Health Knowledge, Attitudes, PracticeNCT03397628
FIFA 11 for Health in Europe
A study testing FIFA 11 for health in people with Health Knowledge, Attitudes, Practice, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Proposed action: To investigate the effect of an innovative and easily implementable football-based health education programme on well-being, self-esteem, health knowledge and physical fitness for 10-12-year old school children. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- FIFA 11 for health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2016to 30 Dec 2020
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy
Who cannot join
- Disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Proposed action: To investigate the effect of an innovative and easily implementable football-based health education programme on well-being, self-esteem, health knowledge and physical fitness for 10-12-year old school children. The programme has been running in 22 countries in Africa and South America and is now being adapted to the Western World. The first step was to run a pilot implementation for more than 600 school children in Copenhagen, Frederiksberg, Roskilde and Frederikssund in the school year 2015-2016. From august 2016 to a nationwide implementation for 30,000 school children is started in Denmark and The Faroe Islands.
Read the detailed description
Proposed action: To investigate the effect of an innovative and easily implementable football-based health education programme on well-being, self-esteem, health knowledge and physical fitness for 10-12-year old school children. The programme has been running in 22 countries in Africa and South America and is now being adapted to the Western World. The first step was to run a pilot implementation for more than 600 school children in Copenhagen, Frederiksberg, Roskilde and Frederikssund in the school year 2015-2016. From august 2016 to a nationwide implementation for 30,000 school children is started in Denmark and The Faroe Islands. The programme is developed and implemented in a close collaboration between the University of Southern Denmark, University of Copenhagen, The Danish Football Association and the international football association FIFA, and the ambitious scope of the project is to continue this collaboration in a large-scale implementation involving up to 1 million children in up to 30 Western Countries.
As in Africa and South America FIFA is providing all equipment for the programme, including footballs, cones, bibs, training manuals etc. FIFA and the Danish FA have employed a co-funded national project leader in Denmark for a 3-year period, starting August 2015.
The University of Southern Denmark and the Danish FA is responsible for the training manuals, coaching courses for school teachers and the research related the nationwide implementation.
Main project activities: The FIFA 11 for Health in Denmark programme is being delivered 30,000 school children aged 10-12 (5th grade pupils) in the nationwide implementation phase. The programme is being delivered by two school teachers (one female and one male teacher) in each of the schools, and includes two weekly 45-min sessions per week over an 11-week period. The football-based health education programme incorporates fun, joyful and social small-sided games and pair-exercises along with specific focus on one important health message in week. Girls and boys will play together, and the exercises are conducted so that all the children will have a high involvement, success rate and intensity, also the unfit, obese, and non-sport club active. At the same time the exercises are constructed with special focus on how to be a good friend and a team player, how to demonstrate empathy and skill in helping others both individually and as a group, and how to avoid bullying and how to think positively. The 11 health messages cover the most important and prominent health challenges of the Western World, including importance social wellbeing, mental health, physical activity, diet, hygiene and risk-behavior such as abuse of alcohol and drugs.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- FIFA 11 for health
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIFA 11 for healthOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Other: FIFA 11 for health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Knowledge
questionnaire
Measured: up to 2 yrs
Secondary outcomes (3)
Fitness
physical testing
Measured: up to 2 yrs
Well-being
questionnaire
Measured: up to 2 yrs
Cognitive function
Cogstate test battery
Measured: up to 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start1 Aug 2016
- Primary completion30 Dec 2018
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Krustrup, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397628
- Sponsor's protocol ID
- FIFA11fh
- Status last verified
- Dec 2022
- First submitted
- 23 Sep 2016
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIFA 11 for Health in Europe
- ClinicalTrials.gov ID
- NCT03397628
- Acronym / sponsor ID
- FIFA11fh
- Conditions
- Health Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 12 Jan 2018 (actual)
- 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.
Proposed action: To investigate the effect of an innovative and easily implementable football-based health education programme on well-being, self-esteem, health knowledge and physical fitness for 10-12-year old school children. The programme has been running in 22 countries in Africa and South America and is now being adapted to the Western World. The first step was to run a pilot implementation for more than 600 school children in Copenhagen, Frederiksberg, Roskilde and Frederikssund in the school year 2015-2016. From august 2016 to a nationwide implementation for 30,000 school children is started in Denmark and The Faroe Islands.
Detailed description
Proposed action: To investigate the effect of an innovative and easily implementable football-based health education programme on well-being, self-esteem, health knowledge and physical fitness for 10-12-year old school children. The programme has been running in 22 countries in Africa and South America and is now being adapted to the Western World. The first step was to run a pilot implementation for more than 600 school children in Copenhagen, Frederiksberg, Roskilde and Frederikssund in the school year 2015-2016. From august 2016 to a nationwide implementation for 30,000 school children is started in Denmark and The Faroe Islands. The programme is developed and implemented in a close collaboration between the University of Southern Denmark, University of Copenhagen, The Danish Football Association and the international football association FIFA, and the ambitious scope of the project is to continue this collaboration in a large-scale implementation involving up to 1 million children in up to 30 Western Countries.
As in Africa and South America FIFA is providing all equipment for the programme, including footballs, cones, bibs, training manuals etc. FIFA and the Danish FA have employed a co-funded national project leader in Denmark for a 3-year period, starting August 2015.
The University of Southern Denmark and the Danish FA is responsible for the training manuals, coaching courses for school teachers and the research related the nationwide implementation.
Main project activities: The FIFA 11 for Health in Denmark programme is being delivered 30,000 school children aged 10-12 (5th grade pupils) in the nationwide implementation phase. The programme is being delivered by two school teachers (one female and one male teacher) in each of the schools, and includes two weekly 45-min sessions per week over an 11-week period. The football-based health education programme incorporates fun, joyful and social small-sided games and pair-exercises along with specific focus on one important health message in week. Girls and boys will play together, and the exercises are conducted so that all the children will have a high involvement, success rate and intensity, also the unfit, obese, and non-sport club active. At the same time the exercises are constructed with special focus on how to be a good friend and a team player, how to demonstrate empathy and skill in helping others both individually and as a group, and how to avoid bullying and how to think positively. The 11 health messages cover the most important and prominent health challenges of the Western World, including importance social wellbeing, mental health, physical activity, diet, hygiene and risk-behavior such as abuse of alcohol and drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Other: FIFA 11 for health |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- Disabilities
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 |
|---|---|---|
| FIFA 11 for health | Other | Intervention |
Primary outcome
Health Knowledge
Time frame: up to 2 yrs
questionnaire
3 secondary outcomes
Fitness
Time frame: up to 2 yrs
Well-being
Time frame: up to 2 yrs
Cognitive function
Time frame: up to 2 yrs
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 13 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIFA 11 for health in people with Health Knowledge, Attitudes, Practice, run by University of Southern Denmark at 1 site in Denmark.
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 1 inclusion and 1 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 13 Dec 2022. 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 Denmark. 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. 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?
Health Knowledge (time frame: up to 2 yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2022.