An interventional study of 11 for Health Program in Physical Fitness, Health and Body Composition, sponsored by Namik Kemal University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Namik Kemal University · Not applicable, Interventional, and Other
This study aims to examine the effects of the 11 for Health program on physical fitness and health-related outcomes in fifth-grade students.
The study will use a quasi-experimental pretest-posttest design with a control group. Approximately 70 students from two fifth-grade classes at a public school in Türkiye will participate. One class will participate in the 11 for Health program. The other class will be the control group.
The intervention group will participate in the program twice a week for 11 weeks, with each session lasting 45 minutes. The program combines football-based physical activities with health education. The control group will not receive the program.
Students in both groups will undergo physical fitness and health assessments before and after the intervention. These assessments will include jumping performance, balance, change-of-direction performance, flexibility, body fat percentage, blood pressure, and resting heart rate. Researchers will compare changes in these measures between the two groups to evaluate the effects of the program.
The 11 for Health program will be implemented during school hours over 11 weeks, with two 45-minute sessions each week. Each week will include one "Play Football" session focusing on football-based physical activities, such as passing, dribbling, and shooting, and one "Play Fair" session integrating health education with physical activities. Health education topics will include personal hygiene, healthy eating, and avoiding harmful habits. Sessions will follow the 11 for Health instructor guide and will be delivered through interactive, age-appropriate activities. The control group will not receive the 11 for Health program during the study period.
Physical fitness and health-related outcomes will be assessed in both groups before and after the intervention using standardized testing procedures. Physical fitness assessments will include the T-Test to evaluate change-of-direction performance, the countermovement jump (CMJ) test to assess vertical jumping performance, and the single-leg balance test to evaluate postural control. The Sit-and-Reach Test will be used to assess flexibility. Jumping performance and balance will be assessed using force platforms.
Health-related assessments will include body fat percentage measured using bioelectrical impedance analysis. Systolic blood pressure, diastolic blood pressure, and resting heart rate will be measured using an automated blood pressure monitor.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
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Exclusion Criteria:
Students in this group will participate in the 11 for Health program twice a week for 11 weeks. Each session will last 45 minutes and will include football-based physical activities or health education activities.
Other: 11 for Health Program
Students in this group will not receive the 11 for Health program during the study period and will continue their usual school activities.
An 11-week school-based program consisting of two 45-minute sessions per week. The program combines football-based physical activities with health education.
Change in Countermovement Jump Height
Countermovement jump (CMJ) height will be measured using VALD ForceDecks force platforms. Jump height will be calculated using the impulse-momentum method and reported in centimeters (cm). Higher values indicate greater jump height.
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Single-Leg Balance: Center of Pressure Mean Velocity
Single-leg balance will be assessed using VALD ForceDecks force platforms. Center of pressure (CoP) mean velocity will be recorded in millimeters per second (mm/s) during a 30-second single-leg standing test. Lower values indicate less postural sway.
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in T-Test Completion Time
Change-of-direction performance will be assessed using the T-Test. Participants will complete a standardized course involving forward, lateral, and backward movements. Completion time will be recorded in seconds using timing gates. Lower values indicate faster performance.
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Body Fat Percentage
Body fat percentage will be assessed using a bioelectrical impedance analysis (BIA) device. Results will be expressed as a percentage of total body mass.
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Sit-and-Reach Test Performance
Flexibility will be assessed using the sit-and-reach test. Reach distance will be recorded in centimeters (cm).
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Systolic Blood Pressure
Systolic blood pressure will be measured using an automated blood pressure monitor and reported in millimeters of mercury (mmHg).
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Diastolic Blood Pressure
Diastolic blood pressure will be measured using an automated blood pressure monitor and reported in millimeters of mercury (mmHg).
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Change in Resting Heart Rate
Resting heart rate will be measured using an automated blood pressure monitor and reported in beats per minute (bpm).
Time frame: Baseline (Week 1) and post-intervention assessment (Week 13, approximately 12 weeks after baseline)
Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality considerations involving minors.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Namik Kemal University