FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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.

 

 

 
Close