| CTRI Number |
CTRI/2015/05/005755 [Registered on: 06/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
06/05/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Quality of life and fast food intake in hostelites and days scholars age 18-23 years |
|
Scientific Title of Study
|
Consumption of fast food and quality of living index in hostelites and days scholars between the age group of 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 |
Jyothi Mallarapu |
| Designation |
Student |
| Affiliation |
Dr. B. M. N. College of home science |
| Address |
338, R. A. Kidwai road, Matunga (E), Mumbai-400019
338, R. A. Kidwai road, Matunga (E), Mumbai-400019
Mumbai
MAHARASHTRA
400079
India |
| Phone |
9768378258 |
| Fax |
|
| Email |
jyotimallarapu27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha Shekar |
| Designation |
Guide |
| Affiliation |
Dr. B. M. N. College of home science |
| Address |
338, R. A. Kidwai road, Matunga (E), Mumbai-400019
338, R. A. Kidwai road, Matunga (E), Mumbai-400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
022-24026511 |
| Email |
Shekaranuradha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
JYOTI MALLARAPU |
| Designation |
student |
| Affiliation |
Dr. B. M. N. College of home science |
| Address |
x 9/2 phirojshanagar, creek side, godrej colony, vikhroli (E)
338, R. A. Kidwai road, Matunga (E), Mumbai-400019
Mumbai (Suburban)
MAHARASHTRA
400079
India |
| Phone |
9768378258 |
| Fax |
|
| Email |
jyotimallarapu27@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 |
| SELF |
X 9/2 Phirojshanagar, Creek side, Godrej colony, Vikhroli (E |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jyoti Mallarapu |
SNDT Hostel |
SNDT Womens University 1, Nathibai Thackersey Road, Mumbai 400020
Mumbai
MAHARASHTRA |
9768378258
jyotimallarapu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
participants selected are healthy young adolescent girls without any disease condition and nutritional supplementation |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Female |
| Details |
1. All the subjects have to be young women of age group from 18 years to 23 years
2. The subjects have to be residing in a hostel and days scholars are selected
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are below the age of 18 years and above the age of 23 years will not be selected for the study
2. Subjects who do not stay in hostel and other than days scholars will not be selected
3. Those who are on any type of nutritional supplements or have any disease will not be selected
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overweight |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| consumption of fast food in day scholars and hostelites |
consumption of fast food in day scholars and hostelites |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/04/2014 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim: To see the relation of the dietary patterns and the anthropometry how it relates to the Quality Of Life and nutritional status of hostelites and to compare the results with the days scholars v OBJECTIVE: · To assess the nutritional status of the young adolescent girls by anthropometry · To analyse the nutritional status by 24 hour food recall and FFQ · To assess the Quality of Life index of adolescent girls using a tool named “Health Wellness and Quality of Life’’ · To correlate the anthropometric measurements, Quality of Life index and dietary intake of the hostelites with the days scholars
|