- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07542574
"11 for Health" in Pakistan - Effects on Physical Fitness, Health Knowledge and Well-being of 8-14-year-old Schoolchildren
"11 for Health" in Pakistan - Effects of a School-Based Football Intervention Programme on Cardiorespiratory Health, Physical Fitness, Health Knowledge and Well-being of 8-14-year-old Schoolchildren
This study examined the effects of a school-based football intervention, the "11 for Health" (11fH) programme, on cardiorespiratory health, musculoskeletal fitness, health knowledge and well-being among Pakistani school children.
The main questions it aimed to answer were:
- Does the programme enhance Pakistani schoolchildren's cardiorespiratory health and physical fitness, including blood pressure, resting heart rate, aerobic capacity, horizontal jumping ability, agility, 30-m sprint, postural balance, BMI and waist circumference?
- Does it improve their health knowledge and well-being?
Researchers compared students who participated in the "11 for Health" intervention to those who continued their regular school curriculum. 254 fifth- and sixth-grade students (126 boys, 128 girls) from five schools in Islamabad participated in this study, allocated to an 11-week intervention group, a 5-week intervention group, and a control group.
Researchers tested all groups before and after the intervention. Cardiorespiratory health and physical fitness were assessed with standardized tests. Health knowledge and well-being were measured with validated Urdu questionnaires.
Study Overview
Status
Intervention / Treatment
Detailed Description
In developing countries like Pakistan, limited funding, infrastructure, and policy support pose challenges for promoting structured physical activity among school-aged children. These gaps result in low physical activity levels, with consequences extending beyond individual health to national healthcare systems and societal well-being.
Despite growing interest in improving physical education in Pakistan, current initiatives remain fragmented and under-researched. Introducing a structured, football-based physical and health education model such as "11 for Health" into this context offers an opportunity to test a scalable and contextually relevant approach.
The "11 for Health" programme is designed to deliver health education through physical activity using football drills and small-sided games. The intervention comprises 90 minutes of football-related activities per week, integrated with the delivery of ten health messages addressing communicable and non-communicable diseases (NCDs). Each health message is thematically linked to a specific football skill (Fuller et al. 2017). Since its in inception in South Africa in 2009, the "11 for Health" programme has been implemented across multiple regions, including Africa, South America, Oceania, Europe, and Southeast Asia, and a growing body of literature has analysed its effects on physical fitness, health knowledge, well-being, and cognitive outcomes. Its documented effectiveness in a range of international settings suggests potential for positive impact in Pakistan as well.
This study examined the "11 for Health" programme within the public school system and evaluated its effects on multiple aspects of health and well-being. These findings could help determine the programme's adaptability, thereby contributing critical insights into sustainable strategies for promoting health and physical fitness among Pakistani schoolchildren.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Islamabad, Pakistan
- Khursheed Hockey Ground, F-10/1, Islamabad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrollment in Grade 5 or Grade 6 in the participating schools during the 2023 to 2024 academic year
- Provision of written informed consent from parents or guardians together with assent from the students
Exclusion Criteria:
- Inability to provide consent or assent and medical conditions that prevented participation in football or other moderate-to-vigorous physical activities. Examples included severe mobility limitations, serious cardiovascular disease, or severe asthma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 11-week Intervention Group
The 11-week Intervention Group participated in the complete "11 for Health" program for 11 weeks.
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The "11 for Health" intervention consisted of two 45-minute sessions per week for 11 weeks, including a "Play Football" session that focused on developing specific football skills, and a "Play Fair" session that delivered health education through football-related activities, replacing traditional chalkboard instruction.
Small-sided games (3v3, 4v4) were included in every session as the main physical stimulus.
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Experimental: 5-week Intervention Group
The 5-week Intervention Group completed the last 5-week intervention program after returning school (the new semester began).
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The "11 for Health" intervention consisted of two 45-minute sessions per week for 11 weeks, including a "Play Football" session that focused on developing specific football skills, and a "Play Fair" session that delivered health education through football-related activities, replacing traditional chalkboard instruction.
Small-sided games (3v3, 4v4) were included in every session as the main physical stimulus.
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No Intervention: Control Group
The control group continued with their regular daily life and school activities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resting Heart Rate
Time Frame: before and at the end of the 11-week intervention
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Resting heart rate (RHR) was measured four times using a portable liquid crystal display (LCD) finger-type pulse oximeter. Prior to RHR measurement, participants were required to rest in a seated position for 15-20 minutes. Four measurements were taken for each participant, with at least 2-minute intervals between readings. Unit of Measurement: Beats per minute (bpm) |
before and at the end of the 11-week intervention
|
|
Systolic Blood Pressure and Diastolic Blood Pressure
Time Frame: before and at the end of the 11-week intervention
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Trained staff measured blood pressure using an aneroid sphygmomanometer. The first and fifth Korotkoff sounds were recorded as systolic (SBP) and diastolic (DBP) pressure. Participants rested seated for 15-20 minutes beforehand. Four readings were taken at intervals of at least two minutes. Unit of Measurement: Millimeters of Mercury (mmHg) |
before and at the end of the 11-week intervention
|
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Body Mass Index (BMI)
Time Frame: before and at the end of the 11-week intervention
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Weight and Height were combined to report BMI in kg/m^2. Height was measured to the nearest 0.1 cm using a yardstick. Weight was recorded with a 0.1 kg precision using a portable calibrated scale. These measurements were conducted with participants barefoot and wearing light clothing. Unit of Measurement: BMI in kg/m^2 |
before and at the end of the 11-week intervention
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Waist Circumference
Time Frame: before and at the end of the 11-week intervention
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Waist circumference (WC) was assessed at the midpoint between the lowest rib and the superior border of the iliac crest at the end of normal expiration, using a non-stretch measuring tape held parallel to the floor. Unit of Measurement: centimetre (cm) for the waist circumference |
before and at the end of the 11-week intervention
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Postural Balance
Time Frame: before and at the end of the 11-week intervention
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Postural balance was assessed using the Stork balance stand test. Participants placed their hands on hips, positioned one foot against the supporting leg's knee, and raised the supporting heel to balance on the ball of the foot. Timing began at heel lift and stopped if hands moved, the foot shifted, knee contact broke, or the heel touched down. Unit of Measurement: seconds (s) |
before and at the end of the 11-week intervention
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Jump Performance
Time Frame: before and at the end of the 11-week intervention
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Jump performance was assessed by standing long jump test. Each student performed two barefoot jumps. Starting with toes behind a line, feet parallel and shoulder-width apart, they squatted to 90° knee flexion with hands on hips. After two seconds, they jumped forward, keeping hands on hips. Unit of Measurement: Distance from line to heel was measured to the nearest centimetre (cm). |
before and at the end of the 11-week intervention
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Agility
Time Frame: before and at the end of the 11-week intervention
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The Arrow-head agility test is used to measure agility. Participants sprint from a start line to a middle cone, turn right around a side cone, circle the farthest cone, and return. Knocking over a cone requires a restart. Two attempts were made after one trial. The shorter time of the two attempts was recorded. Unit of Measurement: Seconds (s) - Time to complete the test |
before and at the end of the 11-week intervention
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30-metre Sprint
Time Frame: before and at the end of the 11-week intervention
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The participants performed two 30-metre sprints at their maximal speed with 2-3 minutes of rest between attempts. Three timers with stopwatches stood 6 metres perpendicular to the finish line. They started timing at the student's first movement and stopped when the upper body crossed the finish line. Unit of Measurement: The average time in seconds (s) given by testers. |
before and at the end of the 11-week intervention
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Cardiovascular Performance
Time Frame: before and at the end of the 11-week intervention
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Cardiovascular performance was evaluated with the Yo-Yo intermittent recovery level 1 children's test. The test took place outdoors at all schools. It consisted of repeated 16-metre shuttle runs with progressively increasing speed. Between runs, participants had a 10 second active recovery by jogging around a cone set 4 metres behind the start line. A prerecorded beep regulated the pace. Missing the beep twice terminated the test. Unit of Measurement: Total running distance in metres (m) |
before and at the end of the 11-week intervention
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Health Knowledge
Time Frame: before and at the end of the 11-week intervention
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A 34-item Urdu version health knowledge questionnaire assessed children's understanding of ten health topics related to the "11 for Health" programme before and after the intervention. Items used either a true/false/don't know format or multiple choice with four options. Correct answers received a score of 2, while incorrect or don't know responses scored 1. Unit of Measurement: Mean percentage and standard deviation of correct responses were calculated for each health message based on all individual answers. |
before and at the end of the 11-week intervention
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Well-being
Time Frame: before and at the end of the 11-week intervention
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An Urdu version of the adapted KIDSCREEN-27 questionnaire was used to measure well-being of the partcipants.
The 20 items covered four dimensions: physical well-being, psychological well-being, peers and social support, and school environment.
Items used a five-point Likert scale ranging from "never" to "always" or "not at all" to "extremely".
The subscale scores are converted to a standardized scale where the average is around 50 and the standard deviation is about 10.
Higher scores reflected better well-being.
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before and at the end of the 11-week intervention
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Madsen M, Elbe AM, Madsen EE, Ermidis G, Ryom K, Wikman JM, Rasmussen Lind R, Larsen MN, Krustrup P. The "11 for Health in Denmark" intervention in 10- to 12-year-old Danish girls and boys and its effects on well-being-A large-scale cluster RCT. Scand J Med Sci Sports. 2020 Sep;30(9):1787-1795. doi: 10.1111/sms.13704. Epub 2020 May 27.
- Moller TK, Larsen MN, Pfeffer K, Frydenlund SE, Ntoumanis N, Krustrup P. The effects of a combined physical activity and health education program on health knowledge and well-being of socially vulnerable children. Scand J Med Sci Sports. 2024 Apr;34(4):e14606. doi: 10.1111/sms.14606.
- Fuller CW, Orntoft C, Larsen MN, Elbe AM, Ottesen L, Junge A, Dvorak J, Krustrup P. 'FIFA 11 for Health' for Europe. 1: effect on health knowledge and well-being of 10- to 12-year-old Danish school children. Br J Sports Med. 2017 Oct;51(20):1483-1488. doi: 10.1136/bjsports-2016-096123. Epub 2016 Apr 29.
- Li Z, Krustrup P, Randers MB, Xu B, Yang W, Huang Z, Mao L. "11 for Health" in China - Effects on physical fitness in 9-11-year-old schoolchildren. Eur J Sport Sci. 2023 Dec;23(12):2291-2298. doi: 10.1080/17461391.2023.2227139. Epub 2023 Jul 1.
- Skoradal MB, Purkhus E, Steinholm H, Olsen MH, Orntoft C, Larsen MN, Dvorak J, Mohr M, Krustrup P. "FIFA 11 for Health" for Europe in the Faroe Islands: Effects on health markers and physical fitness in 10- to 12-year-old schoolchildren. Scand J Med Sci Sports. 2018 Aug;28 Suppl 1:8-17. doi: 10.1111/sms.13209. Epub 2018 Jun 8.
- Orntoft C, Fuller CW, Larsen MN, Bangsbo J, Dvorak J, Krustrup P. 'FIFA 11 for Health' for Europe. II: effect on health markers and physical fitness in Danish schoolchildren aged 10-12 years. Br J Sports Med. 2016 Nov;50(22):1394-1399. doi: 10.1136/bjsports-2016-096124. Epub 2016 Apr 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Reg. No. HPESS 007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Measurements: Data obtained from physical fitness tests (YYIR1C, standing long jump, arrowhead agility test, 30-metre sprint, Stork balance test), cardiorespiratory health measurements (e.g. BP, RHR), health knowledge and well-being assessments will be shared.
Data Anonymization: All shared data will be fully anonymized to ensure participant confidentiality. Personal identifiers such as names, birth dates, and schools will be removed. Data will be reviewed and aggregated where necessary to prevent the possibility of participant re-identification.
Data Format: The data will be provided in standardized file formats such as Excel (.xlsx) to support compatibility and ease of use in secondary analyses.
Access Control: Access to the shared IPD will be granted to qualified researchers who provide a valid research proposal, informed consent form(s) and agree to comply with data use agreements that ensure the data will be used solely for research purposes and not for commercial gain.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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