| CTRI Number |
CTRI/2014/02/004419 [Registered on: 18/02/2014] Trial Registered Retrospectively |
| Last Modified On: |
17/02/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To study the effect of anthropomorphic,physical activity and eating pattern on body composition of hostel girls in Mumbai between the age of 18 years to 23 years |
|
Scientific Title of Study
|
Assessment of the body composition and its correlation with other nutritional status of young women residing in hostel of Mumbai(18-23 years) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saloni M Shah |
| Designation |
Student (MSc Part II Clinical Nutrition and Dietetics |
| Affiliation |
Dr. Bhanuben Mahendra Nanavati College of Home Science |
| Address |
B1 905 9th Floor Lok Everest
Jata Shankar Dosa Road
Mulund (West)
Mumbai
Dr. B.M.N College of Home Science, R.A. Kidwai Road,
Matunga, Mumbai, 400 019. Affiliated to SNDT University
Mumbai (Suburban)
MAHARASHTRA
400080
India |
| Phone |
9920826278 |
| Fax |
02224026511 |
| Email |
smsshah15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saloni M Shah |
| Designation |
Student (MSc Part II Clinical Nutrition and Dietetics |
| Affiliation |
Dr. Bhanuben Mahendra Nanavati College of Home Science |
| Address |
B1 9th floor 905
Lok Everest
Jata Shankar Dosa Road
Mulund (west)
Mumbai
Dr. Bhanuben Mahendra Nanavati
College of Home Science 338 R.A.
Kidwai Road
affiliated to SNDT University
Mumbai (Suburban)
MAHARASHTRA
400080
India |
| Phone |
9920826278 |
| Fax |
02224026511 |
| Email |
smsshah15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Sengupta Guide |
| Designation |
HOD -MSc Clinical Nutrition and Dietetics |
| Affiliation |
Dr. Bhanuben Mahendra Nanavati College of Home Science |
| Address |
Seva Mandal Education Societys
Dr. Bhanuben Mahendra Nanavati
College of Home Science 338 R.A.
Kidwai Road
Matunga
Seva Mandal Education Societys
Dr. Bhanuben Mahendra Nanavati
College of Home Science 338 R.A.
Kidwai Road
Matunga
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
02224026511 |
| Email |
senguptarupali@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Saloni Shah |
Institute of Chemical Technology |
ICT girls hostel no 3
Nathalal Parekh Marg
Matunga East
Puranmal Singhani Rd
Mumbai (Suburban)
MAHARASHTRA |
9920826278
02225622728
smsshah15@gmail.com |
| Saloni Shah |
SNDT Womens University |
SNDT girls hostel
Sir Vithaldas Vidyavihar
Juhu Tara Road
Santacruz (West)
Mumbai (Suburban)
MAHARASHTRA |
9920826278
02225622728
smsshah15@yahoo.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 |
to check nutritional status |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Female |
| Details |
All the subjects have to be young women of age group from 18 years to 23 years
The subjects have to be residing in a hostel
|
|
| ExclusionCriteria |
| Details |
Subjects who do not stay in hostel will not be selected
Subjects who are below the age of 18 years and above the age of 23 years will not be selected for the study
Those who are on any type of nutritional supplements will not be selected
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in body composition of hostel girls which is influenced by their dietary pattern, their physical activity their anthropometry and the nutrients i.e macronutrients they consume |
body fat 25%
bone mass more than 1.9kg
RMR 2000 Kcal
muscle mass more than 60% of body weight
body water 45-50 %
visceral fat 1 to 12 range |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
dietary intake affecting physical activity and body fat & also anthropomety is affected by the life style and the eating pattern of the person
the financial and the psychological condition of the person is related to the eating and activity of the person which thereby affects the body metabolism of the individual |
changes in body fat%
total body water
RMR changes
bone mass in lower than the normal range
muscle mass is deranged
visceral fat is compromised |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
26/08/2013 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
the research aims at studing the body composition of fat%, bone mass, muscle mass, visceral fat, RMR, total body water% with the help of a machine (BC 545 ) which uses the method of bio electrical impedance where a small current is send throughout the body , these factors are influenced by the anthropometry of the girls living in hostel and how their physical activity is affecting their body and their dietary intake how they affect the hostel girls body composition. there are 200 subjects who are hostel girls who are being studied and correlated in their body composition. |