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Exercise Intervention in Female School Children: Effect on Blood Pressure, Body Mass Index (BMI), and Maths Scores

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ClinicalTrials.gov Identifier: NCT00533819
Recruitment Status : Unknown
Verified October 2008 by Aga Khan University.
Recruitment status was:  Recruiting
First Posted : September 21, 2007
Last Update Posted : October 15, 2008
Information provided by:
Aga Khan University

Brief Summary:
Healthy physical activity decreases blood pressure in young female school children. It also has effects on BMI and maths scores.

Condition or disease Intervention/treatment Phase
Hypertension Other: 6 months of healthy physical activity Phase 2

Detailed Description:
  • Primary Objective: To compare the effect of 6 months healthy physical activity on blood pressure in female school children (9-13 yrs) with those who have routine physical activity
  • Secondary objective: To compare the effect of 6 months of healthy physical activity on body mass index and maths scores with those who have routine physical activity
  • Study Design: It would be a non-randomized experimental study (community intervention trial). It is designed to test the effectiveness of exercise on reducing blood pressure and the effect on BMI and maths scores
  • Setting: The study would be conducted in 4 public sector schools in Karachi.
  • Study Population: The study population would be selected from 4 local public sector schools near our hospital, The Aga Khan University Hospital. Two schools would have intervention and 2 schools would serve as controls. Both groups would have a base line screening for the outcome variables and then at 6 months
  • Intervention: The intervention is 30 minutes of healthy physical activity; 4-times/week would be carried out for a period of 6 months. This would be carried out by certified physical trainers who are experts in training children in aerobic exercise. Intervention group will have half an hour session on exercise motivation and its benefits. The routine activity group will have a similar session at baseline.
  • Sampling technique: convenience sampling
  • Sample Size : A sample size of 126 (63 in each arm) achieves 80% power to detect a difference of 4.3 mm in systolic blood pressure between the null hypothesis mean of 110.3 and an alternative hypothesis mean of 105.7 with an estimated standard deviation of 9.7 and with significance level (alpha) of 0.05 using one sided one sample t test. Assuming that there could be a 10% dropout rate we plan to take a total sample size of 140 students. We multiplied the total sample size by 2 to account for the design effect between clusters (schools) and achieved a total sample size of 280 that is 140 in each arm.
  • Dependent variables or outcome variables: Primary outcome measure would be the blood pressure. Secondary outcome measures would be body composition including weight, BMI, central obesity, and maths score. Independent variable would be demographics (age, school class) and the intervention of healthy physical activity and measurement of food intake frequency

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Non Randomized Community Intervention Trial in 4 Public Sectors Schools in Karachi. Exercise Intervention in Female School Children: Effect on Blood Pressure, BMI, and Maths Scores
Study Start Date : September 2007
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Other: 6 months of healthy physical activity
half an hour of healthy physical activity including 20 minutes aerobic, 5 minutes warm up and cool down, 4 days a week
No Intervention: 2
would have routine physical activity

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Body mass index [ Time Frame: 6 months ]
  2. Maths scores [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female children of age 9-11 yrs who are enrolled in the public sector school with a compound facility would be included in the study. Intervention would be offered to those only who will have normal age specific weight in percentiles.

Exclusion Criteria:

  • Those who are suffering from any chronic illness due to they which cannot participate and those who are mentally or physically disabled will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533819

Contact: Aysha Almas, MBBS, FCPS (Medicine) 92-0333-3512-433 aysha.almas@aku.edu

4 Public Sector Schools Recruiting
Karachi, Sind, Pakistan, 74800
Principal Investigator: Aysha Almas, MBBs, FCPS         
Sponsors and Collaborators
Aga Khan University
Principal Investigator: Aysha Almas, MBBS, FCPS Student

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00533819     History of Changes
Other Study ID Numbers: 07GS006CHS
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008

Keywords provided by Aga Khan University:
Exercise intervention
Maths Scores
Blood pressure
Female school children
Body mass index