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Confidential: for Review Only Rojiroti Microfinance & Child Nutrition: a Cluster Randomised Trial Archives of Disease in Childhood Confidential: For Review Only Rojiroti microfinance & child nutrition: a cluster randomised trial Journal: Archives of Disease in Childhood Manuscript ID archdischild-2018-316471.R5 Article Type: Original article Edition: not in use Date Submitted by the n/a Author: Complete List of Authors: Ojha, Shalini; University of Nottingham, Academic Child Health Szatkowski, Lisa; University of Nottingham, Sinha, Ranjeet; Patna Medical College, Community Medicine Yaron, Gil; GY Associates Ltd and Trustee, Rojiroti UK Fogarty, Andrew; University of Nottingham, Epidemiology Allen, Stephen; The Liverpool School of Tropical Medicine, Child Health Choudhary, Sunil; Centre for Promoting Sustainable Livelihood (CPSL) Smyth, Alan; Nottingham Unversity, Child Health Microfinance, Low & Middle Income Countries, Wasting, Child growth, Keywords: Weight for height z score https://mc.manuscriptcentral.com/adc Page 1 of 39 Archives of Disease in Childhood 1 2 Rojiroti microfinance and child nutrition: a cluster randomised trial. 3 4 5 Authors: Shalini Ojha, Lisa Szatkowski, Ranjeet Sinha, Gil Yaron, Andrew Fogarty, 6 7 Stephen Allen, Sunil Choudhary, and Alan R Smyth 8 9 10 11 Trial registration. ClinicalTrials.gov NCT01845545 https://www.clinicaltrials.gov 12 Confidential: For Review Only 13 14 Shalini Ojha PhD 15 16 Clinical Associate Professor and Honorary Consultant in Neonatology, Division of Medical 17 18 19 Sciences and Graduate Entry Medicine, University of Nottingham, DE22 3DT, UK. 20 21 [email protected] 22 23 Lisa Szatkowski PhD 24 25 26 Associate Professor in Medical Statistics, Division of Epidemiology and Public Health, 27 28 University of Nottingham, NG5 1PB, UK. 29 30 [email protected] 31 32 Ranjeet Sinha MD PSM 33 34 35 Associate Professor in Community Medicine, Patna Medical College, Patna, Bihar, India. 36 37 [email protected] 38 39 Gil Yaron PhD 40 41 42 Director, GY Associates Ltd and Trustee, Rojiroti UK, 32 Amenbury Lane, Harpenden, AL5 43 44 2DF, UK 45 46 [email protected] 47 48 49 Andrew Fogarty DM 50 51 Clinical Associate Professor and Reader in Clinical Epidemiology, Clinical Sciences 52 53 Building, Nottingham City Hospital Campus, Nottingham, NG5 1PB, UK. 54 55 [email protected] 56 57 58 59 60 https://mc.manuscriptcentral.com/adc Archives of Disease in Childhood Page 2 of 39 1 Stephen Allen MD 2 3 Professor of Paediatrics, Department of Clinical Sciences, Liverpool School of Tropical 4 5 Medicine, Liverpool, L3 5QA 6 7 8 [email protected] 9 10 Sunil Choudhary BSc 11 12 CPSL, HouseConfidential: No-22, R.L. Enclave, Duplex For Colony, Review Near At Sonali Only Auto, Bye Pass Road, 13 14 15 Vishnupuri, Anishabad, Patna-800002, Bihar, India. 16 17 [email protected] 18 19 Alan R Smyth MD 20 21 22 Professor of Child Health, Division of Child Health, Obstetrics and Gynaecology, University 23 24 of Nottingham, NG7 2UH, UK. 25 26 [email protected] 27 28 29 30 31 32 33 Corresponding Author: Professor Alan R Smyth 34 35 36 Word count: Abstract = 270; Main text = 3070. 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/adc Page 3 of 39 Archives of Disease in Childhood 1 ABSTRACT 2 3 4 Objective 5 6 7 To determine whether Rojiroti microfinance, for poor Indian women, improves child 8 9 nutrition. 10 11 12 Design Confidential: For Review Only 13 14 15 Cluster randomised trial. 16 17 18 Setting 19 20 21 Tolas (village communities) in Bihar State. 22 23 24 Participants 25 26 27 Women and children under 5 years. 28 29 30 Interventions 31 32 33 In Rojiroti, women form self-help groups and save their money to provide loans to group 34 35 members. After 6 months, they receive larger external loans. Tolas were randomised to 36 37 receive Rojiroti immediately or after 18 months. 38 39 40 Outcome measures 41 42 43 The primary analysis compared the mean weight for height Z score (WHZ) of all children 44 45 46 under 5 years in the intervention vs. control tolas, who attended for weight and height 47 48 measurement 18 months after randomisation. Secondary outcomes were weight for age Z 49 50 score (WAZ), height for age Z score (HAZ), mid-upper arm circumference (MUAC), 51 52 53 wasting, underweight, and stunting. 54 55 56 Results 57 58 We randomised 28 tolas to each arm and collected data from 2469 children (1560 59 60 mothers) at baseline and 2064 children (1326 mothers) at follow-up. WHZ was calculated for 1718 children at baseline and 1377 at follow up. At 18 months, mean WHZ was https://mc.manuscriptcentral.com/adc Archives of Disease in Childhood Page 4 of 39 1 significantly higher for intervention (-1·02) vs. controls (-1·37; regression coefficient 2 3 adjusted for clustering β=0·38, 95% CI 0·16-0·61, p=0·001). WHZ in controls deteriorated 4 5 from baseline whilst the intervention arm showed little change. Significantly fewer children 6 7 8 were wasted in the intervention group (122, 18%) vs. control (200, 29%; odds ratio=0·46, 9 10 95% CI 0·28-0·74, p=0·002). Mean WAZ was better in the intervention group 11 12 Confidential: For Review Only 13 (-2·13 vs. -2·37; β=0·27, 95% CI 0·11-0·43, p=0·001) as was MUAC (13·6cm vs. 13·4cm; 14 15 β=0·22, 95% CI 0·03-0·40, p=0·02). 16 17 Conclusion 18 19 20 In marginalised communities in rural India, child nutrition was better in those who received 21 22 Rojiroti microfinance, compared to controls. 23 24 25 Trial registration. ClinicalTrials.gov NCT01845545 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/adc Page 5 of 39 Archives of Disease in Childhood 1 INTRODUCTION 2 3 4 Globally, 50 million children under five years suffer from acute malnutrition or wasting 5 6 (weight for height Z score of below -2).1 These children are at least three times more likely 7 8 2 1 9 to die than their better-nourished peers. Two thirds live in Asia. Ending all forms of child 10 11 malnutrition by 2030 is a Sustainable Development Goal.3 In spite of programmes to 12 Confidential: For Review Only 13 address malnutrition in almost all low and middle income countries (LMICs), acute 14 15 4 16 malnutrition remains highly prevalent. 17 18 19 Child health follows a social gradient where wealthier means healthier.5 Recent economic 20 21 growth in India has not led to a reduction in childhood undernutrition.6 Bihar (population 22 23 24 116 million) is one of the poorest and most deprived states in India (population 1.3 billion). 25 26 Nearly 90% of the population is rural and has poor access to health-care and education. 27 28 Of the 100 districts in India with the highest prevalence of malnutrition, 23 are in Bihar.7 29 30 Rojiroti (“daily bread”) microfinance has been operating in Bihar since 2001.8 Participants 31 32 33 are women and 62% are from scheduled castes (disadvantaged groups, recognised in the 34 35 Indian Constitution).8 It is delivered by the non-governmental organisation (NGO) the 36 37 Centre for Promoting Sustainable Livelihood (CPSL). Women form self-help groups 38 39 40 (SHGs) and contribute their own savings to a fund, from which they can request small 41 42 loans. Later, women may become eligible for larger loans funded by CPSL (see panel).9 43 44 45 Our hypothesis was that Rojiroti microfinance would improve nutrition amongst children 46 47 48 under five years. We tested this through a cluster randomised trial, based in rural tolas 49 50 (village neighbourhoods of around 500 people of similar socio-economic status and caste). 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/adc Archives of Disease in Childhood Page 6 of 39 1 METHODS 2 3 4 Study design 5 6 7 We conducted a matched pair, cluster randomised controlled trial (RCT) with a 1:1 8 9 9 10 allocation ratio. The protocol has been published and the trial is registered 11 12 (ClinicalTrials.gov,Confidential: NCT01845545). Ethics For approval Review was granted byOnly the University of 13 14 Nottingham’s Medical School Research Ethics Committee (J18102012) and by the Patna 15 16 17 Medical College Ethics Committee (15 August 2013). Approval was obtained from the 18 19 Department of Health, Government of Bihar, India (SHSB/NRC/2008/01/Part III/2615). Our 20 21 findings are reported in line with the CONSORT extension for cluster randomised trials.10 22 23 24 25 Participants were village women, mostly from scheduled castes in four administrative 26 27 blocks in Patna District (Dulhin Bazar, Naubatpur, Masaurhi, and Bikram; figure 1) were 28 29 chosen because of proximity to the teams from CPSL and Patna Medical College. We 30 31 approached the next 60 tolas, due to be offered Rojiroti (on the basis of need). SHG 32 33 34 membership was open to any woman in the tola. All children in the tola were invited for 35 36 weighing and measuring, irrespective of whether their mother was an SHG member. There 37 38 were no exclusion criteria. 39 40 41 42 Consent and Randomisation 43 11 44 We followed the CONSORT guidelines on consent for cluster randomised trials.
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