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CTRI Number  CTRI/2019/07/020076 [Registered on: 08/07/2019] Trial Registered Prospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Changes in the prevalence of cardiometabolic risk factors among teenage school children in urban south India over a period of time 
Scientific Title of Study   Secular trends in the prevalence of cardiometabolic risk factors among teenage school children in urban south India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IDRFARH012 Version 1.1 dated 21 June 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A Ramachandran 
Designation  President 
Affiliation  India Diabetes Research Foundation 
Address  No 3 and 4 Montieth Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone    
Fax    
Email  research@ardiabetes.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Ramachandran 
Designation  President 
Affiliation  India Diabetes Research Foundation 
Address  No 3 and 4 Montieth Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone    
Fax    
Email  research@ardiabetes.org  
 
Details of Contact Person
Public Query
 
Name  Dr K Satheesh 
Designation  Senior Research Officer 
Affiliation  India Diabetes Research Foundation 
Address  No 3 and 4 Montieth Road Egmore

Chennai
TAMIL NADU
600008
India 
Phone    
Fax    
Email  satresearch01@gmail.com  
 
Source of Monetary or Material Support  
India Diabetes Research Foundation No 3 and 4, Montieth Road, Egmore, Chennai 600008 
 
Primary Sponsor  
Name  India Diabetes Research Foundation 
Address  No 3 and 4 Montieth Road Egmore Chennai Tamil Nadu 600008 
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 A Ramachandran  India Diabetes Research Foundation  No 3 and 4 Montieth Road Egmore
Chennai
TAMIL NADU 
9842363895

research@ardiabetes.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of India Diabetes Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  School children of age 12 - 18 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.Children both boys and girls between 12 – 18yrs age group
2.Parents and child willing to give informed consent
3.Children must be available for and willing to attend all evaluation visits
4.Willingness to follow the protocol requirements as evidenced by written informed consent
 
 
ExclusionCriteria 
Details  1.Children below the age of 12 years and above the age of 18 years
2.Parents or Child who is not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Secular trends in prevalence rates of central adiposity, dysglycaemia, dyslipidaemia, hypertension and insulin resistance among adolescent children in 2019 in comparison with 2006 data  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence of overweight and obesity   Baseline 
Changes in food habits and physical activity levels  Baseline 
 
Target Sample Size   Total Sample Size="2815"
Sample Size from India="2815" 
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)   01/08/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The prevalence of cardiometabolic risk is high among South Asians which manifests itself at an early age.  Studies have reported that unhealthy food choices, inadequate physical activity and lack of awareness on healthy lifestyle practices pose a huge threat to the increasing prevalence of metabolic abnormalities even at adolescence.  In an earlier study conducted in 2006, we reported that 68% of the children during their early adolescence had one or more of the cardiometabolic abnormalities such as obesity, central adiposity, increased blood pressure and presence of dysglycaemia and dyslipidaemia. The risk escalated with increasing weight. Therefore, it is imperative to sensitize the children on improving their lifestyle by conducting screening tests and health education programmes in schools by involving teachers. We have also shown in our study that teachers can be instrumental in imparting knowledge on the prevention of non-communicable diseases such as diabetes by promoting healthy behavioral changes. The proposed study will focus on a) changes in the prevalence of cardiometabolic risk factors over a 10 year period b) health education programme to school children c) recommendations to school teachers (tool-kit) to inculcate improved lifestyle practices to their students. 

 
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