Soumitra Kumar1, Saumitra Ray2, Tanmay Mahapatra3, Kinnari Gupta4, Sanchita Mahapatra5, Mrinal K Das6, Santanu Guha7, Pradip K Deb6, Amal K Banerjee6. 1. Professor (Cardiology), Dept. of Medicine, Vivekananda Institute of Medical Sciences, Kolkata, India. Electronic address: dr.soumitrakumar@gmail.com. 2. Professor (Cardiology), Dept. of Medicine, Vivekananda Institute of Medical Sciences, Kolkata, India. 3. Medical Research Director, Mission Arogya Health and Information Technology Research Foundation, Kolkata, India. 4. Registrar (Non Invasive Cardiology), Medica Superspecialty Hospital, Kolkata, India. 5. Head of the Department (Epidemiology), Mission Arogya Health and Information Technology Research Foundation, Kolkata, India. 6. Consultant Cardiologist, Kolkata, India. 7. Professor (Cardiology), Medical College, Kolkata, India.
Abstract
BACKGROUND: Increasing burden of cardiovascular risk-factors among adolescent school-children is a major concern in India. Dearth of information regarding the burden of these factors and the efficacy of educational intervention in minimizing them among urban school-students of India called for a school-based, educational intervention involving a representative sample of these students and their caregivers. METHODOLOGY: Using a randomized-controlled design with stratified-random sampling, 1000 students (approximately 50/school) of 9th grade from 20 randomly selected schools (representing all socio-economic classes and school-types) and their caregivers (preferably mothers) will be recruited. Objectives of the study will include: estimation of the baseline burden and post-interventional change in cardiovascular risk-factors, related knowledge, perception and practice among participants in Kolkata. DATA COLLECTION: After obtaining appropriate consent (assent for adolescents), collection of the questionnaire-based data (regarding cardiovascular disease/risk-factor related knowledge, perception, practice), anthropometric measurements, stress assessment and cardiological check-up (pulse and blood pressure measurement along with auscultation for any abnormal heart sounds) will be conducted for each participating students twice at an interval of six months. In between 6 educational sessions will be administered in 10 of the 20 schools randomized to the intervention arm. After the follow-up data collection, same sessions will be conducted in the non-interventional schools. DATA ANALYSES AND DELIVERABLE: Descriptive and inferential analyses (using SAS 9.3) will be conducted to determine the distribution of the risk-factors and efficacy of the intervention in minimizing them so that policy-making can be guided appropriately to keep the adolescents healthy in their future life.
RCT Entities:
BACKGROUND: Increasing burden of cardiovascular risk-factors among adolescent school-children is a major concern in India. Dearth of information regarding the burden of these factors and the efficacy of educational intervention in minimizing them among urban school-students of India called for a school-based, educational intervention involving a representative sample of these students and their caregivers. METHODOLOGY: Using a randomized-controlled design with stratified-random sampling, 1000 students (approximately 50/school) of 9th grade from 20 randomly selected schools (representing all socio-economic classes and school-types) and their caregivers (preferably mothers) will be recruited. Objectives of the study will include: estimation of the baseline burden and post-interventional change in cardiovascular risk-factors, related knowledge, perception and practice among participants in Kolkata. DATA COLLECTION: After obtaining appropriate consent (assent for adolescents), collection of the questionnaire-based data (regarding cardiovascular disease/risk-factor related knowledge, perception, practice), anthropometric measurements, stress assessment and cardiological check-up (pulse and blood pressure measurement along with auscultation for any abnormal heart sounds) will be conducted for each participating students twice at an interval of six months. In between 6 educational sessions will be administered in 10 of the 20 schools randomized to the intervention arm. After the follow-up data collection, same sessions will be conducted in the non-interventional schools. DATA ANALYSES AND DELIVERABLE: Descriptive and inferential analyses (using SAS 9.3) will be conducted to determine the distribution of the risk-factors and efficacy of the intervention in minimizing them so that policy-making can be guided appropriately to keep the adolescents healthy in their future life.
Authors: Patricia M Kearney; Megan Whelton; Kristi Reynolds; Paul Muntner; Paul K Whelton; Jiang He Journal: Lancet Date: 2005 Jan 15-21 Impact factor: 79.321