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CTRI Number  CTRI/2012/09/002973 [Registered on: 10/09/2012] Trial Registered Prospectively
Last Modified On: 07/09/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Educational intervention to affect the behaviour of the participants]  
Study Design  Other 
Public Title of Study   A study to test the effectiveness of a school-based educational program on risk factors related to heart diseases among high school students in selected rural schools 
Scientific Title of Study   A study to test the effectiveness of a school-based educational intervention on knowledge, attitude and practices related to cardiovascular risk factors among high school students in selected rural schools of Kolar district in Karnataka state, India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shailendra Kumar B Hegde 
Designation  Assistant Professor 
Affiliation  SRM Medical College and Research Centre 
Address  Department of Community Medicine SRM Medical College and Research Centre SRM University Potheri Village Kattankulathur Block Kanchipuram District Tamilnadu

Kancheepuram
TAMIL NADU
600010
India 
Phone  9176888696  
Fax    
Email  hegde.shailendra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shailendra Kumar B Hegde 
Designation  Assistant Professor 
Affiliation  SRM Medical College and Research Centre 
Address  Department of Community Medicine SRM Medical College and Research Centre SRM University Potheri Village Kattankulathur Block Kanchipuram District Tamilnadu

Kancheepuram
TAMIL NADU
600010
India 
Phone  9176888696  
Fax    
Email  hegde.shailendra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shailendra Kumar B Hegde 
Designation  Assistant Professor 
Affiliation  SRM Medical College and Research Centre 
Address  Department of Community Medicine SRM Medical College and Research Centre SRM University Potheri Village Kattankulathur Block Kanchipuram District Tamilnadu

Kancheepuram
TAMIL NADU
600010
India 
Phone  9176888696  
Fax    
Email  hegde.shailendra@gmail.com  
 
Source of Monetary or Material Support  
Division of Clinical Trials St Johns Research Institute Koramangala Bangalore 
 
Primary Sponsor  
Name  St Johns Research Institute 
Address  Division of Clinical Trials St Johns Research Institute Opposite BDA Complex Koramangala Bangalore 560034 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailendra Kumar B Hegde  Bangalore  Room No. 208, Department of Community Health, First Floor, Robert Koch Bhavan, St. Johns Medical College, Sarjapura Raod, Koramangala, Bangalore - 560034
Bangalore
KARNATAKA 
9176888696

hegde.shailendra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Medical College and Hospital Institutional Ethical Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy school children will be interviewed and administered an educational intervention to alter their knowledge, attitude and behaviour patterns with respect to certain cardiovascular risk factors 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational Package  Intervention comprises of educational package delivered twice at an interval of 6 months for a period of 1 year. Educational Package comprises of education to the children on three principal areas of cardiovascular risk factors namely dietary behaviors, physical activity & tobacco consumption using a set of educational modules in the local language (Kannada) Innovative local methods like storytelling, games, role-plays & preparation of charts by students would be used as per the method instructed in the module developed to make sure that the teaching is as interesting as possible. 
Comparator Agent  Non Intervention or Control Group  Educational package for cardiovascular risk factors will not be delivered to the school in this group They will get the usual school education as before 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Children studying in the 8th and 9th standard in the two Government high schools coming under Lakkur PHC area will be included in the study 
 
ExclusionCriteria 
Details  Those children who are absent at the time of the initial survey and intervention shall be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the knowledge score and level of risk factors will be used as primary and secondary outcome measures respectively  June 2013 
 
Secondary Outcome  
Outcome  TimePoints 
Levels of Risk factor  June 2013 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/09/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Non-communicable diseases are the leading causes of death globally, of which cardiovascular diseases are the most common. Cost effective interventions (educational & behavioural interventions) for the reduction of cardiovascular risk factors should be promoted especially in the low and middle income countries such as India; such interventions must start in childhood because this is the time when the disease processes start and when life style habits are formed. Further, schools offer an ideal setting of a captive population of adolescents for these interventions. Our hypothesis is that schools with students, who receive intervention in the form of an educational capsule, directed at reduction of cardiovascular risk factors will have improved knowledge, attitudes & practices regarding the same (when compared to before-intervention and to schools with students not receiving such an intervention).

The intervention package would comprise of education to the children on the three principal areas of cardiovascular risk factors i.e. dietary behaviors, physical activity & tobacco consumption using a set of educational modules developed by the investigators with technical help from experts in the field. Innovative & locally available methods like storytelling, games, role-plays & preparation of charts by students would be used. The intervention will be delivered over a period of 6 days. This kind of educational programme will be delivered twice during the period of 1 year at a gap of 6 months (Jan-Feb, Aug-Sep). So, a total of two educational programs will be held for the students in the intervention group. The students in the control arm will not receive any special educational intervention on cardiovascular risk factors. Knowledge and attitude scores will be developed using the interview schedule to assess the levels of knowledge and attitude at both baseline and following the intervention. The level of knowledge of students regarding risk factors for CVDs will be the primary outcome measure while the levels of risk factors (i.e. dietary practices, physical activity and use of tobacco) will be the secondary outcome measure.

With this study, we aim to provide evidence that a well designed educational intervention delivered in an innovative & interesting manner has an impact on the knowledge, attitude and practices related to cardiovascular risk factors of the children which in turn will improve their health status in the long run. By involving the education sector, the same model can be implemented in other schools as well, thereby improving the health status of an entire generation.

 
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