| CTRI Number |
CTRI/2025/05/086257 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess a family-focussed approach for assisting indigenous
tobacco users in Assam, Nagaland, and Andhra Pradesh in quitting tobacco, and examining its practicality across various locations. |
|
Scientific Title of Study
|
Family-centered tobacco cessation intervention among indigenous tobacco users in Assam, Nagaland and Andhra Pradesh: Multi-centre feasibility study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Limalemla Jamir |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Guwahati |
| Address |
Department of Community and Family Medicine, AIIMS, Guwahati, Changsari, Kamrup, Assam
Kamrup
ASSAM
781101
India |
| Phone |
9914104152 |
| Fax |
|
| Email |
limajamir@aiimsguwahati.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Limalemla Jamir |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Guwahati |
| Address |
Department of Community and Family Medicine, AIIMS, Guwahati, Changsari, Kamrup, Assam
ASSAM
781101
India |
| Phone |
9914104152 |
| Fax |
|
| Email |
limajamir@aiimsguwahati.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Limalemla Jamir |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Guwahati |
| Address |
Department of Community and Family Medicine, AIIMS, Guwahati, Changsari, Kamrup, Assam
ASSAM
781101
India |
| Phone |
9914104152 |
| Fax |
|
| Email |
limajamir@aiimsguwahati.ac.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O.Box No.4911, Ansari
Nagar, New Delhi-110029, India
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Limalemla Jamir |
All India Institute of Medical Sciences (AIIMS) Guwahati |
Department of Community and Family Medicine
Kamrup
ASSAM |
9914104152
limajamir@aiimsguwahati.ac.in |
| Dr Rajeev Aravindakshan |
All India Institute of Medical Sciences (AIIMS) Mangalagiri |
Department of Community and Family Medicine
Guntur
ANDHRA PRADESH |
8075646314
rajeev.a@aiimsmangalagiri.edu.in |
| Dr Vizovonuo Visi |
Nagaland Institute of Medical Sciences and Research (NIMSR) |
Department of Community Medicine
Kohima
NAGALAND |
9612428993
vizovisi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences (AIIMS), Mangalgiri, Andhra Pradesh |
Approved |
| All India Institute of Medical Sciences (AIIMS),Guwahati, Changsari,781101 Assam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Tobacco users |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator |
Standard care |
| Intervention |
Intervention |
A family- focussed tobacco cessation module will be developed. This will comprise individual and family level intervention strategies. Weekly sessions for participants and their families will be held separately or together based on the theme in the module, for a total period of 12 weeks, 60 minutes per session. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Adults age 18 years and above; all genders; upto two family members currently using tobacco in any form for the last one month; willing to attend all tobacco cessation sessions |
|
| ExclusionCriteria |
| Details |
Major medical morbidities; other illicit substance use |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recruitment rate, retention rate, acceptability, fidelity, adaptation needs, completeness, tobacco use pre- and post-intervention, quit rates, relapse rate |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barriers and facilitators, tobacco usage patterns |
3 years |
|
|
Target Sample Size
|
Total Sample Size="486"
Sample Size from India="486"
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)
|
20/05/2025 |
| 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="3"
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
|
The primary objective of this study is to determine whether a family-centered, peer-delivered tobacco cessation intervention can be feasibly implemented in the states of Assam, Nagaland, and Andhra Pradesh, which represent diverse cultural and tobacco-use profiles within India. This approach emphasizes the active involvement of family members and utilizes peer support to encourage and sustain tobacco cessation efforts, recognizing the influential role that close social networks play in shaping health behaviors. Secondary objectives of the study involve systematically measuring the prevalence of tobacco use before and after the intervention, thereby providing quantitative evidence of the intervention’s impact on tobacco use within households. Additionally, the study seeks to identify the main barriers and facilitators in tobacco cessation. By addressing these objectives, the study aims to generate actionable insights into how family and peer dynamics can be harnessed to improve tobacco cessation outcomes, and to inform the design of scalable, context-sensitive interventions that could be adopted in similar settings across India. |