| CTRI Number |
CTRI/2016/04/006863 [Registered on: 22/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
19/02/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Nutritional Status of Adolescents Who Consume Carbonated versus Non Carbonated Beverages |
|
Scientific Title of Study
|
A comparative study of nutritional status of adolescents who consume carbonated beverages versus non carbonated beverages |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuradha Shekar |
| Designation |
HOD Food Science and Nutrition |
| Affiliation |
Dr B.M.N college of home science |
| Address |
338 R.A kidwai road matunga mumbai 400019
338 R.A kidwai road matunga mumbai 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikita Paralkar |
| Designation |
Student |
| Affiliation |
Dr B.M.N college of home science |
| Address |
Dr B.M.N College of Home Science. 338 R.A kidwai road matunga mumbai 400019
Dr B.M.N College of Home Science. 338 R.A kidwai road matunga mumbai 400019
Mumbai
MAHARASHTRA
400014
India |
| Phone |
9930196758 |
| Fax |
|
| Email |
nikitaparalkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuradha Shekar |
| Designation |
HOD Food Science and Nutrition |
| Affiliation |
Dr B.M.N college of home science |
| Address |
338 R.A kidwai road matunga mumbai 400019
338 R.A kidwai road matunga mumbai 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Indian Education Society V.N Sule Guruji English Medium Secondary School |
|
|
Primary Sponsor
|
| Name |
Meenakshi Walke |
| Address |
Indian Education Society Raja Shivaji Vidya Sankul 135/145 Hindu Colony Dadar(east) Mumbai 400014 |
| Type of Sponsor |
Other [school] |
|
|
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 |
| Meenakshi Walke |
I.E.S V.N Sule Guruji English Medium Secondary School |
Indian Education Society Raja Shivaji Vidya Sankul 135/145 Hindu Colony Dadar (east) Mumbai 400014
Mumbai
MAHARASHTRA |
022-24142581
ies.ceo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nutritional status
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
samples will be adolescence from 13 to 18 years of age both male and female |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| meals |
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
NIL
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/11/2013 |
| 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="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a survey to compare the nutritional status of adolescence who consumed carbonated and non-carbonated beverages. the subjects were given questionnaire .Through questionnaire nutritional status will be assessed by anthropometric measurements (height,weight,BMI ,waist circumference),2day dietary recall (1weekday and 1weekend) and food frequency questionnaire about portion and consumption of beverages for both girls and boys.The physical activity in boys and menstrual pattern in girls will also be assesed by questionnaire only. |