| CTRI Number |
CTRI/2025/11/098032 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study on weekly WhatsApp messages for adult tobacco users in Delhi. |
|
Scientific Title of Study
|
Effectiveness of mHealth intervention in tobacco users: a quasi-experimental 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 |
Dr Abhishek Gautam |
| Designation |
Postgraduate Resident (MD Community Medicine) |
| Affiliation |
Maulana Azad Medical College Delhi |
| Address |
Department of Community Medicine
third floor
Maulana Azad Medical College Bahadur Shah Zafar Marg
New Delhi – 110002
Central
DELHI
110002
India |
| Phone |
7011030092 |
| Fax |
|
| Email |
gabhishek350@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Rao |
| Designation |
Associate Professor (Community Medicine) |
| Affiliation |
Maulana Azad Medical College Delhi |
| Address |
Community Medicine Department
third floor Path block
Maulana Azad Medical College Delhi 2 BSZ Marg New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9650729724 |
| Fax |
|
| Email |
shivani.idsp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Rao |
| Designation |
Associate Professor (Community Medicine) |
| Affiliation |
Maulana Azad Medical College Delhi |
| Address |
Community Medicine Department
third floor Path block
Maulana Azad Medical College Delhi 2 BSZ Marg New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9650729724 |
| Fax |
|
| Email |
shivani.idsp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Abhishek Gautam |
| Address |
Department of Community Medicine
Maulana Azad Medical College,
2 B S Z Marg
New Delhi 110202 |
| Type of Sponsor |
Other [Individual] |
|
|
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 Abhishek Gautam |
Maulana Azad Medical College |
Department of Community Medicine
Third Floor
Maulana Azad Medical College
2 B S Z Marg New Delhi 110002
Central
DELHI |
7011030092
gabhishek350@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Z72.0 – Tobacco use |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General health education messages unrelated to tobacco |
After baseline counselling, participants receive weekly WhatsApp messages on general health topics such as nutrition, hygiene, exercise, and healthy lifestyle. One message is sent every Sunday morning for eleven weeks. These messages do not contain any tobacco-related content. Participants will receive these general health messages for a total duration of 12–14 weeks. |
| Intervention |
Mobile health (mHealth) behavior change intervention through weekly WhatsApp messages |
Participants will receive standardised face-to-face behaviour change counselling at baseline. This will be followed by weekly WhatsApp messages for eleven weeks. These messages provide tobacco-cessation information, health risks of tobacco, motivational content, and simple actionable tips. One message is sent every Sunday morning. Participants receive weekly tobacco-related messages through WhatsApp for a total duration of 12–14 weeks. Messages include text, images, and short videos in the local language. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Tobacco users who are residents of Gokalpuri for 6 months and will stay in Gokalpuri for at least another 4 months.
2. Access to a mobile phone (personal or shared family member mobile phone) capable of receiving WhatsApp messages.
3. Willingness to quit tobacco.
|
|
| ExclusionCriteria |
| Details |
1. Tobacco users already enrolled in tobacco de-addiction therapy.
2. Tobacco users with clinically diagnosed oral malignancy or any lung pathology requiring immediate medical consultation.
3. High dependence users with Fagerstrom score (7–10) will be excluded from the study.
4. Individuals who are not able to read, write and communicate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean quantity and mean frequency of tobacco use before and after intervention |
baseline and 12–14 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sociodemographic and behavioural factors associated with tobacco use.
(Behavioural factors include peer influence, family history of tobacco use, co-substance use, knowledge and attitudes towards tobacco, exposure to advertising, accessibility, age of initiation, social acceptability.) |
Baseline |
| Change in Mean Dependence Scores measured using Fagerstrom Test for Nicotine Dependence before and after intervention. |
Baseline and 12–14 weeks |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
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)
|
15/12/2025 |
| 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)
|
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
|
This study aims to evaluate the effectiveness of a mobile health intervention delivered through weekly WhatsApp messages for adult tobacco users living in an urban resettlement colony in Delhi. Tobacco use is a major public health issue in India and there is limited community level evidence on the usefulness of mobile based support for tobacco cessation. This quasi experimental study has two groups an intervention group and a control group. All participants will receive brief behaviour change counselling at baseline. The intervention group will receive weekly WhatsApp messages related to tobacco de addiction health information and motivation while the control group will receive weekly messages on general health topics that are not related to tobacco. The primary outcome is the change in quantity and frequency of tobacco use after twelve to fourteen weeks. Secondary outcomes include change in nicotine dependence scores and the sociodemographic and behavioural factors associated with tobacco use. The study will include adult tobacco users who are residents of Gokalpuri and have access to a mobile phone. Data will be collected at baseline and again at twelve to fourteen weeks to assess changes in tobacco use and dependence. The findings may help in planning community based mobile health interventions for tobacco cessation in resource limited settings. |