| CTRI Number |
CTRI/2024/02/062373 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Warning labels in Tobacco counselling |
|
Scientific Title of Study
|
Knowledge , perception and quitting using graphic labels in tobacco cessation counselling among adult smokers - 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 |
Priya Ray |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Research Institute, Bangalore |
| Address |
Room no 9 , Department of Public Health Dentistry , Government Dental College and Research Institute , Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9674657769 |
| Fax |
|
| Email |
raypriya13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Shanbhag |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Research Institute, Bangalore |
| Address |
Room no 9 , Department of Public Health Dentistry , Government Dental College and Research Institute , Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9844072744 |
| Fax |
|
| Email |
drnamita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya Ray |
| Designation |
Post graduate student |
| Affiliation |
Government Dental College and Research Institute, Bangalore |
| Address |
Room no 9 , Department of Public Health Dentistry , Government Dental College and Research Institute , Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9674657769 |
| Fax |
|
| Email |
raypriya13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry, Government Dental College and Research Institute , Bangalore |
|
|
Primary Sponsor
|
| Name |
Priya Ray |
| Address |
Room no 9 , Department of Public Health Dentistry , Government Dental College and Research Institute , Bangalore |
| 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 |
| DrNamita Shanbhag |
Government dental college and research institute, Bengaluru |
Room no 9 , Department of Public Health Dentistry, Kalasipalya , Bengaluru -560002, Karnataka
Bangalore
KARNATAKA |
9844072744
drnamita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Government Dental College and Research Institute , Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional tobacco cessation counselling |
The participants will receive a standard brief motivational strategy based on the National Tobacco Dependance Treatment Guidelines at baseline , 4 weeks and 12 weeks and will be assessed with a standard pre validated questionnaire. To validate the effects on the actual smoking behaviour , the expired breath carbon monoxide will be assessed at the beginning of each visit . |
| Intervention |
Graphic warning labels |
Administering graphic health warnings along with standard tobacco cessation counselling. The participants will be assessed at baseline , 4 weeks and 12 weeks with a standard pre validated questionnaire. To validate the effects of the intervention on actual smoking behaviour we will measure expired breath carbon monoxide at the beginning of each visit . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged 18-60 years with history of smoking more than equal to 100 cigarettes during their lifetime and now smoking everyday or some days |
|
| ExclusionCriteria |
| Details |
1. Subjects who consume smokeless tobacco products
2. Subjects who received tobacco cessation counselling previously
3. Subjects who are currently using pharmacotherapy and NRT for smoking cessation |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Smoking status
Knowledge , perception and quit intentions
Breath carbon monoxide levels |
baseline , 4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Warning credibility
Label memory |
baseline , 4 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2024 |
| 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="0"
Months="3"
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
|
The tobacco epidemic is one of the biggest public health threats the world has ever faced killing over 8 million people a year around the world . Graphic warning labels are amongst the most cost-effective policy interventions to communicate health information as they draw smokers’ attention and elicit negative feelings and thoughts about tobacco use. The study will be conducted to determine the effectiveness of graphic warning labels on cigarette packs in tobacco cessation counselling in improving knowledge , perceptions and quit intention among adult subjects .Subjects will be shown graphic health warnings at baseline , 4 weeks and 12 weeks . Assessment of smoking status and knowledge , perception and quit intentions of the subjects will be done at baseline , 4 weeks and 12 weeks . |