| CTRI Number |
CTRI/2017/03/008046 [Registered on: 08/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the nutritional status,eating patterns and sleeping habits of children aged 9 to 15 years. |
|
Scientific Title of Study
|
Nutritional assessment,eating patterns and sleeping habits of children aged 9 to 15 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Anuradha Shekar |
| Designation |
Hod Food Science and Nutrition Department |
| Affiliation |
Dr B.M.N College of Home science |
| Address |
338, R.A Kidwai Road, Matunga, Mumbai
Mumbai
MAHARASHTRA
401109
India
Mumbai
MAHARASHTRA
401109
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Christy Thomas |
| Designation |
Student |
| Affiliation |
Dr B.M.N College of Home science |
| Address |
C/111,Trilok Darshan,B.P. Road,near Congress Office, Bhayander East
Thane
MAHARASHTRA
401105
India |
| Phone |
9833251636 |
| Fax |
|
| Email |
christythomas94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Christy Thomas |
| Designation |
Student |
| Affiliation |
Dr B.M.N College of Home science |
| Address |
C/111,Trilok Darshan,B.P. Road,near Congress Office, Bhayander East
Thane
MAHARASHTRA
401105
India |
| Phone |
9833251636 |
| Fax |
|
| Email |
christythomas94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 |
| Christy Thomas |
Dr B.M.N College of Home Science |
Clinical Nutrition & Dietetics Department
338, R.A Kidwai Road,
Matunga, MUMBAI
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9833251636
christythomas94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children aged 9 to 15 years for evaluation of nutritional assessment, eating patterns and sleeping habits. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1)Age group - 9-15 years
2)Males and females
3)School going children |
|
| ExclusionCriteria |
| Details |
1)Subjects with any disease conditions such as diabetes mellitus or kidney disorder or illness will be excluded.
2)Subjects residing outside Mumbai and Thane city |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/09/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
- This study is conducted to
assess the nutritional status and dietary adequacy of 9-15 years old
children.
- To
explore the sleeping pattern of 9 to 15 years old children.
- To
describe the eating pattern of 9 to 15 years old children.
- To
examine the relationship between:
a)
sleeping hours and fluid intake.
b)
meal timing and grade of obesity.
c)
consumption of bed time meal and obesity.
d)
dietary adequacy and grade of obesity. 5. The data will be analysed using SPSS Software with the help of a trained statistician. |