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CTRI Number  CTRI/2025/07/090893 [Registered on: 15/07/2025] Trial Registered Prospectively
Last Modified On: 14/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Impact of a Comprehensive Health Module on the Well-being of Beedi Rollers in Kateel Village, Dakshina Kannada 
Scientific Title of Study   Effectiveness of a Multi-Component Modular Intervention on Morbidity patterns among Beedi Rollers in Kateel village of Dakshina Kannada district 
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 Aditya K 
Designation  Post-Graduate 
Affiliation  Kasturba Medical College Mangalore,Manipal Academy of Higher Education,Manipal, India 
Address  Department of Community Medicine, Kasturba Medical College Mangalore, Light house hill road, Hampankatta,Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  6382218001  
Fax    
Email  aditya1.kmcmlr2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rekha T 
Designation  Professor  
Affiliation  Kasturba Medical College Mangalore,Manipal Academy of Higher Education,Manipal, India 
Address  Department of Community Medicine, Kasturba Medical College Mangalore, Light house hill road, Hampankatta,Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449082214  
Fax    
Email  rekha.thapar@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Rekha T 
Designation  Professor  
Affiliation  Kasturba Medical College Mangalore,Manipal Academy of Higher Education,Manipal, India 
Address  Department of Community Medicine, Kasturba Medical College Mangalore, Light house hill road, Hampankatta,Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449082214  
Fax    
Email  rekha.thapar@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India 
 
Primary Sponsor  
Name  Dr Aditya K 
Address  Department Of Community Medicine, Kasturba Medical College Mangalore, Light house hill road, Hampankatta,Mangalore 
Type of Sponsor  Other [Self Funded] 
 
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 Aditya K  Kasturba Medical College,Mangalore  Department of Community Medicine,Kasturba Medical College Mangalore, Light house hill road, Hampankatta,Mangalore
Dakshina Kannada
KARNATAKA 
6382218001

aditya1.kmcmlr2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Morbidities associated with Beedie rolling 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multi-Component Modular Intervention   The participants in the intervention arm will receive the multi-component modular educational intervention at baseline (0 months), 3 months, and 6 months. 
Comparator Agent  Standard care  Standard care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Willing to provide informed consent
Adults aged more than or equal to 18 years
Engaged in beedi rolling for more than or equal to 1 year
 
 
ExclusionCriteria 
Details  Severe physical impairment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Effectiveness of multi-component modular educational intervention in reducing morbidities among beedi rollers  At Baseline, 3rd month, 6th month and 9th month  
 
Secondary Outcome  
Outcome  TimePoints 
1.Prevalence of various morbidities among beedi rollers of Kateel in Dakshina Kannada District
2.Knowledge, Perceptions & Attitudes related to beedi rolling & its harmful effects among them. 
At Baseline, 3rd month, 6th month & 9th month  
 
Target Sample Size   Total Sample Size="304"
Sample Size from India="304" 
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)   31/07/2025 
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  

The study titled "Effectiveness of a Multi-Component Modular Intervention on Morbidity Patterns among Beedi Rollers in Kateel Village of Dakshina Kannada District" focuses on reducing occupational health issues among beedi rollers using a structured educational intervention. Beedi rolling is a labor-intensive, low-income, home-based occupation predominantly carried out by socioeconomically disadvantaged women. These workers are continuously exposed to tobacco dust, poor posture, inadequate ventilation, and lack of protective equipment, leading to high rates of respiratory illnesses, musculoskeletal pain, skin conditions, and reproductive health problems.

The study will be conducted in two phases. Phase I uses qualitative methods, including Focus Group Discussions (FGDs) and Key Informant Interviews (KIIs), to explore health perceptions, morbidity patterns, and barriers to health care seeking among beedi rollers and stakeholders. Based on the findings, a multi-component educational module will be developed. The module will address occupational health risks, personal hygiene, protective measures, nutrition, early symptom recognition, and awareness of government schemes. It will be delivered through audiovisual presentations, flipcharts, and mobile phone message reinforcements.

In Phase II, a cluster randomized controlled trial will be conducted across 8 villages, enrolling 304 beedi rollers equally divided into intervention and control groups. The intervention group will receive the module at baseline, 3, and 6 months, while both groups will be assessed at baseline, 3, 6, and 9 months. The study will use a validated tool to evaluate musculoskeletal, respiratory, and skin symptoms, functional disability, and general health. Physical and biochemical measurements, including BMI, hemoglobin, and blood pressure will also be measured.

The data collected will be analyzed to assess changes over time within and between groups. The study anticipates that the intervention will lead to a significant reduction in morbidity prevalence, improvement in functional health status, and better health-seeking behavior among beedi rollers.

 

 
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