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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details  Pregnant women 
 
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

 
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