| CTRI Number |
CTRI/2014/03/004458 [Registered on: 10/03/2014] Trial Registered Prospectively |
| Last Modified On: |
25/07/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Reducing tobacco use among women in self-help groups (SHGs) in Gadchiroli district, Maharashtra through a follow-up community-based tobacco cessation intervention package which will reinforce the tobacco cessation and awareness about tobacco achieved in an earlier intervention among these women. |
|
Scientific Title of Study
|
Effect of a longitudinal community-based tobacco cessation intervention package on tobacco use among women in self-help groups (SHGs) in Gadchiroli district, Maharashtra, India |
| 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 Bang MD MPH |
| 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@sify.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Bang MD MPH |
| 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@sify.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Bang MD MPH |
| 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@sify.com |
|
|
Source of Monetary or Material Support
|
| Mahila Arthik Vikas Mahamandal (Women Economic Development Corporation), Gadchiroli, Maharashtra, India |
|
|
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 organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mahila Arthik Vikas Mahamandal Women Economic Development Corporation |
Gadchiroli, Maharashtra, India |
|
|
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, Maharashtra, India |
Shodhgram
PO and District Gadchiroli
Maharashtra, India 442605
Gadchiroli
MAHARASHTRA |
91-07138-255407
91-07138-255411
search@sify.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, SEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tobacco use, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
community-based tobacco
cessation intervention package |
The women members of SHG members of Mahila Arthik Vikas Mahamandal (MAVIM) will receive the tobacco cessation intervention package over a period of 4 months. The intervention package will include- i) group health education for tobacco cessation of all the women SHG members in the village by a trained supervisor(once during the intervention period), ii) individual counseling of tobacco users through home visits (once every month for 4 months) , iii) oral evaluation to assess oral lesions due to tobacco by dentists (once during the intervention period), iv) showing health education videos on the ill effects of tobacco (once during the intervention period) and v) distributing earthen money saving pots to save money that would otherwise be spent on tobacco (once at the beginning of the intervention). |
| Comparator Agent |
This will be a before-and-after intervention comparison |
We will compare the primary and secondary outcomes before and after the intervention among the SHG members |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Cluster level:
Inclusion criteria: The cluster
1. should belong to the Mahila Arthik Vikas Mahamandal (MAVIM)
2. should be in Gadchiroli district
3. office should be less than 50 km from the SEARCH headquarter
4. should have at least 4 functioning Sahayoginis (supervisors)
5. should have received the first round of community-based intervention package for tobacco cessation designed by SEARCH
Individual level:
1. the woman should be a member of the MAVIM SHG in the village from selected clusters
2. the SHG members should be more than 18 years old
|
|
| ExclusionCriteria |
| Details |
Cluster level:
1. Clusters with more than 20 percent tribal villages (as the health education material was designed considering non-tribal population)
Individual level:
1. if the woman SHG member is bedridden due to illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the percentage of SHG members using tobacco |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in the average daily expenditure on tobacco |
4 months |
| The amount of money saved in the earthen money saving pots by the tobacco users |
4 months |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2014 |
| 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 will assess the effect of a longitudinal community-based tobacco cessation intervention package on tobacco use among women microfinance self-help group (SHG) members. The study will be conducted in the three field clusters of Mahila Arthik Vikas Mahamandal (MAVIM), which have received the first round of the community-based tobacco cessation intervention package, in Gadchiroli district, Maharashtra, India . The intervention package will include- i) group health education meetings for women SHG members conducted by a trained supervisors (Sahayoginis), ii) home visits by a trained SHG member (designated as a Muktidoot) for individual counseling of women SHG members for tobacco cessation, iii) oral checkup of SHG members by dentists to diagnose oral ill effects of tobacco and provide referral and counseling, iv) showing health educational videos on the ill effects of tobacco and v) distribution of earthen money saving pot to save money spent on tobacco. The intervention package will be implemented for 4 months among the selected MAVIM clusters. The primary outcome will be decrease in the percentage of SHG members using tobacco and the secondary outcomes will be-a) Decrease in the average daily expenditure on tobacco and b) the amount of money saved in the earthen money saving pots by the tobacco users during the intervention. The primary and the secondary outcomes will be assessed by the SHG members using a standardized questionnaire at baseline and at the end of 4 months of the intervention. Tobacco use will be assessed using the self-report method and 10 % of those who report quitting tobacco at the end of the intervention will undergo objective assessment using salivary cotinine testing. |