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Open Access Study protocol

Feasibility and pilot study of the effects of microfinance on mortality and nutrition in children under five amongst the very poor in India: study protocol for a cluster randomized controlled trial

Shalini Ojha1, Lisa Szatkowski2, Ranjeet Sinha3, Gil Yaron4, Andrew Fogarty2, Stephen Allen5, Sunil Choudhary6 and Alan R Smyth1*

Author Affiliations

1 Division of Child Health, Obstetrics and Gynaecology, University of Nottingham, Queen’s Medical Center, Derby Road, NG7 2UH Nottingham, UK

2 Division of Epidemiology and Public Health, University of Nottingham, Clinical Sciences, City Hospital, NG5 1 PB Nottingham, UK

3 Department of Community Medicine, Patna Medical College & Hospital, 800004 Patna, India

4 Chair of the Board of Trustees, Rojiroti UK, 32 Amenbury Lane, AL5 2DF Harpenden, UK

5 Pediatrics and International Health, College of Medicine, Room 314, The College of Medicine, Swansea University, SA2 8PP Swansea, UK

6 Secretary, CPSL, House No-22, R.L. Enclave, Duplex Colony, Near at Sonali Auto, Bye Pass Road, Vishnupuri, Anishabad, Patna 800002 Bihar, India

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Trials 2014, 15:298  doi:10.1186/1745-6215-15-298

Published: 23 July 2014

Abstract

Background

The United Nations Millennium Development Goals include targets for the health of children under five years old. Poor health is linked to poverty and microfinance initiatives are economic interventions that may improve health by breaking the cycle of poverty. However, there is a lack of reliable evidence to support this. In addition, microfinance schemes may have adverse effects on health, for example due to increased indebtedness. Rojiroti UK and the Centre for Promoting Sustainable Livelihood run an innovative microfinance scheme that provides microcredit via women’s self-help groups (SHGs). This pilot study, conducted in rural Bihar (India), will establish whether it is feasible to collect anthropometric and mortality data on children under five years old and to conduct a limited cluster randomized trial of the Rojiroti intervention.

Methods/Design

We have designed a cluster randomized trial in which participating tolas (small communities within villages) will be randomized to either receive early (SHGs and microfinance at baseline) or late intervention (SHGs and microfinance after 18 months). Using predesigned questionnaires, demographic, and mortality data for the last year and information about participating mothers and their children will be collected and the weight, height, and mid upper arm circumference (MUAC) of children will be measured at baseline and at 18 months. The late intervention group will establish SHGs and microfinance support at this point and data collection will be repeated at 36 months.

The primary outcome measure will be the mean weight for height z-score of children under five years old in the early and late intervention tolas at 18 months. Secondary outcome measures will be the mortality rate, mean weight for age, height for age, prevalence of underweight, stunting, and wasting among children under five years of age.

Discussion

Despite economic progress, marked inequalities in child health persist in India and Bihar is one of the worst affected states. There is a need to evaluate programs that may alleviate poverty and improve health. This study will help to inform the design of a definitive trial to determine if the Rojiroti scheme can improve the nutrition and survival of children under five years of age in deprived rural communities.

Trial registration

Clinicaltrials.gov (study ID: NCT01845545). Registered on 24 April 2013.

Keywords:
Malnutrition; Under five mortality rate; Microfinance; Cluster randomized control trials