A feasibility and pilot study of the effects of Rojiroti microfinance on the health and nutrition of children under five in Bihar, northern India

Lead Research Organisation: University of Nottingham
Department Name: School of Medicine

Abstract

Every year, 2.2 million children die of malnutrition. Many more have their life chances restricted because of the effects of malnutrition on their health and intellect. Different programmes have been tried to combat malnutrition in children. These include distributing food directly; giving children micronutrients (eg vitamins and zinc); employing community workers to give nutritional advice; and health interventions which protect children against the consequences of malnutrition (eg immunisation against measles). Research by bodies such as the World Health Organisation (WHO) has shown that these strategies can lead to better nourished children. However, when these approaches are used in a large scale (eg a whole country) they sometimes fail to reach those most in need (those living in extreme poverty). To help the greatest number of children, we must choose approaches which are cost effective and which can be sustained in the long term.
We are a group of community workers, scientists, economists and doctors. Our partners are the Centre for Promoting Sustainable Livelihood (CPSL) - which is a non-governmental organisation in India: a UK charity (Rojiroti UK); Patna Medical College India; and two UK academic partners (the University of Nottingham and the Liverpool School of Tropical Medicine). Our team have experience of helping very poor people in rural areas of India to fight poverty. Our community workers encourage people in poor hamlets or "tolas" in northern India to form self help groups (SHGs). Most SHGs are formed by women. They are asked to save a little money regularly, initially Rs2.5 (3 pence) per week. If they save regularly, their savings entitle them to a loan. These loans start small - Rs50 (50 pence). Women in the group can receive external loans (from CPSL) of Rs500 (£5) after 3 months and Rs3,000 (£30) after 6 months (if credit is good). Loans may be used for emergencies (eg medical expenses); to allow women access existing government support sches (eg money to travel to subsidised food shops); or to invest in livestock or agricultural equipment. Using these loans helps women avoid local money lenders (who charge much higher interest) and avoid emergency sales of their property (at knock down prices). We call this programme Rojiroti (which translates as "Livelihood").

We want to see if we can test whether Rojiroti improves children's health, using a test called a "cluster randomised controlled trial". We don't yet have all the information we need to design such a trial so we will first do a feasibility and pilot study. We will start by checking the feasibility of things like consent, weighing and measuring children, collecting data accurately and keeping track of participants in the trial. We will run a small version of the trial (called a pilot study) so that we have some preliminary data on children's nutrition. We think a key measure of the effectiveness of Rojiroti will be the children's weight corrected for height. This is called the weight for height Z score (WHZ). However, we will also record other measures of nutrition. We need preliminary data to work out how many tolas we will need for the definitive trial to test the effect (if any) of Rojiroti on children's nutrition. In our pilot study, half the tolas will get Rojiroti immediately and half will get it after 18 months. Which group gets Rojiroti immediately will be decided at random. We will weigh and measure children at the beginning and again after 18 months. We will compare the two groups to see if Rojiroti makes a difference to children's nutrition. We do not expect to be able to show a difference in our pilot study. However, once we have done the pilot study, we will know how many tolas we would need for a full trial which would answer the question. This means we can work out how many staff we will need and what the trial will cost. We can then make a funding application which will have all the necessary details.

Technical Summary

Every year 2.2 million children die of malnutrition and conventional strategies fail to reach those most in need. We will investigate a complementary approach - Rojiroti microfinance. This innovative scheme, for the very poor, has been delivered by the Centre for Promoting Sustainable Livelihood, in Northern India, since 2001. There are now over 50,000 members (mostly women). SHG members take out small loans to cope with emergencies, avoiding high interest lenders and forced asset sales. There is, as yet, no robust evidence that Rojiroti microfinance benefits child nutrition.

We will evaluate the feasibility of a cluster randomised trial of Rojiroti microfinance, amongst very poor women in Bihar, India. The unit of randomisation will be the "tola" (around 100 people). We will measure nutrition in children under 5 in the intervention and control tolas at baseline, 9 and 18 months. The intervention group will get immediate Rojiroti microfinance and the delayed group will wait 18 months. The weight for height Z score (WHZ) is the likely future primary outcome. However, we will collect data for other nutritional indices. We will use the measured effect size and summary statistics to calculate the sample size and power of a definitive trial. We will evaluate other outcomes, such as: <5 mortality, immunisation and indebtedness. We will collect preliminary qualitative data to investigate the mechanism of any effect.

We will enroll 60 tolas in 2 phases. Phase 1 (20 tolas) has begun, funded by the DfID GPAF. Consent and baseline measurements have been completed. Tolas are grouped in pairs of similar size and are >15km apart (to avoid "viral" spread of SHGs). Consent is requested at SHG level and the discussion is video recorded. Randomisation occurs after consent. Nutrition is assessed in all under fives in the tola, whether or not their mothers are in a SHG. The full feasibility and pilot study will take 2 years. We will then apply for funding for a definitive trial.

Planned Impact

Who will benefit from this research?
A. The clinical trials community
B. Women living in extreme poverty and their families
C. Users of the raw data: Bihar State Government; Epidemiological Researchers; Non Governmental Organisations working to alleviate poverty and malnutrition in the region
D. Rojiroti UK and the Centre for Promoting Sustainable Livelihood (CPSL)
E. Our group of collaborators. The MRC and partners who may fund future rounds of the Joint Global Health Trials scheme.

How will they benefit?
A. As described under "Academic Beneficiaries", the clinical trials community have already benefitted from the novel approach to consent, described in our published protocol (Trials 2014; 15(1): 298). It is challenging to obtain valid consent from women living in extreme poverty, many of whom will be illiterate. We hope that this approach will be useful to field investigators, evaluating complex interventions in poor communities.
B. We believe the model we have proposed emphasises partnership with trial participants. Our pilot data from 550 women in 20 tolas show that 36% of women reported forced asset sales in the previous 18 months and just 2% are allowed to travel outside of the tola without their husband's permission. Observational data show that participation in Rojiroti microfinance means women are less likely to be forced to sell assets and a greater proportion are able to travel without their husband's permission. So, irrespective of the outcome for child nutrition, participation in Rojiroti, through the proposed study, will result in female empowerment and in the reduction of poverty.
C. There are no current data on nutritional indices such as weight for height Z score (WHZ), stratified by age - for children in Bihar. We will collect these data and make the raw dataset available through the Dryad web repository. http://datadryad.org We have previously done this in other research published by our group (BMJ 2012; 344: d7373).
D. Both the nutritional and qualitative data will be used by Rojiroti UK and the (CPSL) to understand better the communities where Rojiroti microfinance is offered.
E. These data will allow us to design a future definitive trial which will have a robust sample size and adequate statistical power. The MRC and partners will benefit from a future high quality, well designed, grant application to the Joint Global Health Trials scheme or its successor. The definitive trial will be generalisable to similar populations in the region. Rojiroti microfinance is already operating at scale. Currently there are over 50,000 Rojiroti members (almost all women) in 4,100 self help groups in Northern India. If effective in improving child nutrition, the approach can be scaled up further to reach beneficiaries in poor communities throughout the region.

Publications

10 25 50
 
Description Women's empowerment and child health: exploring the impact of Rojiroti Microfinance in poor communities in Bihar, Northern India.
Amount £41,235 (GBP)
Funding ID MC_PC_MR/R024596/1 
Organisation Arts & Humanities Research Council (AHRC) 
Sector Public
Country United Kingdom
Start 04/2018 
End 09/2019
 
Description April 2017. Presentation at Annual Royal College of Paediatrics & Child Health Conference - plenary session 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The results of the cluster randomised trial of Rojiroti microfinance. We showed a significant difference in favour of the intervention for the primary outcome - weight for height Z score (WHZ) and the prevalence of wasting. After 18 months of microfinance, WHZ was significantly better in the intervention group (-1.02) vs. control (-1.37, p <0.001) and significantly fewer children were wasted in the intervention group (122, 18.1%) vs. control (200, 28.5%, p<0.001).
Year(s) Of Engagement Activity 2017
URL http://www.rcpch.ac.uk/annual-conference/rcpch-conference-2017
 
Description Dec 2016. Visit to project team in State of Bihar by co-applicant Dr Shalini Ojha 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Meeting with the NGO team delivering the intervention and the Clinical Academic Team evaluating the outcome (child nutrition).
Year(s) Of Engagement Activity 2016
 
Description Full protocol paper published in "Trials". 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact The full trial protocol has been published in "Trials" - an open access journal.
Year(s) Of Engagement Activity 2015
URL http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-15-298
 
Description March 2019. Networking Event & Workshop Exploring Link between Female Empowerment and Child Health at the A.N. Sinha Institute of Social Studies, Patna 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact We have been awarded £25,000 of Global Challenges Research Fund money to hold an "in country" workshop to discuss research priorities in evaluating and implementing the Rojiroti microfinance programme. This will be held on 18 March 2019.
Year(s) Of Engagement Activity 2019
URL http://ansiss.res.in
 
Description May 2018. Dissemination Workshop: "Women's Empowerment and Child Health: Exploring the Impact of Rojiroti Microfinance in Poor Communities in Bihar"- An Indo-UK collaboration 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact A daylong dissemination workshop on 'Women's Empowerment and Child Health: Exploring the Impact of Rojiroti Microfinance in Poor Communities in Bihar- an Indo-UK collaboration' was organized on 22nd May, 2018 at A N Sinha Institute of Social Studies, Patna. This workshop was organized by AN Sinha Institute of Social Studies, Patna and the Centre for Promoting Sustainable Livelihood, Patna in collaboration with Rojiroti Microfinance, UK and University of Nottingham, UK. The central objective of this workshop was to disseminate the findings of the project study titled 'A cluster randomised trial of the effects of the Rojiroti microfinance programme on nutrition in children under five, amongst the very poor in India'.

The speakers of this dissemination workshop were Prof. Alan Smyth, Professor of Child Health, University of Nottingham and Principle Investigator of the above project study, who presented the results and findings of the study along with Dr. Shalini Ojha. Prof DM Diwakar, former Director and presently Head of the Economics Division, ANSISS chaired the workshop and also tired to outline the collaboration between University of Nottingham and AN Sinha Institute of Social Studies. Other speakers were Dr. Gil Yaron, Director, GY Associates, UK, Dr. Shalini Ojha, Clinical Associate Prof. of Neonatology, Univ. of Nottingham, UK, Dr. Ranjeet Sinha, PMCH and OSD, Department of Health, Govt. of Bihar and Mr. Sunil Choudhary, Director, CPSL, Patna. Closing remarks and Vote of Thanks were presented by Dr. Rajeev Kamal Kumar, Asst. Prof. AN Sinha Institute of Social Studies, Patna.

In addition to the above, a separate session was devoted entirely to 'experience sharing' by the CPSL field workers and Rojiroti Self-Help Group members. The entire workshop was informative and interactive in nature and the participants benefitted thoroughly from the day long dissemination workshop.
Year(s) Of Engagement Activity 2018
URL http://ansiss.res.in
 
Description Nov 2013. Visit to study site by Prof Alan Smyth (University of Nottingham) & Dr Gil Yaron (Rojiroti UK) 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Study participants or study members
Results and Impact Prof Smyth & Dr Gil Yaron met with the NGO team delivering the intervention and the Clinical Academic Team evaluating the outcome (child nutrition).
Year(s) Of Engagement Activity 2013
 
Description Protocol summary on Clinicaltrials.gov 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Other audiences
Results and Impact The study protocol was made publicly available before the trial commenced on Clinicaltrials.gov
Year(s) Of Engagement Activity 2015
URL https://clinicaltrials.gov/ct2/show/record/NCT01845545?term=microfinance&rank=3
 
Description ROJIROTI EVALUATION ASSESSING CHILDREN'S HEALTH 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The REACH "ROJIROTI EVALUATION ASSESSING CHILDREN'S HEALTH" website summarises our project rationale protocol in language which is accessible both to professionals and the lay public. The website is in both English and Hindi.

The protocol has also been summarised in the following publication: Ojha S, Szatkowski L, Sinha R, et al. 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. Trials 2014; 15(1): 298.
Year(s) Of Engagement Activity 2015,2016
URL http://www.nottingham.ac.uk/reach/index.aspx