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
|
|
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
|
|
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). |