| 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
|
|
|
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
|
|
|
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. |