| CTRI Number |
CTRI/2025/01/079011 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To identify the sleep wake and dietary pattern of college going girls aged 18-23 years |
|
Scientific Title of Study
|
Identification of Chronotypes and dietary patterns in female college going students aged 18-23 years
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nazneen Ilyas Shaikh |
| Designation |
Student |
| Affiliation |
Dr.BMN College of Home Science |
| Address |
Divya Rishi Apartment 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9359161145 |
| Fax |
|
| Email |
nazneenshaikh63202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha Shekhar |
| Designation |
Retired Associate Professor |
| Affiliation |
Dr.BMN College of Home Science |
| Address |
Divya Rishi Apartment 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuradha Shekhar |
| Designation |
Retired Associate Professor |
| Affiliation |
Dr.BMN College of Home Science |
| Address |
Divya Rishi Apartment,338 Rafi Ahmed Kidwai Rd, Matunga east ,Mumbai
MAHARASHTRA
400019
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharastra 400019 |
|
|
Primary Sponsor
|
| Name |
Nazneen Ilyas Shaikh |
| Address |
Dr.BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharastra 400019 |
| 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 |
| Dr Anuradha Shekhar |
Dr. BMN College of Home Science |
Dr BMN College Of Home Science Divya Rishi Apartment, 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019 Mumbai MAHARASHTRA India
Mumbai (Suburban)
MAHARASHTRA |
9820617577
shekaranuradha237@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Educational Society Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
N/A |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIl |
NIl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Female |
| Details |
females aged 18-23 years
College going Girls
Willing to participate
|
|
| ExclusionCriteria |
| Details |
Population greater than 18 less than 23
Individuals suffering from any serious disease
Individuals on Medications
Individuals with dietary restriction
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The study is expected to show that individual’s chronotype significantly influence their dietary habits
It is anticipated that those with a late chronotype ( evening types) will exhibit lower adherence towards a healthy diet.
|
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study is expected to show that individual’s chronotype significantly influence their dietary habits
It is anticipated that those with a late chronotype ( evening types) will exhibit lower adherence towards a healthy diet.
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
31/01/2025 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study aims to identify the chronotype and dietary patterns in female college going students aged 18-23 years . The objectives of the study are To identify the chronotype of female college students using morning eveningness questionnaire To Assess the dietary pattern of the female college attendees using Food Frequency Questionnaire
To examine the relationship between chronotype and nutritional profile in college going females |