| CTRI Number |
CTRI/2015/10/006233 [Registered on: 05/10/2015] Trial Registered Prospectively |
| Last Modified On: |
22/03/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
How to reduce tobacco use among school children? A cluster randomised controlled trial in Gadchiroli, Maharashtra |
Scientific Title of Study
Modification(s)
|
How to reduce tobacco use among school children? A cluster randomised controlled trial in Gadchiroli, Maharashtra |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay T Bang |
| Designation |
Director, SEARCH |
| Affiliation |
SEARCH |
| Address |
Shodhgram,
PO and District Gadchiroli
Gadchiroli
MAHARASHTRA
442605
India |
| Phone |
91-07138-255407 |
| Fax |
91-07138-255411 |
| Email |
search.gad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay T Bang |
| Designation |
Director, SEARCH |
| Affiliation |
SEARCH |
| Address |
Shodhgram,
PO and District Gadchiroli
Gadchiroli
MAHARASHTRA
442605
India |
| Phone |
91-07138-255407 |
| Fax |
91-07138-255411 |
| Email |
search.gad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Bang |
| Designation |
Director, SEARCH |
| Affiliation |
SEARCH |
| Address |
Shodhgram,
PO and District Gadchiroli
Gadchiroli
MAHARASHTRA
442605
India |
| Phone |
91-07138-255407 |
| Fax |
91-07138-255411 |
| Email |
search.gad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Navajbai Ratan Tata Trust |
|
|
Primary Sponsor
|
| Name |
Society for Education Action and Research in Community Health SEARCH |
| Address |
Shodhgram
PO and District Gadchiroli Maharashtra, India 442605
|
| Type of Sponsor |
Other [Non-Governmental Organisation] |
|
|
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 Abhay Bang MD MPH |
Gadchiroli |
SEARCH, Gadchiroli, Maharashtra, India
Gadchiroli
MAHARASHTRA |
91-07138-255407
91-07138-255411
search.gad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SEARCH Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tobacco use, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control arm |
The schools in control arm will receive the activities conducted by the District Tobacco Control Cell (DTCC) under the National Tobacco Control Programme. |
| Intervention |
School-based tobacco awareness and control intervention |
The intervention will include- i) Oral examination by a dentist and counseling to quit tobacco, ii) School-level activities by the anti-tobacco committee of the school to increase awareness about the harmful effects of tobacco among school students through poster and elocution competitions and monitoring the use of tobacco products on the school campus iii) Group-level activities for selected standards with support group formation and peer-led discussion on normative beliefs, healthy lifestyle and methods to quit tobacco, and iv) Increasing awareness about the Cigarette and Other Tobacco Products Act (COTPA) among school authorities and promoting its implementation in the schools. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Cluster/School level:
1. The primary and secondary Marathi schools in the Gadchiroli and Dhanora block of Gadchiroli district
2. The schools should provide written consent for the participation in study.
3. The schools should be located within 50 kilometers of the campus of SEARCH
Individual/student level:
1. Children studying in 5th to 10th Standard among selected schools
2. Should providing assent for participation in the group level activities under the intervention
|
|
| ExclusionCriteria |
| Details |
Cluster level:
1. Schools with less than 50 students on roll
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the prevalence of self-reported use of tobacco among students from the schools receiving intervention compared to the schools in the control arm at the end of the school-based tobacco awareness and cessation intervention programme |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the self-reported frequency of daily tobacco use among tobacco users |
4 months |
| Increase in the awareness about tobacco and its harmful effects among students as determined by the listing of 5 appropriate harmful effects by the students |
4 months |
| Improvement in the tobacco refusal intention among students in intervention arm compared to those in the control arm. This will be assessed by the response to the question- “will you accept tobacco if your friends offer it to you?†|
4 months |
|
|
Target Sample Size
|
Total Sample Size="1650"
Sample Size from India="1650"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/10/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a cluster randomized, parallel group, two arm controlled trial to assess the effectiveness of a school-based tobacco awareness and cessation programme on tobacco use among school children in Gadchiroli, Maharashtra, India. The study will be conducted in the selected 50 schools of Dhanora and Gadchiroli blocks of Gadchiroli district. The tobacco cessation intervention package will target children studying in 5th to 10th standard of primary and secondary Marathi schools of the above two blocks. The intervention will include- i) Oral examination by a dentist and counseling to quit tobacco, ii) School-level activities by the anti-tobacco committee of the school to increase awareness about the harmful effects of tobacco among school students through poster and elocution competitions and monitoring the use of tobacco products on the school campus iii) Group-level activities for selected standards with support group formation and peer-led discussion on normative beliefs, healthy lifestyle and methods to quit tobacco, and iv) Increasing awareness about the Cigarette and Other Tobacco Products Act (COTPA) among school authorities and promoting its implementation in the schools. The intervention package will be implemented for 4 months among 25 schools in the intervention arm. The primary outcome will be reduction in the prevalence of self-reported use of tobacco use among students from schools in the intervention arm compared to the schools in the control arm at the end of the intervention. The secondary outcomes will be reduction in the daily frequency of tobacco use, increase in the awareness of harmful effects of tobacco and improvement in tobacco refusal intention in the intervention arm compared to the control arm. If the intervention is found to be effective it will be implemented in schools of the control arm. |