| CTRI Number |
CTRI/2012/12/003262 [Registered on: 26/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
15/09/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Community based tobacco cessation intervention package] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Empowering women in self-help groups (SHGs) in Gadchiroli district, Maharashtra to reduce tobacco consumption and increase savings by a community-based tobacco cessation intervention package |
|
Scientific Title of Study
|
A controlled field trial to assess the effect of a community-based tobacco cessation intervention package on tobacco use and expenditure on tobacco in women self-help group members in rural Gadchiroli, Maharashtra, India: The Women’s Empowerment through Liberation From Tobacco (WE LiFT) project |
| Trial Acronym |
WE LiFT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay Bang |
| Designation |
Director, SEARCH |
| Affiliation |
Society for Education, Action and Research in Community Health |
| Address |
SEARCH, Shodhgram
PO and District Gadchiroli
Gadchiroli
MAHARASHTRA
442605
India |
| Phone |
07138-255407 |
| Fax |
07138-255411 |
| Email |
search@sify.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Bang |
| Designation |
Director, SEARCH |
| Affiliation |
Society for Education, Action and Research in Community Health |
| Address |
SEARCH, Shodhgram
PO and District Gadchiroli
Gadchiroli
MAHARASHTRA
442605
India |
| Phone |
07138-255407 |
| Fax |
07138-255411 |
| Email |
search@sify.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Bang |
| Designation |
Director, SEARCH |
| Affiliation |
Society for Education, Action and Research in Community Health |
| Address |
SEARCH, Shodhgram
PO and District Gadchiroli
Gadchiroli
MAHARASHTRA
442605
India |
| Phone |
07138-255407 |
| Fax |
07138-255411 |
| Email |
search@sify.com |
|
|
Source of Monetary or Material Support
|
| Indira foundation, Greenwich, CT, USA |
| Mahila Arthik Vikas Mahamandal (Women Economic Development Corporation), Gadchiroli, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Society for Education Action and Research in Community Health |
| Address |
Shodhgram
PO and District Gadchiroli
Maharashtra, India 442605
|
| Type of Sponsor |
Other [Non-governmental organisation] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mahila Arthik Vikas Mahamandal |
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 |
Gadchiroli |
SEARCH, Shodhgram
Gadchiroli
MAHARASHTRA |
07138-255407
search@sify.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 |
| Intervention |
Community-based tobacco cessation intervention package for women SHG members (Intervention arm 1) |
Here, the women members of SHGs of MAVIM will receive the tobacco cessation intervention package which will include group health education, individual counseling of users, distribution of earthen saving pots to save money spent on tobacco, oral evaluation by dentists to assess oral lesions due to tobacco and distribution of iron and folic acid (ferrous sulphate 300mg and folic acid 0.5 mg- one tablet once a week by mouth for 7 months), B-complex vitamin tablets (1 tablet twice daily by mouth for 7 days) and calcium tablets (calcium lactate 300 mg, one tablet twice daily by mouth for 7 days) as a health promotion measure and bisacodyl tablets (5mg tablet, one tablet at bed time for 7 days) for those reporting using tobacco to prevent constipation |
| Intervention |
Community-based tobacco cessation intervention package for women SHG members and their husbands (Intervention arm 2) |
Here the SHG members and their husbands will receive the tobacco cessation intervention package as described in intervention arm 1. |
| Comparator Agent |
No intervention |
In the comparison cluster, the community-based tobacco intervention package will not be provided |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Cluster level:
1. should belong to the Mahila Arthik Vikas Mahamandal
2. should be in Gadchiroli district
3. office should be 50 km or less from the SEARCH headquarter
4. should have at least 4 functioning Sahayoginis (assistants)
Individual level:
1. the woman should be a member of the MAVIM SHG in the village from selected clusters
2. in the cluster where men will also receive the intervention, the man should be the husband of a women member of MAVIM SHG in the village
3. the SHG members and their husbands should be 18-90 years old
|
|
| ExclusionCriteria |
| Details |
Cluster level:
1.Clusters with >20% tribal villages (as health education material was designed considering non-tribal population)
Individual level:
1.if the woman SHG member or the husband of the member is bedridden due to illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in the percentage of SHG members using tobacco |
7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in the average daily expenditure on tobacco |
7 months |
| The amount of money saved in the earthen money saving pots by the families of the tobacco users in the intervention areas |
7 months |
| Decrease in the percentage of family members of the self-help group members using tobacco |
7 months |
| Increase in the percentage of self-help group members and their husbands with a sense of wellbeing |
7 months |
| Decrease in the percentage of self-help group members and their husbands with oral discomfort |
7 months |
|
|
Target Sample Size
|
Total Sample Size="2400"
Sample Size from India="2400"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/10/2012 |
| 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="10"
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 group randomized, parallel group, multiple arm field trial to assess the effectiveness of a community-based tobacco cessation intervention package on tobacco use and expenditure on tobacco among women microfinance self-help group (SHG) members. The study will be conducted in the selected field clusters of Mahila Arthik Vikas Mahamandal (MAVIM), the state government’s women’s economic development agency, in Gadchiroli district, Maharashtra, India. The study will be conducted in 3 randomly selected field clusters of MAVIM from 11 existing clusters in the districts, selected based on inclusion and exclusion criteria. In one cluster (intervention arm 1), the tobacco cessation intervention package will target women SHG members of MAVIM. In the second cluster (intervention arm 2), the intervention will target SHG members and their husbands. A third cluster will act as a comparison cluster where no intervention will be provided. The intervention package will include- i) health education through participatory group meetings for women SHG members conducted by a trained SHG member (designated as a Muktidoot), ii) home visits by the Muktidoots for individual counseling of women SHG members (and their husbands in intervention arm 2) who use tobacco, iii) distribution of earthen saving pots by the Muktidoots to the SHG members (and their husbands in intervention arm 2) who use tobacco to save money spent on tobacco, iv) oral checkup of SHG members (and their husbands in intervention arm 2) who use tobacco by dentists to diagnose oral ill effects of tobacco and provide referral, v) distribution of vitamin, iron and calcium supplements as a health promotion measure to the women SHG members who use tobacco. The intervention package will be implemented for 7 months among all SHG members in the intervention 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, b) The amount of money saved in the earthen money saving pots by the SHG members (and their husbands in intervention arm 2) who use tobacco in the intervention areas, c) Decrease in the percentage of family members of the self-help group members using tobacco, d) Increase in the percentage of self-help group members (and their husbands in intervention arm 2) with a sense of wellbeing, e) Decrease in the percentage of individuals with oral discomfort. The primary and the secondary outcomes will be assessed on a subset of randomly selected SHG members (and their husbands) using a standardized questionnaire in the intervention and comparator arms at baseline and at the end of 7 months of the intervention. Tobacco use will be assessed using the self-report method and 25% of those who report quitting tobacco at the end of the intervention will undergo objective assessment using salivary cotinine testing. |