| CTRI Number |
CTRI/2024/02/062674 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Behavioral Interventions (Breathing exercises) and Self- help to Quit Smoking Tobacco Habits in Engineering Students of Lucknow City- A Field Trial |
|
Scientific Title of Study
|
"Comparative Evaluation of Behavioral Interventions to restrain Smoking Tobacco Habits In Engineering Students of Lucknow City- A Field Trial" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Aparna Chaturvedi |
| Designation |
Post Graduate Resident |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow |
| Address |
Department NO. 9 Department of Public Health Dentistry
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8840869102 |
| Fax |
|
| Email |
aparna.phd@sppgidms.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pooja M. Sinha |
| Designation |
Professor |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow |
| Address |
Department NO. 9 Department of Public Health Dentistry
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9453014043 |
| Fax |
|
| Email |
dr.pujasinha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Aparna Chaturvedi |
| Designation |
Post Graduate Resident |
| Affiliation |
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow |
| Address |
Department NO. 9 Department of Public Health Dentistry
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8840869102 |
| Fax |
|
| Email |
aparna.phd@sppgidms.org |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Chaturvedi |
| Address |
Department NO. 9 Department of Public Health Dentistry
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow |
| Type of Sponsor |
Other [Self Funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aparna Chaturvedi |
Dental college |
Department of Public Health Dentistry Room NO. 9 Sardar Patel Post Graduate Institute of Dental and Medical Sciences , Raebareli road , Utrathia, Vrindavan colony, Lucknow 226025
Lucknow
UTTAR PRADESH |
8840869102
aparna.phd@sppgidms.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Smoking Tobacco Habits |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavior Modification |
Behavior Modification Techniques to restrain Smoking Tobacco Habits like Breathing Exercises
Duration- 9 months |
| Comparator Agent |
Self Help |
Self Help to restrain Smoking Tobacco Habits
Duration- 9 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants those who will give consent.
2. Subjects who are 20 to 21 years of age, and current smokers with only tobacco smoking history of at least 6 months with low level of dependence- Those who neither use tobacco before 30 minutes of waking up nor use it more than 25 times a day.
3. Subjects with “readiness to quit†state of mind.
|
|
| ExclusionCriteria |
| Details |
1. Subjects that are current pharmacological use to quit smoking.
2. Subjects with the presence of Pre -Malignant Lesions
3. Subjects with the presence of any systemic disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate which method has better effectiveness to restrain tobacco habits
|
at baseline 3 months 6 months 9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the effectiveness of education programs for smoking cessation in engineering students.
To Compare the effectiveness of behavioral intervention programs & self-help programs among engineering students.
To educate the study subjects about the adverse effect of tobacco smoking.
|
At baseline 3 months 6 months 9 months |
|
|
Target Sample Size
|
Total Sample Size="318"
Sample Size from India="318"
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)
|
30/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Tobacco
consumption is a major public health concern all across the globe. Cigarette
smoking is one of the major types of tobacco consumption seen worldwide. It
contains the highest number of carcinogens and is associated with various forms
of cancer. The initiation of smoking is a cause of addiction, leading to greater
harm in the younger population and give rise to increased severity and reduced
efforts to seek treatment for tobacco use. Hence,
the present field trial is aimed to evaluate as well as compare the
effectiveness of behavioral intervention (incorporating exercise) in one group
and educational intervention (self-help) in second group to focus on early
cessation of the smoked tobacco habit to prevent the harmful effects of the
same and improve the quality of life before a person becomes dependent on it. |