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School Health Education Program in Pakistan(SHEPP) (SHEPP)

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ClinicalTrials.gov Identifier: NCT03303287
Recruitment Status : Unknown
Verified October 2017 by Aysha Almas, Aga Khan University.
Recruitment status was:  Recruiting
First Posted : October 6, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Aysha Almas, Aga Khan University

Brief Summary:
Pakistan is a developing country and there have been a considerable rise in obesity and hypertension in children in recent years. In this setting a focus on primary prevention of cardiovascular diseases is more cost effective than spending resources on secondary or tertiary prevention,. Primary prevention includes interventions to promote physical activity (> 30 minutes/day in school), healthy dietary habits (decreased consumption of sweetened beverages and snacks, and increased consumption of fruit and vegetables) and health education focusing on cardiovascular risk factors in school children. This would translate into healthier cardiovascular outcomes (eg. less hypertension, dyslipidemia and diabetes) in adult life. The investigators propose a school health education program for Pakistan (SHEPP) for children aged 9-11 years in 3 schools in Karachi for a period of one year. This program will comprise of 140 minutes physical activity/week (including aerobics):30 minutes aerobic PA(30*2=60) + 10 minutes (10*5=50)physical activity in assembly daily+ 1 minute between periods(1*6*5=30) and healthy diet and healthy heart teaching. Additionally teaching will also be given to teachers and parents, who will further reinforce these habits in children. We hypothesise that SHEPP will improve physical activity levels, dietary habits and knowledge about healthy heart in children, will decrease blood pressure, body mass index, waist circumference, at the end of the year. If this healthy behavior is carried on to adult life it will serve as an excellent primary prevention measure. The investigators , later on plan to study long term outcomes after implementation of this intervention.

Condition or disease Intervention/treatment Phase
Health Education Behavioral: School health education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: : Three schools under the Aga Khan Education Service in Karachi will be included in a two-arm parallel cluster intervention trial. All schools belong to lower to middle income class, at different locations, all having the same school curriculum. Baseline data will be collected from all three schools during a three month period by trained research staff
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: School Health Education Program in Pakistan(SHEPP) ; Impact on Lifestyle and Cardio-
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Arm Intervention/treatment
Experimental: intervention
School health education program in Pakistan(SHEPP): The health education program will be directed towards children, parents and teachers
Behavioral: School health education
School health education program in Pakistan(SHEPP): The health education program will be directed towards children, parents and teachers

No Intervention: control
usual



Primary Outcome Measures :
  1. increase in Minutes spent in school, out of school in physical activity [ Time Frame: 10 months ]
    • Physical activity levels(in school, out of school, moderate to vigorous physical activity and sedentary time) assessed by number of minutes spent in physical activity


Secondary Outcome Measures :
  1. decrease in blood pressure in mm [ Time Frame: 10 months ]
    blood pressure

  2. decrease in BMI in kg/m2 [ Time Frame: 10 months ]
    BMI= weight in kg/height in meter square

  3. increase in Number of fruits and vegetable/ decrease in sweetened beverages in a day [ Time Frame: 10 months ]
    • Dietary patterns in terms of fruits and vegetable serving, sweetened beverages and snacks/day

  4. Decrease in waist circumference in cm [ Time Frame: 10 months ]
    Decrease in waist circumference in cm



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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All children aged 8-11 years enrolled in the schools.

Exclusion Criteria:

  • Any child or adolescent suffering from any physical disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303287


Contacts
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Contact: Aysha Almas, FCPS 9221-34930051 aysha.almas@aku.edu

Locations
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Pakistan
Aga Khan Schools Recruiting
Karachi, Sindh, Pakistan
Contact: Anila Allana       anila.allana@akesp.org   
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Aysha Almas, FCPS Aga Khan University

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Responsible Party: Aysha Almas, Associate professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03303287     History of Changes
Other Study ID Numbers: HEC_4553
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aysha Almas, Aga Khan University:
health education