The "11 for Health" Program Intervention and Its Impact on Polish Children

NCT ID: NCT06845059

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2025-09-30

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.

Conditions

Health Knowledge; Fitness; Wellbeing; Health Behavior; Attitude

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Standard Physical Education (Control group)

Participants will participate in standard physical education (PE) classes with no additional interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

"11 For Health" Program (Intervention group)

Group Type: EXPERIMENTAL

"11 For Health"

Intervention Type: 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.

Interventions

"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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role: lead

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Responsible Party

Adrian Drożdżowski

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paweł Chmura, Professor

Role: STUDY_DIRECTOR

Wroclaw University of Health and Sport Sciences

Locations

Wroclaw University of Health and Sport Sciences

Wroclaw, Lower Silesian Voivodeship, Poland

Countries

Poland

Other Identifiers

WroclawUHSS Ethics (21/2024)

Identifier Type: -

Identifier Source: org_study_id