Sport InjuryNCT01817049
The Effect of a Behavioural Intervention on Injury Prevention Program Adherence in Female Youth Soccer
A study testing HAPA-based coach education workshop in people with Sport Injury, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 years, women only
- Conditions the study is for
- Sport Injury
- What is being tested?
- HAPA-based coach education workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 14 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of a Behavioural-based Intervention on Injury Prevention Program Adherence in Canadian Female Youth Soccer Players
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.
Read the detailed description
The first wave of 16 teams will be recruited in spring 2013, and will be followed through the 2013 outdoor season, followed by the 2013-2014 indoor season. The second wave of 16 teams will be recruited in fall 2013, and will be followed through the 2013-2014 indoor season, followed by the 2014 outdoor season.
- Conditions
- Sport Injury
- Being tested
- HAPA-based coach education workshop, placebo attention control
- Keywords
- prevention, sport injury, soccer, youth, neuromuscular training, intervention, behaviour
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAPA-based coach education workshopBehavioural
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.
placebo attention controlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| HAPA intervention | Experimental | Coaches will receive a 3.5 hour HAPA-based coach education workshop prior to the start of the first study season. Receives: 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. Receives: Behavioral: placebo attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: duration of two soccer seasons, an expected average of 48 weeks
Secondary outcomes (2)
Injury
An injury sustained during soccer participation will be recorded. Injury is defined as "any injury occurring during soccer activity resulting in medical attention and/or the removal of the player from the current session and/or subsequent time loss of at least one soccer session (game or practice) as a direct result of that injury."
Measured: 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
A questionnaire will be used to assess changes in HAPA constructs (ie: outcome expectancies, risk perceptions, and self-efficacy) between baseline and the end of each playing season (ie: outdoor and indoor).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sport InjuryStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Carly McKay, University of Calgary
- Investigators
- Carly McKay, PhD, Principal investigator, University of CalgaryCarolyn Emery, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817049
- Sponsor's protocol ID
- STAIRC&Y-mar2013
- Status last verified
- May 2015
- First submitted
- 18 Mar 2013
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23486935
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of a Behavioural-based Intervention on Injury Prevention Program Adherence in Canadian Female Youth Soccer Players
- ClinicalTrials.gov ID
- NCT01817049
- Acronym / sponsor ID
- STAIRC&Y-mar2013
- Conditions
- Sport Injury
- Keywords
- prevention, sport injury, soccer, youth, neuromuscular training, intervention, behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The first wave of 16 teams will be recruited in spring 2013, and will be followed through the 2013 outdoor season, followed by the 2013-2014 indoor season. The second wave of 16 teams will be recruited in fall 2013, and will be followed through the 2013-2014 indoor season, followed by the 2014 outdoor season.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAPA intervention | Experimental | Behavioral: HAPA-based coach education workshopCoaches will receive a 3.5 hour HAPA-based coach education workshop prior to the start of the first study season. |
| Attention control | Placebo comparator | Behavioral: placebo attention controlCoaches 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. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 14 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAPA-based coach education workshopA 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. | Behavioural | HAPA intervention |
| placebo attention control | Behavioural | Attention control |
Primary outcome
Team level adherence
Time frame: duration of two soccer seasons, an expected average of 48 weeks
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.
Individual level adherence
Time frame: duration of two soccer seasons, an expected average of 48 weeks
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.
2 secondary outcomes
Injury
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Background: PubMed 23486935Steffen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carly McKay, PhD principal investigator
University of Calgary
Carolyn Emery, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HAPA-based coach education workshop in people with Sport Injury, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Team level adherence (time frame: duration of two soccer seasons, an expected average of 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.