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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Aga Khan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00533819
First received: September 20, 2007
Last updated: October 14, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Hypertension
Other: 6 months of healthy physical activity
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

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

Secondary Outcome Measures:
  • Body mass index [ Time Frame: 6 months ]
  • Maths scores [ Time Frame: 6 months ]

Estimated Enrollment: 280
Study Start Date: September 2007
Estimated Study Completion Date: May 2008
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   9 Years to 11 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533819

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

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00533819     History of Changes
Other Study ID Numbers: 07GS006CHS, 743-CHS/ERC-07
Study First Received: September 20, 2007
Last Updated: October 14, 2008
Health Authority: Pakistan: Research Ethics Committee

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014