| CTRI Number |
CTRI/2023/05/053216 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To understand the association between Dietary Patterns, Dyslipidemia and Sleep Quality amongst employees in a Garment Showroom in Mumbai.
|
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Scientific Title of Study
|
Association between Dietary Patterns, Dyslipidemia and Sleep Quality amongst employees in a Garment Showroom in Mumbai.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIDHEE KETAN SHETHIA |
| Designation |
STUDENT - MSc in CLINICAL NUTRITION AND DIETITICS |
| Affiliation |
DR. BMN COLLEGE OF HOME SCIENCE |
| Address |
338, RAFI AHMED KIDWAI RD,
MATUNGA EAST
MUMBAI - 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9619529646 |
| Fax |
|
| Email |
vidheeshethia01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LAKSHMI MENON |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
DR. BMN COLLEGE OF HOME SCIENCE |
| Address |
338, RAFI AHMED KIDWAI RD,
MATUNGA EAST
MUMBAI - 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
900302531 |
| Fax |
|
| Email |
lakshmimenon@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
VIDHEE KETAN SHETHIA |
| Designation |
STUDENT - MSc in CLINICAL NUTRITION AND DIETITICS |
| Affiliation |
DR. BMN COLLEGE OF HOME SCIENCE |
| Address |
338, RAFI AHMED KIDWAI RD,
MATUNGA EAST
MUMBAI - 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9619529646 |
| Fax |
|
| Email |
vidheeshethia01@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.BMN COLLEGE OF HOME SCIENCE |
|
|
Primary Sponsor
|
| Name |
VIDHEE KETAN SHETHIA |
| Address |
DR.BMN COLLEGE
338, AHMED KIDWAI RD,
MATUNGA EAST,
MUMBAI - 400019
|
| Type of Sponsor |
Research institution |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VIDHEE KETAN SHETHIA |
DR. BMN COLLEGE OF HOME SCIENCE |
338, Ahmed Rafi Rd,
Matunga East,
Mumbai - 400019
Mumbai
MAHARASHTRA |
9619529646
vidheeshethia01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SEVA MANDAL EDUCATION SOCIETYS INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No pregnant women |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Salesperson
Working for at least 9 hours a day, standing job
Employees who are willing to participate
Employees who can read and understand English or Hindi |
|
| ExclusionCriteria |
| Details |
Pregnant women
Employees not willing to participate |
|
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Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Dietary Patterns, Lipid profiles and Sleep Quality amongst employees in a Garment Showroom in Mumbai |
NA |
|
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Secondary Outcome
|
|
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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" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2023 |
| 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="10"
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
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|
Brief Summary
|
Aim: To evaluate the association between dietary patterns, dyslipidemia and sleep quality amongst employees in a Garment Showroom in Mumbai.
Objectives: 1) To identify the dietary pattern of salesmen using a 3 day Dietary Recall. 2) To screen for employees at risk using Selective Anthropometric Assessment. 4) To assess the sleep quality using the Pittsburgh Sleep Quality Index-PSQI. 4) To check the lipid profiles of at risk employees via biochemical analysis. 5) To confirm that there exists an association between dietary patterns, dyslipidemia and sleep quality.
Hypothesis: Improper dietary habits are not associated with Dyslipidemia and Poor Sleep Quality. Sample: Salesmen from a Garment Showroom in Mumbai
Sampling technique: Purposive & Stratified Random Sampling
Sample size: 150 employees (subjects) 20% of employees from the overweight strata (study participants)
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