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

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.