| CTRI Number |
CTRI/2025/08/093296 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the Impact of a Brief Educational Intervention on Tobacco Cessation Among Adults in a Rural Community. |
|
Scientific Title of Study
|
Effectiveness of Brief Intervention for Tobacco Cessation Education (BITCE) among Tobacco Users in a Rural Community: A Quasi-experimental Study |
| Trial Acronym |
BITCE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen Kumar B A |
| Designation |
Professor |
| Affiliation |
PES Institute of Medical Sciences and Research |
| Address |
Professor,
Department of Community Medicine,
PES Institute of Medical Sciences and Research, Kuppam
Chittoor
ANDHRA PRADESH
517425
India |
| Phone |
9494071558 |
| Fax |
|
| Email |
drpraveenba@pesimsr.pes.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Kumar B A |
| Designation |
Professor |
| Affiliation |
PES Institute of Medical Sciences and Research |
| Address |
Professor,
Department of Community Medicine,
PES Institute of Medical Sciences and Research, Kuppam
ANDHRA PRADESH
517425
India |
| Phone |
9494071558 |
| Fax |
|
| Email |
drpraveenba@pesimsr.pes.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Kumar B A |
| Designation |
Professor |
| Affiliation |
PES Institute of Medical Sciences and Research |
| Address |
Professor,
Department of Community Medicine,
PES Institute of Medical Sciences and Research, Kuppam
ANDHRA PRADESH
517425
India |
| Phone |
9494071558 |
| Fax |
|
| Email |
drpraveenba@pesimsr.pes.edu |
|
|
Source of Monetary or Material Support
|
| Dr. NTR University of Health Sciences, Vijayawada-520008, AP. |
|
|
Primary Sponsor
|
| Name |
Dr. NTR University of Health Sciences |
| Address |
Near Siddhartha Medical College, Beside New Government General Hospital, near Ramavarappadu, Vijayawada - 520008, Andhra Pradesh. |
| Type of Sponsor |
Other [Public Health Sciences University] |
|
|
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 Praveen Kumar B A |
Rural Community of Kuppam Constituency |
Gudupalle Mandal, Rural Community of Kuppam Constituency, Chittoor District, Andhra Pradesh.
Chittoor
ANDHRA PRADESH |
9494071558
drpraveenba@pesimsr.pes.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Human Ethics Committee (HEC), PESIMSR, Kuppam |
Approved |
| Human Ethics Committee (HEC), PESIMSR, Kuppam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
F17. Mental and behavioural disorders due to use of tobacco. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behavioural |
Cognitive Behavioral therapy integrated with motivational therapy and relapse prevention therapy will be given for 7 to 8 sessions with a duration of 40 to 45 minutes each and there can be multiple reinforcement sessions followed according to need |
| Intervention |
Nicotine gums |
Nicotine replacement therapy will be given minimum of 6-12 weeks and can extend upto 6 months according to the need. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult men and women aged 18 years to 60 years residing in the region for at least a year
2. Participants diagnosed to be nicotine dependent as per ICD 11 criteria
3. Subjects with mild and moderate severity Fagerstrom Test
4. Willingness to reside in the area for the next two years and available for follow up |
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Bedridden patients and individuals with other mental illnesses
3. Individuals who are already seeking treatment for tobacco cessation
4. Individuals with other psychoactive drug use |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction or cessation of tobacco use among participants |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.Changes in Fagerström Nicotine Dependence scores from baseline to post-intervention.
.Barriers and challenges encountered during the implementation of BITCE in a rural community setting |
1 year |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
01/09/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study aims to assess the effectiveness of brief behavioral interventions and nicotine replacement therapy (BITCE) in helping tobacco users quit and sustain abstinence in a rural area of Kuppam, Andhra Pradesh. It is a community-based quasi-experimental study involving 400 adult participants selected via multistage random sampling. Participants aged 18-60 years with mild to moderate nicotine dependence (as assessed by ICD-11 and the Fagerström Test) will receive behavioral interventions using the NIMHANS 5A and 5R approach, along with nicotine replacement therapy. Interventions will be group-based and conducted at the panchayat level. Follow-ups will be conducted at regular intervals over one year. Statistical analysis will include paired t-tests and chi-square tests to compare outcomes before and after the intervention. Ethics approval has been obtained from the Human Ethics Committee and informed consent from the participants will be obtained. This study will evaluate the effectiveness of community-based brief interventions for tobacco cessation and identify implementation challenges at the grassroots level. It aligns with India’s vision for Amrit Kaal by addressing rural health burdens. By complementing initiatives like Nasha Mukth Bharat Abhiyaan, it will aid in strengthening the tobacco control framework.
|