NCT03397628

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

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

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

2.4 years

First QC Date

September 23, 2016

Last Update Submit

December 10, 2022

Conditions

Health Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (1)

  • Health Knowledge

    questionnaire

    up to 2 yrs

Secondary Outcomes (3)

  • Fitness

    up to 2 yrs

  • Well-being

    up to 2 yrs

  • Cognitive function

    up to 2 yrs

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL
Other: FIFA 11 for health

Interventions

FIFA 11 for healthOTHER
Intervention

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy

You may not qualify if:

  • Disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Behavior

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2016

First Posted

January 12, 2018

Study Start

August 1, 2016

Primary Completion

December 30, 2018

Study Completion

December 30, 2020

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)