A Feasibility and Pilot Study of the Effects of Microfinance on Under 5 Mortality and Nutrition, Amongst the Very Poor in India

Background Microfinance is a process whereby small loans are given to the poorest families in developing countries to help overcome short term economic shocks (natural disasters or ill health) or to make small investments to improve their standard of living (eg in livestock. Microfinance has been shown to contribute to reducing poverty (particularly of female participants) and to improve the health of village economies. The Rojiroti scheme of microfinance has been running in several impoverished states in Northern India for ten years. This low cost scheme has been active in the states of Bihar, Madhya Pradesh and Uttar Pradesh and serves much poorer beneficiaries than those reached by mainstream microfinance. It works through establishing self-help groups (predominantly women from scheduled castes). Initially the members of these groups contribute their own money - a very small sum per week. After 3-6 months they become eligible for emergency loans for medical emergencies and general purpose loans, for investment in livestock etc.. These loans are administered locally by the charity "Centre for Promoting Sustainable Livelihoods" (CPSL). Rojiroti UK have just received a grant from the Department for International Development (DfID) for a 3 year expansion of the Rojiroti programme. Most of the participants in the Rojiroti scheme live in rural hamlets or "tolas", comprising several hundred people who earn a living by share cropping, as tenant farmers.

The investigators will evaluate the feasibility of collecting mortality data (both directly in the tola and through registered deaths) and the feasibility of a village volunteer weighing children under five and recording their weights, along with other self-help group data. If data collection proves feasible, the investigators will conduct a pilot cluster randomised trial of immediate vs. delayed microfinance in 50 tolas in Bihar. Trial outcomes will be mortality and weight for age Z score, weight for height z-scores and mid upper arm circumference in children less than 5 years of age.

Main centres Rojiroti is already established in northern Indian provinces of Bihar, Madhya Pradesh and Uttar Pradesh. In this study, the investigators plan to enrol tolas from Bihar. In the feasibility study there will be 10 tolas in each arm. If the data reach acceptable standards of accuracy and completeness, the investigators will continue the study in a further 40 tolas in each arm (total 50 tolas per arm, 100 altogether). The data analysis will be undertaken in the School of Medicine, University of Nottingham.

Design A feasibility and pilot study for a cluster randomised controlled trial (RCT). The unit of randomisation is the tola. A control tola, paired with each intervention tola, will be randomly selected to have similar characteristics (size and agroeconomic zone) to the early intervention tola. The control tola will be at least 15km away from the intervention site (to avoid self-help groups being set up by word of mouth) but close enough to be practical for data collection. The control tola will receive the microfinance intervention 18 months after randomisation.

Selection and randomisation of intervention sites The investigators will select tolas in Bihar province for the feasibility study (10 intervention and 10 control). It is important to include the control tolas at the feasibility stage, as the investigators think the challenges to complete and accurate data collection will be greater in the control tolas. Pairs of tolas will be selected by CPSL and the details provided to the team at the University of Nottingham in a secure, password protected spreadsheet, with each tola identified by a code number. The Nottingham team will randomise one of each pair to intervention or control group. Randomisation will be stratified by agroeconomic region (low, moderate and heavy annual rainfall).