| 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
|
|
|
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
|
|
|
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. |