HypertensionPhase 2NCT00533819
Exercise Intervention in Female School Children: Effect on Blood Pressure, Body Mass Index (BMI), and Maths Scores
A Phase 2 study testing 6 months of healthy physical activity in people with Hypertension, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Healthy physical activity decreases blood pressure in young female school children. It also has effects on BMI and maths scores. Read more about this study
- Who is it for?
- Ages 9 to 11 years, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- 6 months of healthy physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2007to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
4 Public Sector Schools
Karachi, Sindh, 74800
Aysha Almas, MBBs, FCPS
About this study
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
Healthy physical activity decreases blood pressure in young female school children. It also has effects on BMI and maths scores.
Read the 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
- Being tested
- 6 months of healthy physical activity
- Keywords
- Exercise intervention, Maths Scores, Blood pressure, Female school children, Body mass index
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 months of healthy physical activityOther
half an hour of healthy physical activity including 20 minutes aerobic, 5 minutes warm up and cool down, 4 days a week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: 6 months of healthy physical activity |
| 2 | No intervention | would have routine physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 6 months
Secondary outcomes (2)
Body mass index
Measured: 6 months
Maths scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startSep 2007
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Aysha Almas, MBBS, FCPS, Principal investigator, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533819
- Sponsor's protocol ID
- 07GS006CHS
- Other IDs
- 743-CHS/ERC-07
- Status last verified
- Oct 2008
- First submitted
- 20 Sep 2007
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16421350Almas 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.
PubMed 23661575
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00533819
- Acronym / sponsor ID
- 07GS006CHS
- Conditions
- Hypertension
- Keywords
- Exercise intervention, Maths Scores, Blood pressure, Female school children, Body mass index
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- May 2008 (estimated)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: 6 months of healthy physical activity |
| 2 | No intervention | –would have routine physical activity |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 months of healthy physical activityhalf an hour of healthy physical activity including 20 minutes aerobic, 5 minutes warm up and cool down, 4 days a week | Other | 1 |
Primary outcome
Blood pressure
Time frame: 6 months
2 secondary outcomes
Body mass index
Time frame: 6 months
Maths scores
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
- Background: PubMed 16421350Yin 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.
- Derived from this study: PubMed 23661575Almas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysha Almas, MBBS, FCPS principal investigator
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 6 months of healthy physical activity in people with Hypertension, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysha Almas, MBBS, FCPS (Medicine) (92-0333-3512-433, aysha.almas@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00533819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.