We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

FIFA 11 for Health in Europe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03397628
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Health Knowledge, Attitudes, Practice Other: FIFA 11 for health

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.

Currently, there are negotiations with Greenland, Norway, Iceland, Russia and New Zealand to start FIFA 11 for Health pilot projects from August 2017 and also contacts to 10 other countries in Europe and North America to implement the "Danish version" of the programme.

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.

Two scientific articles covering the results of the pilot programme has been published in the spring 2016, showing overall positive effects on health knowledge, well-being and Cardiovascular risk factors such as blood pressure, BMI and % body fat . Another three or four articles, covering the results of the nationwide implementation, are planned to be submitted in the fall 2017, including subgroup analysis based on information about the childrens´ demographic background and socioeconomic status of their parents.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: FIFA 11 for Health in Europe
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 21, 2018
Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
Experimental: Intervention Other: FIFA 11 for health


Outcome Measures

Primary Outcome Measures :
  1. Health Knowledge [ Time Frame: up to 2 yrs ]
    questionnaire


Secondary Outcome Measures :
  1. Fitness [ Time Frame: up to 2 yrs ]
    physical testing

  2. Well-being [ Time Frame: up to 2 yrs ]
    questionnaire

  3. Cognitive function [ Time Frame: up to 2 yrs ]
    Cogstate test battery


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • Disabilities
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397628


Contacts
Contact: Malte Larsen, Msc 004540304689 mnlarsen@health.sdu.dk

Locations
Denmark
University of Southern Denmark Recruiting
Odense, Denmark, 5000
Contact: Malte Larsen, Msc    004540304689    mnlarsen@health.sdu.dk   
Sponsors and Collaborators
University of Southern Denmark
More Information

Responsible Party: Peter Krustrup, Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03397628     History of Changes
Other Study ID Numbers: FIFA11fh
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No