ClinicalTrials.gg
CompletedNCT03397628Updated Dec 13, 2022

FIFA 11 for Health in Europe

An interventional study of FIFA 11 for health in Health Knowledge, Attitudes, Practice, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 9 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-13.

Sponsored by University of Southern Denmark · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
20,000
Allocation
Randomized
Ages
9 Years to 12 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Health Knowledge, Attitudes, Practice

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03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's enrollment of 20,000 is above the median of 120 across 1,197 interventional studies indexed under Behavior.

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Lead sponsor

University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy

Exclusion criteria

Exclusion Criteria:

  • Disabilities
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
20,000 participants (actual)

Study arms

  • No intervention
    Control
  • Experimental
    Intervention

    Other: FIFA 11 for health

Interventions

  • OtherFIFA 11 for health
06

What researchers measure

Primary outcomes

  1. Health Knowledge

    questionnaire

    Time frame: up to 2 yrs

Secondary outcomes

  1. Fitness

    physical testing

    Time frame: up to 2 yrs

  2. Well-being

    questionnaire

    Time frame: up to 2 yrs

  3. Cognitive function

    Cogstate test battery

    Time frame: up to 2 yrs

07

Study locations

1 site
  • University of Southern Denmark
    Odense, 5000, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2016 to primary completion in Dec 2018, 28 months.

Of 741 non-industry interventional studies with no phase under Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's 28 months is above that.

Counting every sponsor, half of 757 studies reached it within 13 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2016
First posted
Jan 12, 2018
StartActual
Aug 1, 2016
Primary completionActual
Dec 30, 2018
CompletionActual
Dec 30, 2020
Last update
Dec 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03397628
Responsible party
Peter Krustrup (Professor, University of Southern Denmark) — Principal investigator
First posted
Jan 12, 2018
Start date
Aug 1, 2016
Primary completion
Dec 30, 2018
Completion
Dec 30, 2020
Last update
Dec 13, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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