| CTRI Number |
CTRI/2024/07/071710 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the usefulness of behavioral counselling with role modelling technique and video based tobacco cessation counselling among the adults of Paliyar Tribes |
|
Scientific Title of Study
|
Comparing the effectiveness of behavioral counselling using role modelling technique and video based tobacco cessation counselling among the adults of Paliyar Tribes-A Randomized Controlled Trial |
| 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 Mariya Shiney JE |
| Designation |
Postgraduate 2nd Year |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Indira Gandhi Institute of Dental Sciences,
SBV Pondicherry Campus,
Pillayarkuppam,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9629476807 |
| Fax |
|
| Email |
shineymtc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil M |
| Designation |
Professor and Head |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Indira Gandhi Institute of Dental Sciences,
SBV Pondicherry Campus,
Pillayarkuppam,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9486365954 |
| Fax |
|
| Email |
senthilm@igids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Senthil M |
| Designation |
Professor and Head |
| Affiliation |
Indira Gandhi Institute of Dental Sciences |
| Address |
Indira Gandhi Institute of Dental Sciences,
SBV Pondicherry Campus,
Pillayarkuppam,
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9486365954 |
| Fax |
|
| Email |
senthilm@igids.ac.in |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Dental Sciences,
SBV Pondicherry Campus,
Pillayarkuppam, Pondicherry-
607402 |
|
|
Primary Sponsor
|
| Name |
Dr Mariya Shiney J.E |
| Address |
Indira Gandhi Institute of Dental Sciences, SBV Pondicherry Campus, Pillayarkuppam, Pondicherry- 607402 |
| 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 Mariya Shiney JE |
Ponnaruvi |
Ponnaruvi 5284JVH Sirumalai
Tamil Nadu 624201
Dindigul
TAMIL NADU |
9629476807
shineymtc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
No Objection Certificate |
| Institutional Ethical Committee Indira Gandhi Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z603||Acculturation difficulty, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Role Model based Behavioral Counselling |
For test group Role model based behavior counselling technique on tobacco cessation will be given
Duration 6 months The interventions will be given at 1st month 3
rd month and 6th month Daily follow up sessions will be given by the role model selected |
| Intervention |
Video based tobacco cessation counselling |
For control group video based tobacco cessation counselling will be given
Duration 6 months
The video will be of 15 to 20 min of duration In the video harmful effects of tobacco use types of tobacco will be delivered How the study
subjects will deal with difficult situations and attitudes toward smoking and quitting how to cope
with negative moods with coping plans and how to deal with difficult risk situations
Every week phone interviewing will be done by the investigator
Interviewing will be conducted in the participants language of choice Daily follow up sessions will be done by the role model selected |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Study subjects who are 18 or older were included Study subjects who are motivated to quit smokeless tobacco within the next 3 months Study subjects who are able to read and write Study subjects who have access to mobile phones Study subjects who have access to internet
|
|
| ExclusionCriteria |
| Details |
Study subjects who are not willing to participate Study subjects who are consuming alcohol Study subjects who are unable to provide informed consent or receive counselling because of impaired mental status cognitive impairment or communicating barrier Study subjects if they had participated in other smoking cessation programs or services |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of behavior counselling using role modelling technique and video based tobacco cessation counselling among Paliyar tribes |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness of behavior counselling using role modelling technique among Paliyar tribes
|
1st months 3rd month 6th month |
| Effectiveness of video based tobacco cessation counselling among Paliyar tribes |
1st month 3rd month 6th month |
| Effectiveness of behavioral counselling using role modelling technique and video based tobacco cessation counselling among Paliyar tribes |
1st month 3rd month 6th month |
| Assess the tobacco dependence among Palliyar tribes |
1st month 3rd month 6th month |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2 |
|
Date of First Enrollment (India)
|
25/08/2024 |
| 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="9"
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
|
AIM To assess and compare the effectiveness of behavior counselling using role modelling technique and video based tobacco cessation counselling among Paliyar tribes RESEARCH QUESTION Is there a difference in the effectiveness of role model based behavior counselling and video based
tobacco cessation counselling among the adults of Paliyar Tribes after 6 months STUDY POPULATION
Tribal Population in Sirumalai hills SAMPLING PROCEDURE The subjects will be selected based on convenience sampling method The subjects will be randomly allocated into test group and control group based on simple random
sampling The subjects will be selected based on inclusion and exclusion criteria STUDY GROUPS The number of groups is 2 Specify the groups Test group Role Model based behavioral counselling
Control group-Video based behavior counselling SAMPLE SIZE Sample size is calculated using G POWER software version 3.1 A sample size of 68 will be collected based on 90 % power and 5 % alpha error METHODOLOGY/PROCEDURES
At baseline demographic characters and tobacco dependence will be analyzed by
Fagerstrom Nicotine dependency scale INTERVENTIONS FOR TEST GROUP AND CONTROL GROUP For test group Role model-based behavior counselling technique on tobacco cessation will be
given. A community leader/socially responsible person will be identified from the community based on
their reading and writing skills will be selected as role model. The Role model will be trained on behavior counselling technique on tobacco cessation by the
investigator. The Role model will be asked to counsel the study subjects on tobacco cessation .During every week the study subjects will be called and interviewed by the investigator. Daily follow up sessions will be done by the role model selected. For control group video based tobacco cessation counselling will be given. The study subjects will receive 4 videos. The video will be of 15 to 20 min of duration. In the video harmful effects of tobacco use, types of tobacco will be delivered, How the study
subjects will deal with difficult situations and attitudes toward smoking and quitting, how to cope
with negative moods with coping plans and how to deal with difficult risk situations .Every week phone interviewing will be done by the investigator. Interviewing will be conducted in the participants language of choice. Daily follow-up sessions will be done by the role model selected. |