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临床试验/NCT06845059
NCT06845059已完成不适用

The "11 for Health" Program and Its Impact on Physical Fitness, Health Status, Health Knowledge, and Pro-Health Behaviors of Children in Poland

Wroclaw University of Health and Sport Sciences1 个研究点 分布在 1 个国家目标入组 663 人开始时间: 2025年2月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
663
试验地点
1
主要终点
Diastolic blood pressure

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
9 Years 至 14 Years(Child)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

"11 For Health" Program (Intervention group)

Experimental

干预措施: "11 For Health" (Other)

Standard Physical Education (Control group)

No Intervention

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

结局指标

主要结局

Diastolic blood pressure

时间窗: 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

时间窗: 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.

Health Knowledge

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

20m Sprint Test

时间窗: 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.

Hand Grip Test

时间窗: 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

时间窗: 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.

Resting Heart Rate

时间窗: 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.

Skeletal Muscle Mass

时间窗: 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.

Systolic Blood Pressure

时间窗: 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.

次要结局

  • 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))

研究者

发起方
Wroclaw University of Health and Sport Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adrian Drożdżowski

MSc

Wroclaw University of Health and Sport Sciences

研究点 (1)

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