| CTRI Number |
CTRI/2025/08/092700 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the Health and Eating Habits of Mumbai B.E.S.T Bus Drivers. |
|
Scientific Title of Study
|
Assessment of Dietary pattern and Anthropometry measurements among B.E.S.T Bus drivers in Mumbai |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aaisha Mohammed Sajid Patel |
| Designation |
Student |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Dr BMN College of Home Science,Department of Clinical Nutrition and Dietetics,
338 R.A Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9082571996 |
| Fax |
|
| Email |
aaisha1825@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Anuradha Shekhar |
| Designation |
Retired Vice Principle and head of FSN department |
| Affiliation |
Retired Vice Principle and head of FSN department |
| Address |
A3/31 Shivaparvati housing society, sector 21 Nerul, Navi Mumbai, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Anuradha Shekhar |
| Designation |
Retired Vice Principle and head of FSN department |
| Affiliation |
Retired Vice Principle and head of FSN department |
| Address |
A3/31 Shivaparvati housing society, sector 21 Nerul, Navi Mumbai, 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9820617577 |
| Fax |
|
| Email |
shekaranuradha237@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aaisha Mohammed Sajid Patel |
| Address |
Dr BMN College of Home Science
Divya Rishi Apartment 338 R A Kidwai Marg Matunga East Mumbai Maharashtra, 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 Rupali Sengupta |
Dr. BMN College of Home Science |
Dr BMN College of Home Science,Department of Clinical Nutrition and Dietetics 338, R.A. Kidwai Road, Matunga, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
9892415789
rupali@bmncollege.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 |
Individual with no disease condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
B.E.S.T Bus Drivers currently employed /residing in Mumbai
Individual aged 25-50 years
Males
Those who willing to give informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Individual who are not a Bus Driver at B.E.S.T
Individual above 50 or below 25 years
Females
B.E.S.T Driver who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the correlation between dietary pattern and Anthropometry measurements among B.E.S.T Bus drivers in Mumbai |
21 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the nutritional status using Food Frequency questionnaire
To assess the nutritional status using Anthropometry measurements
To see their dietary pattern and lifestyle behavior |
At the time of Data collection |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/08/2025 |
| 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="5"
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
|
Obesity and related metabolic illnesses have become more prevalent worldwide and bus drivers are one occupational groups that is especially at risk because of their sedentary lifestyle and erratic work schedules. Bus drivers in Mumbai who work long shifts for the Brihan Mumbai Electric Supply and Transport (B.E.S.T) sometimes struggle to keep up good eating habits. Such groups have been found to have a higher risk of visceral adiposity, which is associated with an elevated risk of cardiovascular disease and type 2 diabetes. Dietary pattern is an important factor in the development of visceral adiposity. Any studies have indicated a correlation between the buildup of belly fat and diets high in processed meals, high fat, snacks and animal products. The purpose of this study is to evaluate and comprehend the interrelated elements of dietary habits and anthropometry measurements among Mumbai-based B.E.S.T. employees in order to identify any possible linkages and problem areas that might need attention. |