| CTRI Number |
CTRI/2019/01/017112 [Registered on: 16/01/2019] Trial Registered Prospectively |
| Last Modified On: |
14/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
WHAT FOOD CHILDREN PREFER TO EAT AND TO ALSO FIND OUT PREVALENCE OF OVERWEIGHT AND OBESITY IN CHILDREN BETWEEN 6-12 YEARS IN PUDUCHERRY SCHOOLS |
|
Scientific Title of Study
|
FOOD PREFERENCES AND PREVALENCE OF OVERWEIGHT AND OBESITY IN CHILDREN AGED 6- 12 YEARS IN PUDUCHERRY-A CROSS SECTIONAL STUDY
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
APEKSHA ANAND |
| Designation |
POST GRADUATE |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF PEDIATRICS
GROUND FLOOR D BLOCK
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PILLAYARKUPPAM,PUDUCHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9844296326 |
| Fax |
|
| Email |
apeksha.anand20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SOUNDARARAJAN P |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF PEDIATRICS
D BLOCK
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PILLAYARKUPPAM,PUDUCHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9844296326 |
| Fax |
|
| Email |
pediatrics@mgmcri.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
APEKSHA ANAND |
| Designation |
POST GRADUATE |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF PEDIATRICS
D BLOCK
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PILLAYARKUPPAM,PUDUCHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9844296326 |
| Fax |
|
| Email |
apeksha.anand20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and research institite |
|
|
Primary Sponsor
|
| Name |
MAHATMAGANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE
PILLAYARKUPPAM, PUDUCHERRY |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| APEKSHA ANAND |
Urban and rural schools of pondicherry |
Government and private middle school
Pondicherry
PONDICHERRY |
9844296326
apeksha.anand20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy school Children between 6 to 12 years |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)All children aged 6 to 12 years studying 1st- 6th grade in Puducherry. |
|
| ExclusionCriteria |
| Details |
1)Any child with acute sickness on the day of the visit.
2)Children who are wheel chair bound and children having deformities.
3)Children with known chronic diseases and obvious congenital anomalies/ syndromes.
4)Parents/ children who refuse to give consent.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of overweight and obesity among school going children 6- 12 years of age.
|
From the beginning till the end |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the food preferences among children aged 6- 12 years of age.
To find out if there is a correlation between unhealthy food preferences and obesity in children aged 6- 12 years.
|
From the beginning till the end of study |
|
|
Target Sample Size
|
Total Sample Size="720"
Sample Size from India="720"
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)
|
21/01/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Childhood obesity has reached epidemic proportions in developing countries.It often leads to adult obesity and cardiovascular complications. The rise of childhood obesity has placed the health of an entire generation at risk. Unhealthy food practices are one of the important contributing factors for the rising prevalence of obesity apart from sedentary lifestyle and other factors. Food preferences in early life determine the health during adulthood.With the advent of telecommunication and the influence of mass media food preferences in children is becoming biased. Advertisements are known to influence food choices of children. There is a paucity of studies on obesity and food preferences in 6- 12 year age group in India. Also, studies on food preference during childhood and comparison of food preferences among obese and non-obese children are lacking. A focus on early childhood feeding is a foundation for lifelong health and wellbeing. Hence there is a necessity to study the food preferences among children for us to devise interventional measures directed at prevention of obesity in the coming days. |