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CTRI Number  CTRI/2022/01/039838 [Registered on: 31/01/2022] Trial Registered Prospectively
Last Modified On: 16/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on tobacco use among the tribals. 
Scientific Title of Study   A study on prevalence, dependence and factors associated with tobacco consumption among the indigenous tribal population in Wayanad, Kerala. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Haritha Jayaraj 
Designation  Postgraduate Student (MPH) 
Affiliation  Prasanna School of Public Health 
Address  Room No:62, Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7760960980  
Fax    
Email  haritha.jayaraj@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Kumar Sumit 
Designation  Assistant Professor-Senior Scale 
Affiliation  Prasanna School of Public Health 
Address  Room No:53, Assistant Professor-Senior Scale, Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8867620088  
Fax    
Email  kumar.sumit@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Kumar Sumit 
Designation  Assistant Professor-Senior Scale 
Affiliation  Prasanna School of Public Health 
Address  Room No:53, Assistant Professor-Senior Scale, Department of Health Policy, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8867620088  
Fax    
Email  kumar.sumit@manipal.edu  
 
Source of Monetary or Material Support  
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal-576104, Karnataka. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sunandha OB  Wayanad district, Kerala  PEEP, Room No:293 Goodalaikunnu, Kalpetta P.O Wayanad, Kerala. PIN-673121
Wayanad
KERALA 		 9526438091

othayothsunanda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
Office of the District Collector Wayanad  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Tobacco consumption among the Paniya tribal community 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Individuals of Paniya tribal origin both male and female of age above 18 years.
2) Both who do not use tobacco or use tobacco for a minimum duration of 12 months. 
 
ExclusionCriteria 
Details  1) Individuals who are suffering from severe mental disorders, cognitive impairment or very sick. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence, dependence and factors associated with tobacco consumption among the tribal population.  30/04/2022 
 
Secondary Outcome  
Outcome  TimePoints 
To understand the prevalence of both smoking and smokeless tobacco consumption, factors associated with and the level of dependence or physical addiction to the nicotine among them. The findings of the current study can be used as an advantage for the public health department to prioritize, plan and scale up effective tobacco awareness, control and cessation programs targeting the indigenous tribal population of Wayanad.  30/06/2022 
 
Target Sample Size   Total Sample Size="403"
Sample Size from India="403" 
Final Enrollment numbers achieved (Total)= "403"
Final Enrollment numbers achieved (India)="305" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2022 
Date of Study Completion (India) 28/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Tobacco use is a major public health issue, forms a significant predictor for a variety of chronic diseases, including cancer, lung disease, cardiovascular disease, and stroke. It is one of the leading causes of death and disease in India. Nearly 267 million adults in India of age 15 years and above are users of tobacco according to the report of Global Adult Tobacco Survey of 2016-17. Persons of tribal origin accounts for a quarter of India’s vulnerable population among whom tobacco consumption is higher and experiences a greater burden of diseases attributable to the adverse effects of tobacco use. Several studies are revealing a higher prevalence and dependence on both forms of tobacco among the tribals of Wayanad and their ignorance about the harmful effects of tobacco use, demanding greater attention for improving health awareness and welfare of the tribal community. The current study aims to assess the prevalence, dependence and factors associated with tobacco consumption among the indigenous tribal population of Wayanad. This cross-sectional quantitative study with a sample size of 403 will be conducted among the Paniya tribes of Sultha Bathery Taluk of  Wayanad as this particular taluk has the highest scheduled tribe population of the total population of the district. The sampling technique used will be convenience sampling. Written informed consent will be obtained from each study participant prior to the interview. Data will be collected by conducting face-to-face interviews using an interviewer-administered peer and content validated close-ended questionnaire which also includes the Fagerstrom Test for Nicotine Dependence Scale (for both smoking and smokeless tobacco). Interviews are conducted with the assistance of a local tribal NGO called PEEP Wayanad (People’s Action for Educational and Economic Development of Tribal People) for easy communication in the Paniya dialect which is a mixture of Malayalam, Tamil and Tulu. The findings of the current study can be used as an evidence generation at the local level and the baseline data can serve as an advantage for the public health department to address the existing gaps in coverage of anti-tobacco awareness programs, plan and implement education, control and cessation programs, strengthen IEC and behaviour change communication activities related to tobacco use targeting the tribal population of Wayanad. 
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