| 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
|
|
|
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
|
|
|
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. |