| CTRI Number |
CTRI/2017/05/008681 [Registered on: 26/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Pre Test and Post Test |
| Study Design |
Other |
|
Public Title of Study
|
Study of Increasing Stoppage of smoking among college students |
|
Scientific Title of Study
|
Increasing Smoking Cessation Care among College Students: An Implementation study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amrut Kore |
| Designation |
Post Graduate Student |
| Affiliation |
Deparment of Public Heath, Manipal University |
| Address |
Department of Public Health
Old Tapme Building
Manipal University Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7406338616 |
| Fax |
|
| Email |
dr.amrutkore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manthan Janodia |
| Designation |
Associate Professor |
| Affiliation |
Rank1st among private pharmacy institutions in the country |
| Address |
Manipal college of Pharmaceutical Sciences. department of Pharmacology 1st floor Manipal University Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9880130878 |
| Fax |
|
| Email |
manthan.janodia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrut Kore |
| Designation |
Post Graduate Student |
| Affiliation |
Deparment of Public Heath, Manipal University |
| Address |
Department of Public Health
Old Tapme Building
Manipal University Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7406338616 |
| Fax |
|
| Email |
dr.amrutkore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Madhav Nagar Manipal University Manipal 576104 Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Amrut Kore |
| Address |
Department of Public Health,
Old Tapme Building,
Manipal University, Manipal
|
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Amrut Kore |
Kasturba Hospital Manipal |
Department of Public Heath
Old Tapme Building 2nd Floor
Manipal University Manipal
Udupi
KARNATAKA |
7406338616
dr.amrutkore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Hospital,Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
College students with no disease condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
educational materials |
educational materials like videos and text messaging relating to the benefits of stopping tobacco.
duration 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Students above 18 years of age and who can read write and understand English as a language |
|
| ExclusionCriteria |
| Details |
Students who don’t understand English as a language and who is not willing to take part in the study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improve Knowledge Attitude Perception towards ill effects of Tobacco usage.
|
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase awareness on harmful affects of Tobacco usage. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Smoking is harmful because there are many ingredients in tobacco smoke that can harm your body.The main health risks from smoking are lung cancer, heart disease and stroke. Smoking causes almost 90% of deaths from lung cancer, around 80% of deaths from COPD, and around 17% of deaths from heart disease. While tobacco use is decreasing in many developed countries. it is increasing in developing countries such as India, As per the latest nationally representative Global Adult Tobacco Survey (GATS). India had 275 million current tobacco users in the year 2009-2010 (over 35 % of adults): majority of them used smokeless tobacco (164 million) and 42 million used both forms of tobacco. An estimated one million people die every year due to tobacco related diseases in India. In order to reduce the impact of tobacco related morbidity and mortality, we need a combination of strategies aimed at avoiding initiation of tobacco by the non-users and cessation of tobacco use among current users. |