| 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
|
|
|
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
|
|
|
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
|
|
|
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. |