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CTRI Number  CTRI/2024/04/066330 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 21/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Brief Intervention module in increasing quit rate among smokeless tobacco users 
Scientific Title of Study   Efficacy of Brief Intervention (BI) module in enhancing abstinence period among smokeless tobacco (SLT) users in selected community of Assam. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sagarika Chetia 
Designation  Ph.D scholar 
Affiliation  LGB Regional Institute of Mental Health 
Address  LGB Regional Institute Of Mental Health, Dept. Of Psychiatric Nursing, Tezpur, Assam

Sonitpur
ASSAM
784001
India 
Phone  9101723493  
Fax    
Email  sagarika25chetia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sagarika Chetia 
Designation  Ph.D scholar 
Affiliation  LGB Regional Institute of Mental Health 
Address  C/O- Happy CHetia House- Staff hostel, LGB Regional Institute Of Mental Health, P.O-Tezpur P.S- Tezpur, Dist- Sonitpur PIN- 784001 Assam
Vill- Changmai gaon P.O- Gohain Gaon P.S- Lepetkata Dist- Dibrugarh PIN- 786007
Dibrugarh
ASSAM
784001
India 
Phone  9101723493  
Fax    
Email  sagarika25chetia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sagarika Chetia 
Designation  Ph.D scholar 
Affiliation  LGB Regional Institute of Mental Health 
Address  LGB Regional Institute Of Mental Health, Dept. Of Psychiatric Nursing, Tezpur, Assam

Sonitpur
ASSAM
784001
India 
Phone  9101723493  
Fax    
Email  sagarika25chetia@gmail.com  
 
Source of Monetary or Material Support  
LGBRIMH, Tezpur 
Self-funded 
 
Primary Sponsor  
Name  Sagarika Chetia 
Address  LGB Regional Institute Of Mental Health, Tezpur 
Type of Sponsor  Other [Self] 
 
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 Nurnahar Ahmed  Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health, Tezpur  Lokopriyo Gopinath Bordoloi Regional Institute of Mental Health, Tezpur
Sonitpur
ASSAM 
9854341201

anurnahar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, LGBRIMH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Smokeless tobacco users  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brief intervention  Brief intervention is designed to increase the quit rate of smokeless tobacco among the participants. Researcher will develop a brief intervention module which will be of 15 to 30 mins duration.  
Comparator Agent  Brief intervention   Waitlist control group will receive the Brief intervention after posttest.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age- ≥18 to 60 years, current user of smokeless tobacco (SLT), those occasionally use smoking tobacco and who can read and write Assamese
 
 
ExclusionCriteria 
Details  Only Betelnut users (without tobacco), person using other form of tobacco, other substance users, people attended any awareness program, people seeking treatment for nicotine dependence
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of brief intervention (BI) module in enhancing abstinence, awareness and perception on smokeless tobacco use.   1st time point: Baseline (at the time of random allocation of participants to the experimental and waitlist control group and pretest)
2nd time point: At one month of 1st session
3rd time point: At one month of 2nd session 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the socio-demographic profile of participants using smokeless tobacco in selected villages of Sonitpur district, Assam.
To explore the consumption of smokeless tobacco use in selected villages of Sonitpur district, Assam.
To determine awareness regarding hazards of smokeless tobacco use among participants of selected villages of Sonitpur district, Assam.
To assess the perception regarding smokeless tobacco use among participants of selected villages of Sonitpur district, Assam.
 
At 1st session 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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   Phase 1 
Date of First Enrollment (India)   01/04/2025 
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="11"
Days="30" 
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
Modification(s)  

Background: The use of tobacco is prevalent in all age groups throughout the world. In India, its use is culturally accepted in most parts of the country, and as such, it is also easily available. As per the Global Adult Tobacco Survey 2 (GATS 2) fact sheet for Assam (2016–17), the prevalence of smokeless tobacco use has increased significantly (i.e., 41.7%) from GATS 1 by 9 percentage points. Many studies have been conducted on smoking tobacco, but only a handful of interventional research studies are available on the use of smokeless tobacco in India, especially in the NE region. The aim of the study is to assess the efficacy of the Brief Intervention (BI) module for smokeless tobacco users in a selected villages of Sonitpur district, Assam. Methodology: The researcher will adopt a randomized controlled trial research design. Setting will be selected villages of Sonitpur district of Assam, and population will be smokeless tobacco (SLT) users. In the first phase of the study the content of the brief intervention module will be prepared based on the existing models and will be validated from experts in different related fields. Then in the second phase of the study, three randomly selected villages under Bihaguri PHC will be visited and houses will be selected randomly by using random number table. A total of 86 samples will be included in the study as per inclusion and exclusion criteria and by using lottery method randomization will be done to allocate samples in experimental and waitlist control group. Three visits will be done to the houses at one month interval. On the first day socio-demographic information will be collected from selected participants by using a socio-demographic proforma and pretest will be conducted for both experimental and waitlist control group by using the Fragerstrom Nicotine Dependence Scale (FTND), the Fragerstrom Nicotine Dependence-Smoking Tobacco (FTND-ST) Scale, The Alcohol, Smoking and Substance Involvement Screening Test V3.0 (ASSIST-V3.0), the University Rhode Island Change Assessment Scale (URICA), and semi-structured questionnaires to assess abstinence period, perception, and awareness regarding smokeless tobacco use. On the same day Brief Intervention will be provided only to the experimental group by using validated Brief Intervention Module. 2nd visit will be done at one month after 1st visit and posttest will be conducted for both the groups. On that day, after post test brief intervention will be provided to the waitlist control group. On the third visit booster session will be conducted for experimental group and posttest will be done for waitlist control group. After the required number of participants have provided their data, all of the data will be gathered and statistically examined by using descriptive and inferential statistics.

 
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