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

NCT ID: NCT00533819

Last Updated: 2008-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-05-31

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

Conditions

Hypertension

Keywords

Exercise intervention; Maths Scores; Blood pressure; Female school children; Body mass index

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

6 months of healthy physical activity

Intervention Type: OTHER

half an hour of healthy physical activity including 20 minutes aerobic, 5 minutes warm up and cool down, 4 days a week

2

would have routine physical activity

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Principal Investigators

Aysha Almas, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Student

Locations

4 Public Sector Schools

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Aysha Almas, MBBS, FCPS (Medicine)

Role: CONTACT

Phone: 92-0333-3512-433

Email: aysha.almas@aku.edu

References

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.

Reference Type: BACKGROUND

PMID: 16421350 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23661575 (View on PubMed)

Other Identifiers

743-CHS/ERC-07

Identifier Type: -

Identifier Source: secondary_id

07GS006CHS

Identifier Type: -

Identifier Source: org_study_id