Clinical trial NCT06845059: The "11 for Health" Program Intervention and Its Impact on Polish Children
Official title: The "11 for Health" Program and Its Impact on Physical Fitness, Health Status, Health Knowledge, and Pro-Health Behaviors of Children in Poland
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Health Knowledge
Fitness
Wellbeing
Health Behavior
Attitude
Keywords: FIFA 11 For Health
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2025-02-25
Enrollment: 400
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the impact of the "11 For Health" program-an innovative football-based health education initiative-on children's physical fitness, health status, health knowledge, and pro-health behaviors. Originally implemented in African and South American countries, the program has been adapted and successfully introduced in European and Asian countries. The intervention consists of structured football sessions integrating health education messages aimed at promoting a healthy lifestyle among schoolchildren. The study aims to evaluate the effectiveness of this program in enhancing both physical fitness and health-related outcomes in comparison to traditional physical education classes

Detailed description: This randomized controlled trial (RCT) will include children from schools that have volunteered to participate in the project. These schools will be assigned to clusters, which will then be randomly allocated to one of two groups: the control group, following the standard physical education curriculum, or the intervention group, participating in the "11 For Health" program over an 11-week period (two sessions per week, 45 minutes each). Within each school, all students in a given cluster will be assigned to the same group to ensure consistency and minimize potential contamination.

Structure of the "11 For Health" Program The "11 For Health" programis a football-based program combined with structured health education content which consists of 11 structured sessions, each lasting 90 minutes and divided into two parts: • "Play Football" - A practical football-based component where children engage in skill-building exercises such as passing, dribbling, and shooting. • "Play Fair" - A theoretical component focused on health education, where key health-related topics (e.g., nutrition, hygiene, physical activity) are introduced through interactive discussions and activities.A new football-related topic paired with an appropriate health message will be discussed each week. Each session follows a standardized manual that outlines learning objectives, football exercises, and health messages. The program is designed to foster both physical engagement and health awareness, reinforcing messages through active participation. Children in the intervention group will participate in the "11 For Health" program during their weekly physical education lessons. In the Polish education system, children typically have 180 minutes of physical education per week. Of this, 90 minutes will be dedicated to the "11 For Health" program, while the remaining time will be spent on the standard physical education curriculum. This will allow for a direct comparison of the impacts of the program against the standard curriculum.

Participants will undergo baseline (pre-test) and post-intervention (post-test) assessments to evaluate physical fitness, health-related knowledge, wellbeing, body composition, health status, and pro-health behaviors. Physical tests and questionnaires will be used to measure outcomes. Physical fitness will be assessed using tests evaluating balance, muscular strength, aerobic capacity, agility, and endurance. Body composition will be analyzed through anthropometric measurements and bioelectrical impedance analysis (BIA), while cardiovascular health will be evaluated by measuring resting heart rate and blood pressure. Health-related knowledge, wellbeing, dietary habits, and physical activity levels will be assessed using questionnaires. Following the intervention, children in the experimental group will report their level of enjoyment of the program and football in general using a 5-point Likert scale. Teachers will complete questionnaires assessing program feasibility, acceptability, and implementation challenges. After the program's completion and data collection, a comparative analysis of the results from both groups will be conducted to determine the impact of the "11 For Health" program in improving physical fitness, health knowledge, health status, overall well-being and pro-health behaviors.

Eligibility criteria: Inclusion Criteria:

* Age between 9 and 14 years,
* Signed informed consent from a parent or legal guardian for underage participants.

Exclusion Criteria:

* Disabilities.
* Medical contraindications.
* Medical or other exemptions from physical education classes.

Primary outcomes:
measure: Health Knowledge
timeFrame: Baseline and after 3 months (post-intervention)
measure: Wellbeing
timeFrame: Baseline and after 3 months (post-intervention)
measure: Yo-Yo Intermittent Recovery Test Level 1 (YYIR1C)
timeFrame: Baseline and after 3 months (post-intervention)
measure: Stork Balance Test
timeFrame: Baseline and after 3 months (post-intervention)
measure: Standing Long Jump Test
timeFrame: Baseline and after 3 months (post-intervention)
measure: Hand Grip Test
timeFrame: Baseline and after 3 months (post-intervention)
measure: Plank Test
timeFrame: Baseline and after 3 months (post-intervention)
measure: 20m Sprint Test
timeFrame: Baseline and after 3 months (post-intervention)
measure: Resting Heart Rate
timeFrame: Baseline and after 3 months (post-intervention)
measure: Systolic Blood Pressure
timeFrame: Baseline and after 3 months (post-intervention)
measure: Diastolic blood pressure
timeFrame: Baseline and after 3 months (post-intervention)
measure: Body Fat Percentage
timeFrame: Baseline and after 3 months (post-intervention)
measure: Skeletal Muscle Mass
timeFrame: Baseline and after 3 months (post-intervention)
Secondary outcomes:
measure: Dietary habits
timeFrame: Baseline and after 3 months (post-intervention)
measure: Physical activity
timeFrame: Baseline and after 3 months (post-intervention)
measure: Programme enjoyment
timeFrame: After 3 months (post-intervention)
measure: Body height (BH)
timeFrame: Baseline and after 3 months (post-intervention)
measure: Body weight (BW)
timeFrame: Baseline and after 3 months (post-intervention)
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw University of Health and Sport Sciences
state: Dolnośląskie
Study officials:
affiliation: Wroclaw University of Health and Sport Sciences
name: Paweł Chmura, Professor
role: STUDY_DIRECTOR
References: