| CTRI Number |
CTRI/2023/05/053241 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
24/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To conduct a Descriptive Cross sectional study on Burnout, Eating behavior, Physical activity, and Nutrition status among Employed women aged in between 18-55 years. |
|
Scientific Title of Study
|
Burnout, eating behavior, physical activity, and nutrition status among employed women aged in between 18-55 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amisha Bhayani |
| Designation |
PG student |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Smt Manjulaben Gunavantrai Shah department of Postgraduate Studies
Room no 902
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8108858243 |
| Fax |
|
| Email |
amishabhayani2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
professor |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Smt Manjulaben Gunavantrai Shah department of Postgraduate Studies
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9003072531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Menon |
| Designation |
professor |
| Affiliation |
Dr BMN College of Home Science |
| Address |
Smt Manjulaben Gunavantrai Shah department of Postgraduate Studies
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9003072531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN College of Home Science |
|
|
Primary Sponsor
|
| Name |
Amisha Bhayani |
| Address |
Dr. BMN College of Home Science 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019Â India |
| Type of Sponsor |
Other [self sponsored ] |
|
|
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 |
| Amisha Bhayani |
Dr BMN College of Home Science |
Smt Manjulaben Gunavantrai Shah department of Postgraduate Studies room no 902
Address - 338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019Â India
Mumbai
MAHARASHTRA |
8108858243
amishabhayani2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
none |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
-Subjects who work for 8 hours /day.
-Subjects aged between 18-55.
-Subjects who are non-remote employees – here non-remote workers mean - those who only work at a workplace that is not home
-Subjects willing to give consent.
|
|
| ExclusionCriteria |
| Details |
women who are aged below 18 years and above 55 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Employed women would be suffering from burnout assessed with the help of Copenhagen Burnout Inventory.
Most of employed women might be on the weaker side of nutrition status.
The time period of the study would be 8 months.
They might not be physically active thus negatively correlated to their eating behavior. |
baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
07/06/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim - to study the burnout, eating behavior, physical activity and nutrition status among employed women aged between 18-55 years of age
objective - To determine the level of burnout in the employed women. To study the eating eating behavior of the participants. To assess the nutrition status of the subjects. To classify subjects as per kuppuswamy index and correlate it with burnout, eating behavior, physical activity and nutrition status. To understand correlation between burnout, eating behavior, physical activity and nutritional status.
Methodology- study design - descriptive cross sectional. study sample - employed women from 18-55 years of age. sampling method- non probability. size - 150
inclusion criteria- subjects who work for 8 hours/ day. subjects aged between 18-55 years of age subjects who are non remote employees, here it means those who work at a work place not work from home.
exclusion criteria - subjects who work less than 8 hours/ day. subjects aged below 18 and above 55 years of age. subjects who work from home. |