FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/12/060892 [Registered on: 28/12/2023] Trial Registered Prospectively
Last Modified On: 02/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Cohort 
Study Design  Other 
Public Title of Study
Modification(s)  		 Estimation of anthropometry indices, body composition and cardiometabolic risk factors in Indian children  
Scientific Title of Study   Pediatric Epidemiology and Child Health - Prospective Cohort Study in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rebecca Kuriyan Raj 
Designation  Professor and Head Division of Nutrition 
Affiliation  St. John’s Research Institute 
Address  Professor and Head, Division of Nutrition, St. John’s Research Institute Bangalore KARNATAKA 560034 India

Bangalore
KARNATAKA
560034
India 
Phone  9886002210  
Fax    
Email  rebecca@sjri.res.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rebecca Kuriyan Raj 
Designation  Professor and Head Division of Nutrition 
Affiliation  St. John’s Research Institute 
Address  Professor and Head, Division of Nutrition, St. John’s Research Institute Bangalore KARNATAKA 560034 India

Bangalore
KARNATAKA
560034
India 
Phone  9886002210  
Fax    
Email  rebecca@sjri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Rebecca Kuriyan Raj 
Designation  Professor and Head Division of Nutrition 
Affiliation  St. John’s Research Institute 
Address  Professor and Head, Division of Nutrition, St. John’s Research Institute Bangalore KARNATAKA 560034 India

Bangalore
KARNATAKA
560034
India 
Phone  9886002210  
Fax    
Email  rebecca@sjri.res.in  
 
Source of Monetary or Material Support  
United States Department of Agriculture (USDA) 
 
Primary Sponsor  
Name  Partially funded by United States Department of Agriculture (USDA) 
Address  United States Department of Agriculture (USDA) Jamie L. Whitten Building 1301 Independence Avenue, S.W., Washington, D.C 
Type of Sponsor  Other [International Government] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Wesley Bonam  Arogyavaram Medical Centre  Union Mission Tuberculosis Sanatorium Arogyavaram, Chittoor District
Chittoor
ANDHRA PRADESH 		 8571262228

wesleywesleyamc@yahoo.co.in 
Dr Rebecca Kuriyan Raj  St John’s National Academy of Health Sciences  1st floor admin block, Division of Nutrition, St. John’s Research Institute Bangalore KARNATAKA
Bangalore
KARNATAKA 		 988600210

rebecca@sjri.res.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Arogyavaram Medical Centre Institutional Ethics Committee for Human Participants  Approved 
Institutional Ethics Committee ,St. John’s Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children and adolescents 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL  
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  18.90 Year(s)
Gender  Both 
Details  Healthy children and adolescents
Children who are unlikely to relocate from catchment area of our research sites in Karnataka and Andhra Pradesh 
 
ExclusionCriteria 
Details  Children with chronic disease such as congenital disorders, physical deformities and any chronic illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Accurate estimates of anthropometry indices, body composition and cardiometabolic risk factors in Indian children aged 19 years  Baseline (1) 
 
Secondary Outcome  
Outcome  TimePoints 
Estimation of energy expenditure
Comparison of the double burden of malnutrition(DBM) with children from previous waves of
PEACH study
Burden & risk factors of DBM & health outcomes 		 Baseline (1) 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
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)   05/01/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The dual burden of malnutrition (co-occurrence of both under- and over nutrition) poses challenges for the design of screening and public health interventions to improve child and adolescent health. However, there is little representative population-level data from Southern India, especially among children beyond the first 1,000 days of life. The burden of overweight and obesity in children is rapidly rising in India. Data from the three waves of school-based study PEACH (Paediatric Epidemiology and Child Health) found the prevalence of overweight/obesity increased by 6% (from 15% to 21%) in last decade in urban South Indian children, which could be associated with onset of cardio metabolic risk factors at young age. The establishment of a prospective cohort is needed to elucidate the health consequences of double and triple burden of malnutrition and to provide critical data to inform screening and public health interventions to improve the health of children and adolescents in India.

 
Close