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CTRI Number  CTRI/2026/02/103990 [Registered on: 16/02/2026] Trial Registered Prospectively
Last Modified On: 16/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Mixed Method 
Study Design  Other 
Public Title of Study   How Difficult Working Conditions Affect Long-Term Health Problems Among Informal Motor Vehicle Drivers 
Scientific Title of Study   Impact of Work-related Environmental Adversity on Non-Communicable Diseases in Unorganized Sector Motor Vehicle Operators: A Mixed Method Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Taejas Atheya 
Designation  Junior Resident 
Affiliation  Kasturba Medical College  
Address  Department of Community Medicine Kasturba Medical College Manipal Udupi Karnataka
Manipal, Udupi, Karnataka
Udupi
KARNATAKA
579104
India 
Phone  7597351367  
Fax    
Email  taejas.kmcmpl2024@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Muralidhar M Kulkarni 
Designation  Professor 
Affiliation  Kasturba Medical College  
Address  Department of Community Medicine Kasturba Medical College Manipal Udupi Karnataka
Manipal, Udupi, Karnataka
Udupi
KARNATAKA
579104
India 
Phone  9844810917  
Fax    
Email  murali.kulkarni@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Taejas Atheya 
Designation  Junior Resident 
Affiliation  Kasturba Medical College  
Address  Department of Community Medicine Kasturba Medical College Manipal Udupi Karnataka
Manipal, Udupi, Karnataka
Udupi
KARNATAKA
579104
India 
Phone  7597351367  
Fax    
Email  taejas.kmcmpl2024@manipal.edu  
 
Source of Monetary or Material Support  
ICMR DHR PG Thesis Grant 
 
Primary Sponsor  
Name  ICMR DHR PG Thesis Support 
Address  V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi- 110029 
Type of Sponsor  Research institution 
 
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 Taejas Atheya  Department of Community Medicine  Kasturba Medical College, Eshwar Nagar, Manipal
Udupi
KARNATAKA 
7597351367

taejas.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Unorganised Sector Motor Vehicle Operators which may or may not have NCDs and are facing Work Related Enviromental Adversity 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All the commercial motor vehicle operators of different vehicle segments, above 30 years who are working for privately owned transportation services and delivery services for more than a year and are providing consent to participate in the study. 
 
ExclusionCriteria 
Details  All the commercial motor vehicle operators of different vehicle segments, below 30 years who are working for any other transportation services and delivery services, working less than a year and are not providing consent to participate in the study. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A baseline data will be obtained about the prevalence of work-related environmental adversity and common NCDs among the motor vehicle operators of unorganized sector.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence of Heat Strain in the unorganised sector Motor vehicle operators  Based on the day of the study only for that day, no follow ups 
 
Target Sample Size   Total Sample Size="416"
Sample Size from India="416" 
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)   01/03/2026 
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="1"
Months="6"
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  

This study titled “Impact of Work-related Environmental Adversity on Non-Communicable Diseases in Unorganized Sector Motor Vehicle Operators: A Mixed Method Study” aims to assess the relationship between occupational environmental adversity and the burden of non-communicable diseases (NCDs) among commercial motor vehicle operators working in the unorganized sector. Work-related environmental adversity refers to negative workplace conditions such as long working hours, lack of fixed breaks, job insecurity, stress, heat exposure, and absence of social security benefits under the Unorganised Workers’ Social Security Act. Drivers employed in privately owned transport and delivery services are particularly vulnerable to these stressors, which may contribute to hypertension, diabetes mellitus, obesity, and dyslipidemia. With the rising burden of NCDs in India, as highlighted by the World Health Organization, it is important to understand how occupational adversity influences disease risk in this underserved population.

The study will use a mixed-method approach. Objective 1 involves a scoping review of literature from the past 10 years to explore existing evidence on the influence of work-related environmental adversity on NCD epidemiology in India. Objectives 2 and 3 will be addressed through a prospective cross-sectional study conducted among 416 commercial motor vehicle operators aged above 30 years, working for more than one year in privately owned transportation or delivery services in a coastal district of Karnataka. Stratified sampling will be done across four vehicle categories (two-wheelers, three-wheelers, taxis, and buses) based on the classification by the Ministry of Road Transport and Highways.

Data will be collected using a pretested questionnaire to assess sociodemographic details, lifestyle factors, and work-related environmental adversity using a validated scoring system. Heat strain will also be assessed using a standardized questionnaire. Clinical measurements including height, weight, waist-hip ratio, body mass index, and blood pressure will be recorded as per the World Health Organization approach. Random blood sugar will be tested for all participants, and lipid profile will be performed for those with central obesity. Data will be analyzed using descriptive statistics and multivariate logistic regression to determine associations between work-related adversity and NCD risk factors. Ethical approval will be obtained, and informed consent will be taken from all participants. The findings are expected to provide baseline evidence to support occupational health interventions and policy measures for unorganized transport workers.

 
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