| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
School children of age 12 - 18 years |
|
|
Intervention / Comparator Agent
|
|
|
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.
|