| CTRI Number |
CTRI/2024/05/067438 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Non-Communicable Diseases Risk Factors and its Determinants among Healthcare Workers of Tertiary Care Hospital |
|
Scientific Title of Study
|
Cardio-Metabolic Diseases Risk Factors and its Determinants among Healthcare Workers of Tertiary Care Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayank Sharma |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) Jawaharlal Nehru Medical College Wardha |
| Address |
3rd Floor Community Medicine Department Jawaharlal Nehru Medical College Wardha Sawangi (Meghe)
Wardha MAHARASHTRA 442107 India |
| Phone |
07014110120 |
| Fax |
|
| Email |
drmayanksharma1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abhay Gaidhane |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) Jawaharlal Nehru Medical College Wardha |
| Address |
3rd Floor Community Medicine Department Jawaharlal Nehru Medical College Wardha Sawangi (Meghe)
Wardha MAHARASHTRA 442107 India |
| Phone |
09765404075 |
| Fax |
|
| Email |
abhaygaidhane@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhay Gaidhane |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) Jawaharlal Nehru Medical College Wardha |
| Address |
3rd Floor Community Medicine Department Jawaharlal Nehru Medical College Wardha Sawangi (Meghe)
Wardha MAHARASHTRA 442107 India |
| Phone |
09765404075 |
| Fax |
|
| Email |
abhaygaidhane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education & Research (Deemed to be University),Sawangi (Meghe), Wardha- 442107, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education & Research |
| Address |
Sawangi (Meghe), Wardha- 442107, Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
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 Mayank Sharma |
Acharya Vinoba Bhave Rural Hospital |
Medicine outpatient department, room no. 102, ground floor, AVBRH Campus Wardha MAHARASHTRA |
07014110120
drmayanksharma1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hypertension and diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All healthcare workers of tertiary care hospital.
All those who volunteer to participate in the study and give consent. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcomes which include anthropometric indicators such as Body Mass Index (BMI), waist circumference, and waist-to-hip ratio; biochemical parameters like levels of fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides; and blood pressure measurements to determine the prevalence of hypertension. Behavioral factors including physical inactivity, dietary habits, tobacco use, and alcohol consumption will also be assessed. |
assessment will be done by the end of 24 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="322" Sample Size from India="322"
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)
|
30/05/2024 |
| 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="2" Months="0" 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
|
Cardio-metabolic diseases, encompassing conditions such as diabetes, hypertension, and dyslipidemia, pose a significant public health challenge globally, contributing to substantial morbidity and mortality rates. In India, the burden of these diseases is particularly pronounced, with the prevalence steadily/ rising, fueled by urbanization, sedentary lifestyles, and shifting dietary patterns. While considerable attention has been directed towards understanding and addressing cardio-metabolic risk factors in the general population, there remains a dearth of research focusing on specific occupational groups, particularly healthcare workers, who are themselves vulnerable to these/ conditions due to the nature of their profession. /Healthcare workers play a pivotal role in promoting health and managing diseases within their communities; however, the demanding/ nature of their work often leaves them susceptible to neglecting their own health needs. Factors such as long working hours, irregular mealtimes, and high levels of stress contribute to poor /lifestyle habits among healthcare workers, placing them at an increased risk for cardio-metabolic diseases. Despite their critical role in public health, limited research/ elucidates the prevalence and determinants of cardio-metabolic risk factors, specifically among healthcare workers in rural settings in India/. /Therefore, this study protocol aims to address this gap by conducting a comprehensive assessment of cardio-metabolic/ risk factors and their determinants among healthcare workers at AVBRH, a tertiary care hospital/ located in rural Wardha, Maharashtra, India. By elucidating the prevalence and determinants of these risk factors, the study seeks to inform evidence-based interventions tailored to the unique/ needs of healthcare workers in rural settings, thereby contributing to improving their health and well-being/.Bottom of Form |