Exercise Intervention in Female School Children: Effect on Blood Pressure, Body Mass Index (BMI), and Maths Scores
Primary Purpose
Hypertension
Status
Unknown status
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
6 months of healthy physical activity
Sponsored by

About this trial
This is an interventional prevention trial for Hypertension focused on measuring Exercise intervention, Maths Scores, Blood pressure, Female school children, Body mass index
Eligibility Criteria
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.
Sites / Locations
- 4 Public Sector SchoolsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
would have routine physical activity
Outcomes
Primary Outcome Measures
Blood pressure
Secondary Outcome Measures
Body mass index
Maths scores
Full Information
NCT ID
NCT00533819
First Posted
September 20, 2007
Last Updated
October 14, 2008
Sponsor
Aga Khan University
1. Study Identification
Unique Protocol Identification Number
NCT00533819
Brief Title
Exercise Intervention in Female School Children: Effect on Blood Pressure, Body Mass Index (BMI), and Maths Scores
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Aga Khan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Healthy physical activity decreases blood pressure in young female school children. It also has effects on BMI and maths scores.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Exercise intervention, Maths Scores, Blood pressure, Female school children, Body mass index
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Arm Description
would have routine physical activity
Intervention Type
Other
Intervention Name(s)
6 months of healthy physical activity
Intervention Description
half an hour of healthy physical activity including 20 minutes aerobic, 5 minutes warm up and cool down, 4 days a week
Primary Outcome Measure Information:
Title
Blood pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Body mass index
Time Frame
6 months
Title
Maths scores
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysha Almas, MBBS, FCPS (Medicine)
Phone
92-0333-3512-433
Email
aysha.almas@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysha Almas, MBBS, FCPS
Organizational Affiliation
Student
Official's Role
Principal Investigator
Facility Information:
Facility Name
4 Public Sector Schools
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aysha Almas, MBBs, FCPS
12. IPD Sharing Statement
Citations:
PubMed Identifier
16421350
Citation
Yin Z, Gutin B, Johnson MH, Hanes J Jr, Moore JB, Cavnar M, Thornburg J, Moore D, Barbeau P. An environmental approach to obesity prevention in children: Medical College of Georgia FitKid Project year 1 results. Obes Res. 2005 Dec;13(12):2153-61. doi: 10.1038/oby.2005.267.
Results Reference
background
PubMed Identifier
23661575
Citation
Almas A, Islam M, Jafar TH. School-based physical activity programme in preadolescent girls (9-11 years): a feasibility trial in Karachi, Pakistan. Arch Dis Child. 2013 Jul;98(7):515-9. doi: 10.1136/archdischild-2012-303242. Epub 2013 May 9.
Results Reference
derived
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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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