| CTRI Number |
CTRI/2024/04/065790 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Eating habits and nutritional status of female hostel students at Mysore University. |
|
Scientific Title of Study
|
Trends in consumption of ultra-processed foods among female hostel students of Mysore University |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anupama M |
| Designation |
MSc Student |
| Affiliation |
University of Mysore |
| Address |
Nutrition Counseling Room, Ground floor, Department of Food Science and Nutrition, University of Mysore, Manasagangotri Campus, Mysuru
Mysore
KARNATAKA
570006
India |
| Phone |
8105141703 |
| Fax |
|
| Email |
anustubby@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asna Urooj |
| Designation |
Professor |
| Affiliation |
University of Mysore |
| Address |
Department of Food Science and Nutrition, University of Mysore, Manasagangotri Campus, Mysuru
Mysore
KARNATAKA
570006
India |
| Phone |
9448489334 |
| Fax |
|
| Email |
asnaurooj@foodsci.uni-mysore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Asna Urooj |
| Designation |
Professor |
| Affiliation |
University of Mysore |
| Address |
Department of Food Science and Nutrition, University of Mysore, Manasagangotri Campus, Mysuru
Mysore
KARNATAKA
570006
India |
| Phone |
9448489334 |
| Fax |
|
| Email |
asnaurooj@foodsci.uni-mysore.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anupama M |
| Address |
Department of Studies in Food Science and Nutrition, University of Mysore, Manasagangotri campus, Mysuru-570006 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Anupama M |
University of Mysore |
Nutrition Counseling Room, Ground floor, Department of Studies in Food Science and Nutrition, Manasagangotri Campus, University of Mysore, Mysuru 570006
Mysore
KARNATAKA |
8105141703
anustubby@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee, University of Mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women hostelites between the ages of 20-35 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Female hostel students living in university of Mysore women’s hostels in Manasagangotri campus for the 6 months and willing to participate. |
|
| ExclusionCriteria |
| Details |
Female hostel students living in the University of Mysore women’s hostel for the past few days will not be included in this study.
Female hostel students aged above 35 or below 20 years staying in and around the campus other than University of Mysore women’s hostel are not included in this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dietary information- Food frequency questionnaire for ultra-processed food, 24 hour recalls of two non-consecutive days and Minimum Dietary Diversity for Women |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anthropometric measurements- Height and weight
Body composition as analysed by bioelectrical impedance
Biochemical parameter- Haemoglobin by finger prick method and digital haemoglobinometer
Physical activity- IPAQ-SF |
At baseline |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an observational, cross-sectional study aimed at assessing the
trends in consumption of ultra-processed foods among female hostellers at the
University of Mysore. Further, the study will not only assess their consumption
of ultra-processed foods, body composition, blood hemoglobin, dietary
diversity, and physical activity, but also create awareness about
ultra-processed foods and their advantages and health implications of
overconsumption. Further, the obtained data will help us in planning and
promoting nutrition education among young women, aiming to reduce high-fat,
sugar, and salt food consumption, which otherwise leads to obesity and
increases the risk of non-communicable diseases. |