Health Knowledge11FHPolandNCT06845059
The "11 for Health" Program Intervention and Its Impact on Polish Children
A study testing "11 For Health" in people with Health Knowledge and Fitness, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Fitness, Wellbeing
- What is being tested?
- "11 For Health"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 663 participants
- Where
- 1 sitePoland
- Study dates
- 14 Feb 2025to 30 Sep 2025
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 9 and 14 years,
- Signed informed consent from a parent or legal guardian for underage participants.
Who cannot join
- Disabilities.
- Medical contraindications.
- Medical or other exemptions from physical education classes.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Wroclaw University of Health and Sport Sciences
Wroclaw, Lower Silesian Voivodeship, 53-633
About this study
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
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
Read the 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.
- Conditions
- Health Knowledge, Fitness, Wellbeing, Health Behavior, Attitude
- Being tested
- "11 For Health"
- Keywords
- FIFA 11 For Health
- Medical subject headings
- Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"11 For Health"Other
Participants will participate in the "11 For Health" program, consisting of 11 sessions over 11 weeks. The program combines football skills with health education to promote overall health and well-being.
| Study group | Role | What they receive |
|---|---|---|
| Standard Physical Education (Control group) | No intervention | Participants will participate in standard physical education (PE) classes with no additional interventions. |
| "11 For Health" Program (Intervention group) | Experimental | Not described Receives: Other: "11 For Health" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Knowledge
Health knowledge will be assessed using the "11 For Health" Health Knowledge Questionnaire. This questionnaire evaluates children's understanding of key health topics, including nutrition, physical activity, and hygiene. It consists of multiple-choice questions, aimed at measuring the knowledge acquired during the program. Higher scores indicate greater health knowledge (min= 0, max= 36)
Measured: Baseline and after 3 months (post-intervention)
Wellbeing
Wellbeing will be assessed using the Kidscreen-27 questionnaire, which evaluates emotional well-being, social functioning, and general life satisfaction. It uses a Likert scale to assess happiness, relationships with family, and feelings of self-worth, capturing the child's overall perception of their quality of life. Higher scores indicate better well-being. Higher scores indicate better well-being (Minimum = 27, Maximum = 135).
Measured: Baseline and after 3 months (post-intervention)
Yo-Yo Intermittent Recovery Test Level 1 (YYIR1C)
Aerobic fitness and endurance will be assessed using the Yo-Yo Intermittent Recovery Test Level 1 (YYIR1C), which measures the total distance covered in a repeated sprint and recovery format. A greater distance (meters [m]) indicates better aerobic capacity.
Measured: Baseline and after 3 months (post-intervention)
Stork Balance Test
Balance performance will be assessed using the Stork Balance Test, which evaluates single-leg balance ability. Time held in seconds ( higher scores indicate better balance).
Measured: Baseline and after 3 months (post-intervention)
Standing Long Jump Test
Lower body explosive strength will be assessed using the Standing Long Jump Test, measuring the horizontal distance jumped from a standing position with hands positioned on hips. A longer (centimeters [cm]) jump indicates better lower-body power
Measured: Baseline and after 3 months (post-intervention)
Hand Grip Test
Muscular strength will be assessed using the Hand Grip Test, which measures maximal isometric grip strength. Measured in kilograms [kg] (higher values = greater grip strength).
Measured: Baseline and after 3 months (post-intervention)
Plank Test
Core endurance will be assessed using the Plank Test, measuring the duration a participant can hold a plank position. A longer (seconds [s]) duration indicates better core endurance.
Measured: Baseline and after 3 months (post-intervention)
20m Sprint Test
Speed and acceleration will be assessed using the 20m Sprint Test, measuring the time taken to cover a 20-meter distance. A shorter time (seconds [s]) indicates better sprint performance.
Measured: Baseline and after 3 months (post-intervention)
Resting Heart Rate
Cardiovascular health will also be assessed by measuring resting heart rate (HR) using an electronic heart rate monitor. Lower resting heart rate (Beats per minute [bpm]) generally indicates better cardiovascular fitness.
Measured: Baseline and after 3 months (post-intervention)
Systolic Blood Pressure
Cardiovascular health will be assessed by measuring resting systolic blood pressure using an electronic blood pressure monitor. Lower values (Millimeters of mercury [mmHg]) within a normal range indicate better cardiovascular health.
Measured: Baseline and after 3 months (post-intervention)
Diastolic blood pressure
Cardiovascular health will be assessed by measuring resting diastolic blood pressure using an electronic blood pressure monitor. Lower values (millimeters of mercury [mmHg]) within a normal range indicate better cardiovascular health.
Measured: Baseline and after 3 months (post-intervention)
Body Fat Percentage
Body fat percentage will be assessed using an electronic bioimpedance tool (InBody 270) to determine the proportion of body weight composed of fat. Lower values (percentage [%]) within a healthy range indicate better body composition.
Measured: Baseline and after 3 months (post-intervention)
Skeletal Muscle Mass
Skeletal muscle mass will be assessed using an electronic bioimpedance tool (InBody 270) to measure the total mass of skeletal muscles in the body. Higher values (kilograms [kg]) indicate greater muscle mass.
Measured: Baseline and after 3 months (post-intervention)
Secondary outcomes (5)
Dietary habits
Dietary habits will be evaluated using the SF-FFQ4PolishChildren questionnaire. This tool assesses food frequency and dietary choices in children, including the types of foods consumed, frequency of consumption, and general eating habits. Higher scores indicate more frequent consumption of a given food group. The questionnaire assesses dietary quality based on eating habits and food intake frequency.
Measured: Baseline and after 3 months (post-intervention)
Physical activity
Physical activity levels will be assessed using the Modified PAQ-C ( Modified Physical Activity Questionnaire for Children). This questionnaire gathers information on the frequency and intensity of physical activities, including sports, outdoor play, and other forms of exercise. Higher scores indicate greater levels of physical activity.
Measured: Baseline and after 3 months (post-intervention)
Programme enjoyment
The enjoyment of the "11 For Health" program and football in general will be assessed through questions like "How did you like the '11 For Health' program?" and "How fun do you think football is?" Responses will be recorded on a 5-point Likert scale to measure the child's (intervention group) enjoyment and overall satisfaction with the program. Higher scores (points, [min=2, max=10]) indicate higher enjoyment level.
Measured: After 3 months (post-intervention)
Body height (BH)
Body height will be measured from the base to the vertex (top of the head) using a stadiometer to provide accurate data on the child's growth and development.
Measured: Baseline and after 3 months (post-intervention)
Body weight (BW)
Body weight will be measured using an electronic scale (InBody), providing precise data on body weight. This method is commonly used in clinical and research settings.
Measured: Baseline and after 3 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start14 Feb 2025
- Primary completion1 Apr 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health KnowledgeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Adrian Drożdżowski, Wroclaw University of Health and Sport Sciences
- Investigators
- Paweł Chmura, Professor, Study director, Wroclaw University of Health and Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845059
- Sponsor's protocol ID
- WroclawUHSS Ethics (21/2024)
- Acronym
- 11FHPoland
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) will only be shared in the form of published scientific articles, which will include anonymized results and analyses. Individual-level data will not be shared directly.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06845059
- Acronym / sponsor ID
- 11FHPoland / WroclawUHSS Ethics (21/2024)
- Conditions
- Health Knowledge, Fitness, Wellbeing, Health Behavior, Attitude
- Keywords
- FIFA 11 For Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 25 Feb 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Physical Education (Control group) | No intervention | –Participants will participate in standard physical education (PE) classes with no additional interventions. |
| "11 For Health" Program (Intervention group) | Experimental | Other: "11 For Health" |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 9 and 14 years,
- Signed informed consent from a parent or legal guardian for underage participants.
Key exclusion criteria (3 listed)
- Disabilities.
- Medical contraindications.
- Medical or other exemptions from physical education classes.
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 |
|---|---|---|
| "11 For Health"Participants will participate in the "11 For Health" program, consisting of 11 sessions over 11 weeks. The program combines football skills with health education to promote overall health and well-being. | Other | "11 For Health" Program (Intervention group) |
Primary outcome
Health Knowledge
Time frame: Baseline and after 3 months (post-intervention)
Health knowledge will be assessed using the "11 For Health" Health Knowledge Questionnaire. This questionnaire evaluates children's understanding of key health topics, including nutrition, physical activity, and hygiene. It consists of multiple-choice questions, aimed at measuring the knowledge acquired during the program. Higher scores indicate greater health knowledge (min= 0, max= 36)
Wellbeing
Time frame: Baseline and after 3 months (post-intervention)
Wellbeing will be assessed using the Kidscreen-27 questionnaire, which evaluates emotional well-being, social functioning, and general life satisfaction. It uses a Likert scale to assess happiness, relationships with family, and feelings of self-worth, capturing the child's overall perception of their quality of life. Higher scores indicate better well-being. Higher scores indicate better well-being (Minimum = 27, Maximum = 135).
Yo-Yo Intermittent Recovery Test Level 1 (YYIR1C)
Time frame: Baseline and after 3 months (post-intervention)
Aerobic fitness and endurance will be assessed using the Yo-Yo Intermittent Recovery Test Level 1 (YYIR1C), which measures the total distance covered in a repeated sprint and recovery format. A greater distance (meters [m]) indicates better aerobic capacity.
Stork Balance Test
Time frame: Baseline and after 3 months (post-intervention)
Balance performance will be assessed using the Stork Balance Test, which evaluates single-leg balance ability. Time held in seconds ( higher scores indicate better balance).
Standing Long Jump Test
Time frame: Baseline and after 3 months (post-intervention)
Lower body explosive strength will be assessed using the Standing Long Jump Test, measuring the horizontal distance jumped from a standing position with hands positioned on hips. A longer (centimeters [cm]) jump indicates better lower-body power
Hand Grip Test
Time frame: Baseline and after 3 months (post-intervention)
Muscular strength will be assessed using the Hand Grip Test, which measures maximal isometric grip strength. Measured in kilograms [kg] (higher values = greater grip strength).
Plank Test
Time frame: Baseline and after 3 months (post-intervention)
Core endurance will be assessed using the Plank Test, measuring the duration a participant can hold a plank position. A longer (seconds [s]) duration indicates better core endurance.
20m Sprint Test
Time frame: Baseline and after 3 months (post-intervention)
Speed and acceleration will be assessed using the 20m Sprint Test, measuring the time taken to cover a 20-meter distance. A shorter time (seconds [s]) indicates better sprint performance.
Resting Heart Rate
Time frame: Baseline and after 3 months (post-intervention)
Cardiovascular health will also be assessed by measuring resting heart rate (HR) using an electronic heart rate monitor. Lower resting heart rate (Beats per minute [bpm]) generally indicates better cardiovascular fitness.
Systolic Blood Pressure
Time frame: Baseline and after 3 months (post-intervention)
Cardiovascular health will be assessed by measuring resting systolic blood pressure using an electronic blood pressure monitor. Lower values (Millimeters of mercury [mmHg]) within a normal range indicate better cardiovascular health.
Diastolic blood pressure
Time frame: Baseline and after 3 months (post-intervention)
Cardiovascular health will be assessed by measuring resting diastolic blood pressure using an electronic blood pressure monitor. Lower values (millimeters of mercury [mmHg]) within a normal range indicate better cardiovascular health.
Body Fat Percentage
Time frame: Baseline and after 3 months (post-intervention)
Body fat percentage will be assessed using an electronic bioimpedance tool (InBody 270) to determine the proportion of body weight composed of fat. Lower values (percentage [%]) within a healthy range indicate better body composition.
Skeletal Muscle Mass
Time frame: Baseline and after 3 months (post-intervention)
Skeletal muscle mass will be assessed using an electronic bioimpedance tool (InBody 270) to measure the total mass of skeletal muscles in the body. Higher values (kilograms [kg]) indicate greater muscle mass.
5 secondary outcomes
Dietary habits
Time frame: Baseline and after 3 months (post-intervention)
Physical activity
Time frame: Baseline and after 3 months (post-intervention)
Programme enjoyment
Time frame: After 3 months (post-intervention)
Body height (BH)
Time frame: Baseline and after 3 months (post-intervention)
Body weight (BW)
Time frame: Baseline and after 3 months (post-intervention)
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 8 Jun 2026.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) will only be shared in the form of published scientific articles, which will include anonymized results and analyses. Individual-level data will not be shared directly.
Related trials for Health Knowledge
Active, not recruiting
Flipped Classroom vs. Flip-Jigsaw in Theoretical Physiotherapy Education
Physiotherapy and Rehabilitation, Educational Technology
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
Active, not recruitingPhase 3
PREVENT HPV -Related Cancers Trial
HPV Vaccination, Uptake Vaccination
Not yet recruiting
The Effect of Health Belief Model-Based HPV Infection and Vaccination Education on University Students' Knowledge and Health Beliefs
Health Belief Model, Nursing Students
Not yet recruiting
Health Care Professionals Diet App Study
Nutrition Education
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.
Paweł Chmura, Professor study director
Wroclaw University of Health and Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "11 For Health" in people with Health Knowledge and Fitness, run by Wroclaw University of Health and Sport Sciences at 1 site in Poland.
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 2 inclusion and 3 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 8 Jun 2026. 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 Poland. 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: Baseline and after 3 months (post-intervention)). The study lists 13 primary outcomes in all. 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 8 Jun 2026.