individual level adherence

    Individual participation in the team training or game session will be recorded, as well as an indication if that player participated in the FIFA 11+ warm up.

    duration of two soccer seasons, an expected average of 48 weeks

Secondary Outcomes (2)

  • Injury

    duration of two soccer seasons, an expected average of 48 weeks

  • Change in HAPA Questionnaire responses from baseline to end of season 1 and season 2

    Change from baseline to end of soccer season 1 (expected duration of 24 weeks) and to end of soccer season 2 (expected duration of 48 weeks)

Other Outcomes (1)

  • Retest reliability of the Sport Concussion Assessment Tool version 3 (SCAT3)

    Reliability from baseline to two weeks

Study Arms (2)

HAPA intervention

EXPERIMENTAL

Coaches will receive a 3.5 hour HAPA-based coach education workshop prior to the start of the first study season.

Behavioral: HAPA-based coach education workshop

Attention control

PLACEBO COMPARATOR

Coaches will receive a 3.5 hour workshop prior to the start of the first study season, consisting of innocuous sport nutrition and sport psychology information as an attention control.

Behavioral: placebo attention control

Interventions

A 3.5 hour workshop will target HAPA constructs by providing injury risk information (risk perceptions), FIFA 11+ effectiveness evidence (outcome expectancies), and hands-on experience administering the 11+ program to a soccer team (task self-efficacy). Action planning and coping planning exercises will also be conducted.

HAPA intervention
Attention control

Eligibility Criteria

Age11 Years - 16 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • or U-16 female soccer team competing in a Calgary Minor Soccer Association league at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season
  • Female youth soccer player (ages 13 to 16 years) participating on a Calgary Minor Soccer Association Club team at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season in a U14 or U16 league

You may not qualify if:

  • Coach who has used the 11+ with a team he/she has previously coached
  • Player with recent (within 6 weeks) history of back or lower extremity injury requiring medical attention or the inability to participate in soccer for at least one day and preventing the player from participating fully at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season
  • Player with a history of systemic disease (e.g. cancer, arthritis, heart disease) or neurological disorder (i.e. head injury, cerebral palsy), preventing the ability to participate fully at the commencement of the 2013 outdoor season and/or the 2013-2014 indoor season and/or the 2014 outdoor season.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport Injury Prevention Research Centre

Calgary, Alberta, T3H 2E1, Canada

Location

Related Publications (1)

  • Steffen K, Meeuwisse WH, Romiti M, Kang J, McKay C, Bizzini M, Dvorak J, Finch C, Myklebust G, Emery CA. Evaluation of how different implementation strategies of an injury prevention programme (FIFA 11+) impact team adherence and injury risk in Canadian female youth football players: a cluster-randomised trial. Br J Sports Med. 2013 May;47(8):480-7. doi: 10.1136/bjsports-2012-091887. Epub 2013 Mar 13.

    PMID: 23486935BACKGROUND

MeSH Terms

Conditions

Behavior

Study Officials

  • Carly McKay, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR
  • Carolyn Emery, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Doctoral Fellow

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 22, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations