| CTRI Number |
CTRI/2024/11/077218 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
19/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"Understanding smokeless tobacco use among Fisherwomen in Udupi: How common it is and what influences it" |
|
Scientific Title of Study
|
A study on prevalence of smokeless tobacco usage and its associated factors among fisherwomen in Udupi Taluk, Karnataka
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nireeksha |
| Designation |
Primary Student Researcher |
| Affiliation |
Prasanna School of Public Health,MAHE,MANIPAL |
| Address |
Room number 60,Department of Global Public Health Policy and Governance, Prasanna School of Public Health,MAHE,Manipal,Karnataka,
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
8150932597 |
| Fax |
|
| Email |
nireeksha.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya |
| Designation |
Associate Professor- Senior scale |
| Affiliation |
Prasanna School of Public Health, MAHE,Manipal |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health,MAHE,Manipal,Karnataka,
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
8904569460 |
| Fax |
|
| Email |
vidya.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya |
| Designation |
Associate Professor- Senior scale |
| Affiliation |
Prasanna School of Public Health, MAHE,Manipal |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public Health,MAHE,Manipal,Karnataka,
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
8904569460 |
| Fax |
|
| Email |
vidya.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nireeksha |
| Address |
Department of Global Public Health Policy and Governance, Prasanna School of Public
Health,MAHE,Manipal,Karnataka, Udupi
KARNATAKA
576104
India
|
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Vidya |
Prasanna School of Public Health |
Department of Global Public Health Policy and Governance, Prasanna School of Public
Health,MAHE,Manipal,Karnataka, Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA |
8904569460
vidya.p@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 |
Fisherwomen aged 18 years and above |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Fisherwomen aged 18 years and above |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be measured by estimating prevalence and analysing associated factors of smokeless tobacco use among fisherwomen in Udupi |
April 2025-May 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Finding association between SLT use & sociodemographic factors among fisherwomen in Udupi |
May 2025-June 2025 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
25/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 cross sectional study aims to assess the prevalence and factors linked to smokeless tobacco usage among fisherwomen in Udupi Taluk, Karnataka. Based on the high national rates of smokeless tobacco use and the public health concerns it poses—such as oral cancer and reproductive issues—this research will fill the gap in data specific to fisherwomen, a demographic with limited existing studies. Using a validated questionnaire from the Global Adult Tobacco Survey (GATS) and a cluster sampling technique, data will be collected from fisherwomen across selected markets in Udupi. The findings will inform targeted interventions to reduce tobacco-related health risks in this community. |