| CTRI Number |
CTRI/2025/10/095830 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Helping communities and youth say no to tobacco in south India |
|
Scientific Title of Study
|
Youth organized urban, rural tobacco harm- prevention: integrated mentorship, peer advocacy and community training- a cluster randomized trail to reduce susceptibility to tobacco from south India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveena S |
| Designation |
Post graduate |
| Affiliation |
Sri lakshmi narayana institute of medical sciences |
| Address |
Sri lakshmi narayana institute of medical sciences, department of community medicine, osudu, agaram village ,villianur commune, kudapakkam post, puducherry
Pondicherry
PONDICHERRY
605502
India |
| Phone |
8300077677 |
| Fax |
|
| Email |
pravishan13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Praveena S |
| Designation |
Post graduate |
| Affiliation |
Sri lakshmi narayana institute of medical sciences |
| Address |
Sri lakshmi narayana institute of medical sciences, osudu, agaram village ,villianur commune, kudapakkam post, puducherry
Pondicherry
PONDICHERRY
605502
India |
| Phone |
8300077677 |
| Fax |
|
| Email |
pravishan13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveena S |
| Designation |
Post graduate |
| Affiliation |
Sri lakshmi narayana institute of medical sciences |
| Address |
Sri lakshmi narayana institute of medical sciences, osudu, agaram village ,villianur commune, kudapakkam post, puducherry
Pondicherry
PONDICHERRY
605502
India |
| Phone |
8300077677 |
| Fax |
|
| Email |
pravishan13@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri lakshmi narayana institute of medical sciences |
| Address |
Sri lakshmi narayana institute of medical sciences, osudu, agaram village, villianur commune, kudapakkam post, puducherry- 605502 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Praveena S |
Puducherry |
Sri lakshmi narayana institute of medical sciences, osudu, agaram village ,villianur commune, kudapakkam post, puducherry
Pondicherry
PONDICHERRY |
08300077677
pravishan13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
College students 18 to 20 years of age those who have never consumed tobacco. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peer Educator Training , follow up , assessment. |
Intensive 2-day workshop covering tobacco harms, communication strategies, group facilitation, and confidentiality
Ongoing mentorship and support from PG researcher and faculty advisor
|
| Comparator Agent |
Standard health education |
receive standard health education materials (e.g., pamphlets, posters) about tobacco risks, as per existing campus policy based on cessation strategy of Govt of India |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Young adults aged 18–20 years residing in selected urban or rural colleges. Never users of tobacco and susceptible to future tobacco use. Willing to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
Current or former users of any tobacco product. Individuals with serious mental illness (referral services for consultation, rehabilitation and cessation modules at SLIMS).Unwilling to consent |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in susceptibility to tobacco use. |
Immediate and after 2 weeks of intervention will look for well received or not. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in awareness of the harm of tobacco and look over refusal skills , health consequences , reflection and commitment to continue to decrease susceptibility of tobacco usage. |
six month and one year |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
13/02/2026 |
| 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="6"
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
|
The study titled Young Organized Urban/Rural Tobacco Harm-Prevention: Integrated Mentorship, Peer Advocacy and Community Training (YOUTH-IMPACT) is a cluster randomized trial conducted among college students in Puducherry and nearby Villupuram districts. It aims to evaluate the effectiveness of a peer-led, digitally supported intervention in reducing susceptibility to tobacco use among young adults aged 18–20 years. The study includes 20 colleges (10 per arm) with a total sample size of 1,200 students. The intervention group receives a 12-week digital module via WhatsApp, consisting of short videos, infographics, polls, and discussions facilitated by trained peer leaders, while the control group receives standard health education materials. Data will be collected at baseline, immediately after the intervention, and at 6 and 12 month follow ups. Statistical analysis includes descriptive, bivariate, and multivariate regression models to assess behavioral and attitudinal changes. The primary outcome is a reduction in susceptibility to tobacco use, while secondary outcomes include changes in knowledge, attitudes, perceived norms, and digital engagement. The study ensures ethical standards through informed consent and confidentiality, and offers the intervention to control colleges after completion. This project aims to develop a scalable, culturally relevant model for youth tobacco prevention in South India. |