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

October 14, 2008 updated by: Aga Khan University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Aysha Almas, MBBS, FCPS (Medicine)
  • Phone Number: 92-0333-3512-433
  • Email: aysha.almas@aku.edu

Study Locations

  • Pakistan
    • Sind
      • Karachi, Sind, Pakistan, 74800
        • Recruiting
        • 4 Public Sector Schools
        • Principal Investigator:
          • Aysha Almas, MBBs, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Blood pressure
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Body mass index
Time Frame: 6 months
6 months
Maths scores
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aga Khan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aysha Almas, MBBS, FCPS, Student

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07GS006CHS
  • 743-CHS/ERC-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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