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CTRI Number  CTRI/2023/10/059062 [Registered on: 23/10/2023] Trial Registered Prospectively
Last Modified On: 05/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational Intervention]  
Study Design  Other 
Public Title of Study   A comparison of knowledge of various food habits in school going children and prevalence of overweight and obesity in government and private schools in Mangalore 
Scientific Title of Study   A comparative study of knowledge and perception among school going adolescents regarding various food habits and prevalence of overweight and obesity in government and private schools in Mangalore 
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 Rishabh Jain 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Pediatrics, 7th floor Kasturba Medical Hospital, Attavara, Mangalore
Department of Pediatrics, 7th floor Kasturba Medical Hospital, Attavara, Mangalore
Dakshina Kannada
KARNATAKA
575001
India 
Phone    
Fax    
Email  dr.rishabhjain0810@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Major Rajesh S M 
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Department of Pediatrics, 7th floor Kasturba Medical Hospital, Attavara, Mangalore
Department of Pediatrics, 7th floor Kasturba Medical Hospital, Attavara, Mangalore
Dakshina Kannada
KARNATAKA
575001
India 
Phone  9343434344  
Fax    
Email  majorrajeshsm@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Major Rajesh S M 
Designation  Professor 
Affiliation  Kasturba Medical College 
Address  Department of Pediatrics, 7th floor Kasturba Medical Hospital, Attavara, Mangalore
Department of Pediatrics, 7th floor Kasturba Medical Hospital, Attavara, Mangalore

KARNATAKA
575001
India 
Phone  9343434344  
Fax    
Email  majorrajeshsm@yahoo.co.in  
 
Source of Monetary or Material Support  
Canara High School, Mangalore 
Government High School, Baikampady  
Government Pre University College High School Division, Surathkal 
Sharada Vidyalaya, Mangalore 
 
Primary Sponsor  
Name  Dr Rishabh Jain 
Address  Kasturba Medical College, Light House Hill Road, Mangalore, Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rishabh Jain  Canara High School  A.S.R. Pai road, Dongerkery Mangalore- 575003
Dakshina Kannada
KARNATAKA 
7060725542

dr.rishabhjain0810@gmail.com 
Rishabh Jain  Government High School  XR49+Q45, New Mangalore, Industrial Area, Baikampady, Mangaluru-575011
Dakshina Kannada
KARNATAKA 
7060725542

dr.rishabhjain0810@gmail.com 
Rishabh Jain  Government Pre University College High School Division  2RF4+WHH, Sarojini Rd, Madya, Surathkal, Chelairu HC, Karnataka 575030
Dakshina Kannada
KARNATAKA 
7060725542

dr.rishabhjain0810@gmail.com 
Rishabh Jain  Sharada Vidyalaya  S.K.D.B. Campus, Kodialbail, Mangalore–575003
Dakshina Kannada
KARNATAKA 
7060725542

dr.rishabhjain0810@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z685||Body mass index (BMI) pediatric,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Educational   Compare knowledge retention and prevalence of obesity and overweight in school going adolescents of government and private schools 
Intervention  Educational Intervention  Educational interventions regarding awareness of various foods and its effects in the form of pamphlets & reading material.The pre-intervention questionnaire will be given in first visit to the school and knowledge intervention will be given on the same day. Post intervention questionnaire will be filled after 2 months  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Students studying in 8th-12th standard 
 
ExclusionCriteria 
Details  Students not giving assent for participation
students who were absent on the first visit to the school
children on long term medication or suffering from chronic illness
parents denying consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the knowledge and attitude about food habits and lifestyle inducing obesity among adolescents of 8th to 12th standard  post intervention questionnaire will be filled after 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
To analyze and assess the change and retention of knowledge after interactive education about food habits and lifestyle changes  After 2 months 
 
Target Sample Size   Total Sample Size="423"
Sample Size from India="423" 
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)   01/11/2023 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

India is in the midst of a rapidly escalating ‘epidemic’ of Type II Diabetes and Coronary Heart Disease (CHD). Presently, India has more diabetic patients than any other country in the world, and it is predicted that CHD will soon become the leading cause of death in our country. Today Indians are at high risk for insulin resistance and central obesity, both forerunners of diabetes, CHD and other ‘life style’ disorders. It is now emerging convincingly that these disorders begin in childhood and manifest due to interactions and accumulation of various risk factors, throughout the life course. Pediatricians, therefore, have an important role in the prevention and control of the ‘epidemic’. It is indeed ironic that a problem of “plenty” viz., childhood obesity, has emerged while we are still fighting undernutrition and infectious disease. Childhood obesity was thought to be a problem of developed world but now it’s prevalence in developing countries is on the rise. There has been an increased intake of energy-dense foods that are high in fat, salt and sugars(HFSS).

 
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