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

NCT06845059 | Active Not Recruiting

• 1 other identifier: WroclawUHSS Ethics (21/2024)
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Health Knowledge; Fitness; Wellbeing; Health Behavior; Attitude

Keywords

FIFA 11 For Health

Outcome Measures

Primary Outcomes (13)

• 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)

  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).

  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.

  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).

  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

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline and after 3 months (post-intervention)

Secondary Outcomes (5)

• Dietary habits

  Baseline and after 3 months (post-intervention)

• Physical activity

  Baseline and after 3 months (post-intervention)

• Programme enjoyment

  After 3 months (post-intervention)

• Body height (BH)

  Baseline and after 3 months (post-intervention)

• Body weight (BW)

  Baseline and after 3 months (post-intervention)

Study Arms (2)

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"

Interventions

"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.

"11 For Health" Program (Intervention group)

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Wroclaw University of Health and Sport Sciences

Wroclaw, Lower Silesian Voivodeship, 53-633, Poland

Location

MeSH Terms

Conditions

Health Behavior; Behavior

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Paweł Chmura, Professor

  Wroclaw University of Health and Sport Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 25, 2025
• Study Start: February 14, 2025
• Primary Completion: April 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

PL (1)