CTRI Number |
CTRI/2012/08/002882 [Registered on: 13/08/2012] Trial Registered Retrospectively |
Last Modified On: |
14/08/2012 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Cluster Randomized Trial |
Public Title of Study
|
Evaluation of healthy setting approach for Non Communicable Diseases(NCDs)in schools of rural Ballabgarh |
Scientific Title of Study
Modification(s)
|
Implementation and evaluation of healthy setttings approach for prevention of non-communicable diseases in schoolchildren of middle schools of rural Ballabgarh, Haryana(India). |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
T-7/03.10.2008 Version1 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Deepika Singh |
Designation |
PhD Scholar |
Affiliation |
All India Institute of Medical Sciences |
Address |
Centre for Community Medicine
All India Institute of Medical Sciences
New Delhi
South DELHI 110029 India |
Phone |
01126594253 |
Fax |
011-26588522 |
Email |
drdeepika.aiims@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anand Krishnan |
Designation |
Additional Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Centre for Community Medicine
All India Institute of Medical Sciences
New Delhi
South DELHI 110029 India |
Phone |
01126594253 |
Fax |
011-26588522 |
Email |
kanandiyer@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Anand Krishnan |
Designation |
Additional Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Centre for Community Medicine
All India Institute of Medical Sciences
New Delhi
South DELHI 110029 India |
Phone |
01126594253 |
Fax |
011-26588522 |
Email |
kanandiyer@yahoo.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical Sciences,New Delhi |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences |
Address |
Centre for Community Medicine
All India Institute of Medical Sciences
Ansari Nagar
New Delhi-110029 |
Type of Sponsor |
Research institution and hospital |
|
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 Deepika Singh |
Intensive Field Practice Area Ballabgarh |
CRHSP Ballabgarh
Near General Bus Stand
Ballabgarh,Dist.Faridabad Faridabad HARYANA |
9910954455
drdeepika.aiims@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
All India Institute of Medical Sciences Ethics Sub Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
General condition normal and healthy |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Control arm |
No intervention |
Intervention |
Information,education and communication(IEC) material regarding physical activity,healthy diet and tobacco |
Posters,
Flip charts,
Animation films,
Health education lectures,
Fun activities for children once in an academic year for one year |
|
Inclusion Criteria
|
Age From |
10.00 Year(s) |
Age To |
16.00 Year(s) |
Gender |
Both |
Details |
Students of 6th and 7th classes present in their respective schools on the day of baseline survey with a written consent were included |
|
ExclusionCriteria |
Details |
Those absent on the day of school visit for baseline survey were excluded |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Change in knowledge and practices among schoolchildren about diet,physical activity and tobacco |
One school year |
|
Secondary Outcome
|
Outcome |
TimePoints |
Change in school environment with respect to physical activity,diet and tobacco |
One School year |
|
Target Sample Size
|
Total Sample Size="1078" Sample Size from India="1078"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
12/01/2009 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Introduction: In India, deaths from non – communicable diseases are projected to almost double to about 8 million a year by the year 2020 from about 4 million in 1990. A major part of this change in the disease profiles can be attributed to a shift in the lifestyle and behavioral risk factors in the population. Majority of these diseases (specifically cardiovascular diseases, diabetes, cancer and stroke) show a common risk factor profile: physical inactivity, increased consumption of high calorie food, decreased consumption of fruits and vegetables, and tobacco consumption. All these risk factors are modifiable and are related to health behavior. Studies have shown that behavioral modifications are more successful if implemented at an early age. Schools have long been recognized as potentially effective settings for public health initiatives as they access a large population of children and youth across broad ethnic and socioeconomic strata.
Objectives: 1) To develop, implement and evaluate healthy school guidelines regarding diet, physical activity & tobacco in schools of rural Ballabgarh.2) To assess the change in knowledge and practices of middle school children about diet, physical activity & tobacco after one year of a school based intervention in rural Ballabgarh.3) To assess the role of schools in health promotion at the community level.4) To estimate the cost of the above formulated school-based intervention.
Methods: A cluster randomized controlled trial was carried out from Jan 2009 to Feb 2010, in 40 middle schools of intensive field practice area of rural Ballabgarh, Haryana. Data was collected from 2348 students on their knowledge and practices regarding major risk factors of non-communicable diseases viz physical activity, diet and tobacco before starting the intervention to assess the baseline characteristics of the schools and students. An intervention package consisting of teachers training, school action plan and IEC (Information, education and communication) material was delivered to the intervention group schools. After the intervention, the survey was repeated in the same schools.
Results: Significant no of schools adapted the ‘No Tobacco policy’ but could not prevent shops from selling tobacco products within 100 metres.Schools adapted the policy of encouraging students to bring fruits & vegetables but the availability of salted snacks within the school environment did not come down. Periods on physical activity significantly increased & also the IEC material on display, this correlates well with the increased physical activity of the students. Number of students attending PT classes increased significantly along with the knowledge about beneficial effects of physical activity. The total time spent on watching TV also came down significantly in the IG (decreased by 14min/day) & increased by 1.5min/day in the CG). Consumption of fruits and vegetables increased and that of deep fried food decreased but no positive impact observed in consumption of salted snacks. Habit of purchasing eatables from outside did not improve in our study. The knowledge about harmful effects of second hand smoke improved significantly. Prevalence of current smoking as well as smokeless tobacco came down significantly.
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