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
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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
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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
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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
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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
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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. Only 45 46 46% of women in rural Bihar are literate12 and so trial information was conveyed verbally 47 48 (in Hindi). A CPSL volunteer explained that: 49 50 51 52 The trial involved random allocation to immediate or delayed Rojiroti. 53 54 In the delayed (control) group, participants could not implement Rojiroti for 18 55 56 months. 57 58 59 Tolas declining the trial, could access Rojiroti through the normal procedure. 60 In control tolas, women could join non-Rojiroti SHGs.
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1 Women indicated if they agreed or declined to participate by show of hands. The 2 3 discussion and vote were video recorded. Written informed consent was obtained from 4 5 one literate representative of the women. Consent for the child to participate was 6 7 8 confirmed verbally when the children were weighed and measured. 9 10 11 12 Panel. TheConfidential: principles of Rojiroti microfinance. For Review Only 13 14 15 Women are asked to form self-help groups (SHGs). 16 17 They contribute small amounts of money to a communal fund 18 19 (approximately Rs2·5, or 4 U.S. cents, per member per week). 20 21 22 Women are expected to attend at least 4 SHG meetings (held weekly), 23 24 before their savings entitle them to a loan. 25 26 These loans are initially small (Rs50) and come from the SHG fund. 27 28 29 After 6 months, women in the SHG are entitled to receive larger, external 30 31 loans from CPSL of between Rs500 ($7) and Rs3,000 ($44), provided 32 33 SHG credit is good. 34 35 36 There are no restrictions on the use of loans. 37 38 39 40 Following consent, tolas of similar size were paired by researchers in Patna and given a 41 42 43 tola ID by the research team in Nottingham. Tolas in each pair were randomly assigned to 44 45 receive Rojiroti immediately (Intervention) or after the final 18 month measurements 46 47 (Control) by the blinded researchers in Nottingham, using a computer-generated random 48 49 50 number table. Intervention tolas were at least 15 km from any control tola to minimise “viral 51 52 spread” of the intervention. CPSL then implemented Rojiroti in the intervention tolas, 53 54 starting with establishing self-help groups. Data-analysts, but not field-workers, were 55 56 blinded to allocation. The tola was the unit of randomisation and the child the unit of 57 58 59 analysis. 60
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1 Procedures 2 3 4 Phase one (feasibility) recruitment took place Aug-Sept 2013 (20 tolas). Once feasibility 5 6 was established the pilot stage commenced, with phase two recruitment (30 tolas Feb-Mar 7 8 9 2014). Recruitment stopped during the monsoon and phase three recruitment (6 tolas) 10 11 was in Sept 2014. At baseline, we collected data about each tola and demographic data 12 Confidential: For Review Only 13 for each mother and child. The age, sex, weight, length/height, and mid-upper arm 14 15 16 circumference (MUAC) were recorded for all children under five years of age (and over 6 17 18 months for MUAC).9 We used the following equipment for the age groups listed. 19 20 21 Length: (<2 years) Seca 210 Measuring Mat. Standing height: (≥2 years) Seca 22 23 24 213 Portable Stadiometer (both Seca, Birmingham, UK). 25 26 Weight: (<6 months) Docbel Baby Scales (Popular, Docbel Industries, New Delhi, 27 28 India); (6 months - 2 years) hanging scales (Venus CHS, Ace, Rajasthan, India); 29 30 31 (≥2 years) Libra Fitness Standing Scale (Edryl, Goa, India). 32 33 MUAC: (>6 months) MUAC tapes (UNICEF Supply Division). 34 35 36 Equipment was calibrated, using standard measures, at the beginning of each visit. After 37 38 39 setting the scales to zero, each child was weighed and measured three times and the 40 41 middle value used.13 Children were weighed and measured by CPSL workers, who were 42 43 trained by staff from Patna Medical College, prior to the baseline and 18 month visits. 44 45 Rojiroti then began in the tolas randomised to the intervention. CPSL staff met with women 46 47 48 regularly to record how loans were used. 49 50 51 At 18 months, all children under five, present in the tola, were invited for weighing and 52 53 measurement. Mothers and children who were also present at the baseline survey were 54 55 56 identified by unique ID codes. Children aged 5.0 to 6½ years, who took part in initial data 57 58 collection, were included to enable a longitudinal analysis of their growth. CPSL staff 59 60 conducted one visit to each tola (to weigh and measure the children) at baseline and
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1 follow up. Data were recorded on paper forms, entered electronically in Patna and 2 3 transferred to Nottingham for analysis. In Nottingham a random 10% of the electronic data 4 5 were checked against the paper records. Errors were found in <1% of those checked. 6 7 8 9 Statistical analysis 10 11 12 Data were Confidential:checked for spurious age, height, For and Review weight entries using Only the Emergency 13 14 Nutrition Assessment (ENA) Tool and implausible data excluded.14 Analysis was 15 16 17 performed using Stata 14 (StataCorp, College Station, TX). 18 19 20 Outcome measures: In our feasibility phase, the primary outcome was mortality and this 21 22 was registered in clinicaltrials.gov (NCT01845545) in April 2013. The feasibility phase 23 24 25 began in August 2013 but it proved impossible to collect reliable data on mortality. The 26 27 primary outcome was therefore changed to mean weight for height Z score (WHZ). This is 28 29 recorded in our published protocol9 in July 2014 and subsequently amended on 30 31 clinicaltrials.gov. Data collection was completed in March 2016. 32 33 34 35 36 We assessed the following primary and secondary outcomes at 18 months. 37 38 Primary outcome: mean weight for height Z score (WHZ). 39 40 41 Secondary outcomes: 42 43 • Mean weight for age Z score (WAZ) and height for age Z score (HAZ). 44 45 46 • Prevalence of moderate to severe: wasting (WHZ below -2SD); undernutrition (WAZ 47 48 below -2SD); stunting (HAZ below -2SD). 49 50 51 • Mean MUAC 52 53 • Prevalence of: moderate acute malnutrition (MUAC 12·5 to 11·5cm); severe 54 55 56 malnutrition (MUAC <11·5cm) 57 58 59 WHZ, HAZ, and WAZ were calculated from the 2006 World Health Organisation growth 60 standards,15 using the ‘zscore06’ function in Stata. We calculated WAZ and HAZ (using
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1 WHO AnthroPlus software) for children aged 5 to 6½ years at follow up and for whom we 2 3 had baseline data, to enable the longitudinal analysis described below. We did not 4 5 calculate WHZ for this age group because there are no reference values. 6 7 8 9 Sample size calculation: We used data from the feasibility phase on WHZ and the 10 11 number of children per tola to determine the sample size and the number of tolas needed.9 12 Confidential: For Review Only 13 Previous work has suggested that, where programmes achieve an improvement in Z score 14 15 16 of 0·1 to 0·5, this has a meaningful effect on the prevalence of malnutrition in young 17 18 children.16 There were on average 40 children under five in each of the first 20 tolas and 19 20 the mean baseline WHZ score was -0·96 (SD 1·04). Baseline intracluster correlation 21 22 23 coefficient was 0·082. We used the Stata function “clustersampsi” which implements the 24 25 sample size calculation procedures detailed by Hayes and Bennett.17 We calculated that, 26 27 recruiting 60 tolas and allowing for 10% attrition, gave 80% power (alpha 0·05) to detect a 28 29 difference in mean WHZ score of 0·26 standard deviations between groups. We therefore 30 31 32 decided to continue the trial, with the aim of recruiting 60 tolas, as there would be sufficient 33 34 statistical power to detect a meaningful difference (if present) in the primary outcome. 35 36 37 In cross-sectional analyses mean (SD) WHZ, HAZ, WAZ, MUAC, and the prevalence of 38 39 40 binary outcomes, were calculated at 18 months. Linear or logistic regression models were 41 42 used to quantify the difference in outcomes between children in intervention and control 43 44 tolas at follow-up, using a multilevel model, with tola ID as a random effects variable, to 45 46 47 account for clustering by tola. These models were not adjusted for baseline nutritional 48 49 status, as many of the children were new to the tola at follow-up (babies born since 50 51 baseline assessment and families who have moved to the tola). An interaction term was 52 53 used to test whether the effect of the intervention varied between boys and girls. 54 55 56 57 58 We measured two potential harms of the programme in participating women at 18 months, 59 60 using the Chi squared test.
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1 Freedom to travel without the permission of a male relative – usually the husband 2 3 (travel might be restricted if Rojiroti participation causes domestic disputes). 4 5 6 Forced asset sales (which might arise if Rojiroti increased indebtedness). 7 8 9 10 We performed two post hoc analyses which were not specified in our protocol (results in 11 12 Confidential: For Review Only supplementary material). 13 14 15 1. A longitudinal analysis of participants who took part both at baseline and follow-up. 16 17 This used a repeated measures generalised linear mixed model18 and adjusted for 18 19 potentially confounding variables (shown in Supplementary Figure 1A) as measured at 20 21 22 baseline. 23 24 2. Whether the effects of the intervention varied according to mothers’ SHG membership. 25 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
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1 RESULTS 2 3 4 Between August 2013 and September 2014, 60 tolas were approached, 56 consented and 5 6 28 were randomised to each arm (figure 2). All 56 tolas provided data for the primary 7 8 9 analysis. The final 18 month follow-up visit was in March 2016. Baseline characteristics of 10 11 the tolas are in table 1. Baseline data were collected from 2469 children (1560 mothers) in 12 Confidential: For Review Only 13 56 tolas (table 1). Baseline, demographic and nutritional data for the children in the 14 15 16 intervention and control arms are shown in table 1. There was no difference between arms 17 18 in WHZ at baseline (calculated in 1718 of 2469 children), although more children were 19 20 wasted in the intervention arm (20%) vs. controls (15%). Conversely, in the control group, 21 22 23 HAZ was worse (-2.14 vs. -2.00) and more children had MUAC <12.5cm (16% vs. 13%). 24 25 26 Cross-sectional analysis of effect of Rojiroti on undernutrition 27 28 29 At 18 months, data were collected from 2064 children under five (1326 mothers) – see 30 31 figure 2. We excluded 687 children from the analysis of WHZ because their data were 32 33 34 either missing or flagged as spurious by the ENA tool; 1377 children were included 35 36 (anthropometric data shown in table 2). 37 38 39 The primary outcome (mean WHZ in children under five) at 18 months, was significantly 40 41 42 higher in the intervention than control tolas (-1·02 vs. -1.37, regression coefficient, 43 44 adjusted for clustering β=0·38, 95% CI 0·16 to 0·61, p=0·001). The WHZ in the control 45 46 arm deteriorated, compared to baseline, whilst the intervention arm showed little change. 47 48 49 The following secondary outcomes were also significantly better in the intervention tolas 50 51 compared to controls: mean WAZ (-2·13 vs. -2·37), MUAC (13·6cm vs. 13·4cm), wasting 52 53 prevalence (18% vs. 29%), underweight prevalence (53% vs. 63%), and prevalence of 54 55 MUAC <12.5cm (13% vs. 18%) (table 2). There was no evidence for effect modification by 56 57 58 child sex (all p-values from interaction terms >0·05, results not shown). 59 60
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1 To look at the effects of Rojiroti on the same children measured at baseline and at 18 2 3 months, we performed a subgroup analysis (supplementary table 1 and supplementary 4 5 figure 1). Of the 2469 children and 1560 mothers who were included at baseline, 1457 6 7 8 (59%) children and 894 (57%) mothers were included in this analysis at follow-up. There 9 10 was a significant difference in the trajectories of change in favour of the intervention group 11 12 for the outcomesConfidential: of WHZ (p=0·006) and For WAZ (p<0·001) Review in this analysis. Only When we 13 14 15 compared the adjusted difference in intervention vs. control at follow-up for WHZ, HAZ, 16 17 WAZ and MUAC in the longitudinal subgroup (supplementary table 1) we found that only 18 19 the difference in WAZ was statistically significant 0.28 (95% CI 0.16 to 0.39, p<0·001). 20 21 22 Nutritional outcomes were similar in children in intervention tolas whether or not their 23 24 mothers were members of a Rojiroti SHG. There were no differences with non-Rojiroti 25 26 SHG membership (supplementary table 2). 27 28 29 Outcomes for women 30 31 32 33 At 18 months, 33 (5%) women in the intervention group and 31 (5%) in the control group 34 35 were free to travel without the permission of a male relative (p=0.5). Forced asset sales 36 37 during the study period were similar in the two groups: intervention 16 women (2%) vs. 38 39 40 control 15 (2%) (p=0·8). There were 1134 loans and the total borrowed was Rs2,499,532 41 42 ($36,858). The mean loan value was Rs2,204 ($32). Figure 3 shows the percentage of 43 44 loans (A) and the amount borrowed (B) for each category of use. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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1 2 DISCUSSION 3 4 5 Our cluster randomised trial showed better child nutrition in tolas which received Rojiroti 6 7 8 microfinance. There was a difference of 0·35 in mean WHZ and only 18% of children in the 9 10 intervention group were wasted vs. 29% of controls. There was no effect on HAZ which 11 12 measures chronicConfidential: undernutrition and can affectFor future Review cognitive development. Only19 We believe this 13 14 15 may be related to our short follow up period of 18 months. However, a recent trial has shown an 16 17 improvement in HAZ over a shorter period than our study (6 and 12 months) with a cash 18 19 transfer intervention.20 20 21 22 23 24 A recent, systematic review of the health impacts of group-based microfinance programmes 25 26 found no randomised trial, with child health outcomes.21 There has been little rigorous, 27 28 evaluation of the impact of microfinance.22,23 Our study is the first randomised controlled trial to 29 30 24 31 evaluate the effects of microfinance on child nutrition. The only previous randomised study did 32 33 not consider child health outcomes. Of the non-randomised studies, with child health outcomes, 34 35 some have suggested a benefit,25-27 whilst others have shown either no benefit28 or worse 36 37 29 38 nutrition in the children of microfinance participants. 39 40 41 In our cross-sectional and longitudinal analyses, nutritional indices did not improve in the 42 43 intervention group but worsened in controls, suggesting that Rojiroti prevented deterioration in 44 45 nutritional status. For phase one and three tolas, the 18 month follow-up occurred just before 46 47 30 48 the Rabi harvest (wheat and lentils, March-April). For phase two tolas, the final visit was two 49 50 months before the Kharif harvest (rice and lentils, November-December).30 The scarcity of 51 52 staple foods at follow-up may explain the deterioration in the control group. Similar seasonal 53 54 31 55 variations in children’s growth have been observed in rural Africa. Rojiroti microfinance may 56 57 confer resilience on the community during periods of shortage. 58 59 60
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1 2 This trial has limitations. The results may not be applicable outside Bihar. Our primary outcome 3 4 was mean WHZ in the intervention and control tolas at 18 months. This outcome has the 5 6 7 limitation that the same children we not measured at baseline and 18 months. Also, we do not 8 9 know what proportion of the children in each village attended for weighing and measuring. 10 11 However longitudinal data from the same children at baseline and follow up corroborate these 12 Confidential: For Review Only 13 14 findings for WHZ and WAZ (supplementary material). We included data from phase one 15 16 (feasibility) in our final analysis, as the power calculation, based on phase one data, indicated 17 18 this trial could reach a definitive conclusion. Data on length or height were missing in around 19 20 20% of children (mostly too young to stand). At baseline we excluded 751 of 2469 children, and 21 22 23 at 18 months 687 of 2064 children, from WHZ analysis because of spurious or missing data 24 25 (figure 2). In a future trial we will have increased quality assurance to reduce errors in 26 27 measurement and recording. Rather than applying a correction for multiple hypothesis testing, 28 29 30 we have presented full data, with 95% confidence intervals (CIs) and p-values, to allow the 31 32 reader to judge the weight of evidence. The nutritional benefit in children was seen whether or 33 34 not their mothers received the intervention. This may be attributable to a “trickle down” of wealth 35 36 37 in the community but might also be due to the higher degree of landownership, literacy and 38 39 schooling which occurred, by chance, in the women comprising the intervention group. 40 41 42 The defining characteristics of Rojiroti must be understood, if the approach is to be used 43 44 elsewhere (see panel). The small sums and time-consuming meetings mean that Rojiroti is 45 46 47 attractive only to the very poor. There are no restrictions on the use of loans and yet repayment 48 49 rates are around 99%.8 The price of defaulting on a loan is not loss of the borrower’s property 50 51 but loss of access to affordable credit. Rojiroti is therefore distinct from women’s groups linked 52 53 32 54 to cash transfer. 55 56 57 Women only agreed to participate because they knew that tolas allocated to control would 58 59 receive Rojiroti after 18 months. We do not know if benefits are seen beyond the 18 months. 60 We have shown the percentage of loans and amounts borrowed in each category (figure 3). By
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1 2 both criteria, the three most common uses are medical expenses, social and religious 3 4 obligations and working capital for agriculture. Future research should evaluate effects on 5 6 7 harms (such as domestic violence) and how access to credit for some mothers can benefit the 8 9 children in the whole community. Our theory of change diagram (supplementary figure 2) shows 10 11 how these factors may interact and postulates mechanisms for the Rojiroti effect. 12 Confidential: For Review Only 13 14 15 Women participants were very poor (10% land ownership) and there were very low levels of 16 17 decision making agency (only 5% could travel without permission). Less than 20% were literate 18 19 vs. 46% literacy among most rural women in Bihar.12 Children showed a higher prevalence of 20 21 wasting, stunting, underweight and moderate malnutrition than reported in the National Family 22 23 12 24 Health Survey 4. The Rojiroti approach is designed for very poor communities and may not 25 26 show the same benefits where poverty is less extreme. 27 28 29 Rojiroti has grown organically in Northern India over the last 15 years. There are now 30 31 8 32 approximately 31,000 members in 3,100 SHGs in Bihar. Scaling up the intervention can 33 34 happen with modest funding and could deliver better health for children. 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
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1 2 AUTHORS’ CONTRIBUTION 3 4 5 Study design SO, LS, AF, SA and ARS. Organisation and conduct RS, GY, SC. Analysis LS, 6 7 8 SO, AF, ARS. Manuscript written by SO and ARS and revised by all the authors. 9 10 11 ROLE OF THE FUNDING SOURCE 12 Confidential: For Review Only 13 14 This work was supported by the Medical Research Council; Wellcome Trust; the Department of 15 16 17 Health and Social Care; and Department for International Development (both UK Government) 18 19 as part of the joint global health trials scheme [grant number MR/M021904/1]. Funders had no 20 21 role in design and conduct of the study; collection, management, analysis, and interpretation of 22 23 the data; and preparation, review, or approval of the manuscript; and decision to submit the 24 25 26 manuscript for publication. The corresponding author had full access to all the data in the study 27 28 and takes responsibility for the integrity of the data and the accuracy of the data analysis. 29 30 31 CONFLICT OF INTEREST STATEMENT 32 33 34 35 GY is a Trustee of Rojiroti UK. SC is CEO of the Centre for Promoting Sustainable Livelihood. 36 37 The remaining authors have no conflicts of interest. 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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1 2 What is already known on this topic: 3 4 Microfinance programmes have been implemented widely in poor communities in low 5 6 7 and middle income countries (LMICs). 8 9 Some microfinance programmes have brought economic benefits to female participants. 10 11 Studies evaluating the impact of microfinance on child health and nutrition have not been 12 Confidential: For Review Only 13 14 rigorous and results have been conflicting. 15 16 17 18 What this study adds: 19 20 21 In a cluster randomised trial, we found that several indices of child nutrition were better, 22 23 at 18 months, in the groups randomised to Rojiroti microfinance. 24 25 Weight for height Z score (primary outcome) was significantly better in the intervention 26 27 28 group (-1·02) vs. controls (-1·37). 29 30 In poor and marginalised communities in Bihar, Rojiroti microfinance appears to prevent 31 32 a deterioration in nutritional indices, in children under five, at times of food insecurity. 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
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1 2 REFERENCES 3 4 5 6 7 1. Joint Child Malnutrition Estimates. Levels and trends in child malnutrition. New York, 8 9 10 Geneva, Washinghton DC: UNICEF, WHO, World Bank Group 2016. 11 12 http://www.who.int/nutgrowthdb/jme_brochure2016.pdf?ua=1Confidential: For Review Only (accessed Feb 2018) 13 14 15 2. Black RE, Allen LH, Bhutta ZA, et al. Maternal and child undernutrition: global and 16 17 18 regional exposures and health consequences. Lancet. 2008;371(9608):243-260. 19 20 21 3. Transforming our world: the 2030 Agenda for Sustainable Development. United Nations - 22 23 Sustainable Development knowledge platform. 24 25 26 https://sustainabledevelopment.un.org/index.html (accessed Feb 2018). 27 28 29 4. Essential Nutrition Actions: improving maternal, newborn, infant and young child health 30 31 and nutrition. Geneva: WHO; 2013. 32 33 http://apps.who.int/iris/bitstream/10665/84409/1/9789241505550_eng.pdf (accessed Feb 34 35 36 2018) 37 38 39 5. Commission on Social Determinants of Health Final Report. Geneva: World Health 40 41 Organization; 2006. 42 43 44 http://www.who.int/social_determinants/thecommission/finalreport/en/ (accessed Feb 45 46 2018) 47 48 49 6. Subramanyam MA, Kawachi I, Berkman LF, Subramanian SV. Is economic growth 50 51 52 associated with reduction in child undernutrition in India? PLoS medicine. 53 54 2011;8(3):e1000424. 55 56 57 58 59 60
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1 2 7. The HUNGaMA Fighting Hunger and Nutrition Survey Report. Hyderabad, India: Naandi 3 4 Foundation; 2011. http://www.naandi.org/wp-content/uploads/2013/12/HUNGaMA- 5 6 7 Survey-2011-The-Report.pdf (accessed Feb 2018) 8 9 10 8. Yaron G, Kelly B, Choudhary S, Kumar R, Best J, Gaunt J. Innovative microfinance for 11 12 the veryConfidential: poor: assessing the impact Forof the Rojiroti Review approach. Harpenden:Only Rojiroti UK; 13 14 15 2011. 16 17 http://www.rojiroti.org/downloads/Impact_study_RIU_P1064_Promoting_sustainable_livel 18 19 ihoods_28_May_2011.pdf (accessed Feb 2018) 20 21 22 9. Ojha S, Szatkowski L, Sinha R, et al. Feasibility and pilot study of the effects of 23 24 25 microfinance on mortality and nutrition in children under five amongst the very poor in 26 27 India: study protocol for a cluster randomized controlled trial. Trials. 2014;15(1):298. 28 29 30 10. Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension 31 32 33 to cluster randomised trials. BMJ. 2012;345:e5661. 34 35 36 11. Weijer C, Grimshaw JM, Eccles MP, et al. The Ottawa Statement on the Ethical Design 37 38 and Conduct of Cluster Randomized Trials. PLoS medicine. 2012;9(11):e1001346. 39 40 41 42 12. National Family Health Survey (NFHS-4), India 2015-16, Bihar. Mumbai: International 43 44 Institute for Population Sciences; 2016. http://rchiips.org/nfhs/factsheet_NFHS-4.shtml 45 46 (accessed Feb 2018) 47 48 49 13. Cole TJ, Cortina Borja M. Optimal treatment of replicate measurements in 50 51 52 anthropometric studies Annals of Human Biology. 2016;43(5):492. 53 54 55 14. Software for Emergency Nutrition Assessment. 2011; http://www.nutrisurvey.de/ena2011/ 56 57 accessed Feb 2018]. 58 59 60
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1 2 15. WHO child growth standards and the identification of severe acute malnutrition in infants 3 4 and children. A Joint Statement by the World Health Organization and the United Nations 5 6 7 Children’s Fund. Geneva: WHO; 2009. 8 9 http://www.who.int/nutrition/publications/severemalnutrition/9789241598163/en/ 10 11 (accessed Feb 2018) 12 Confidential: For Review Only 13 14 15 16. Caulfield LE, Huffman SL, Piwoz EG. Interventions to Improve Intake of Complementary 16 17 Foods by Infants 6 to 12 Months of Age in Developing Countries: Impact on Growth and 18 19 on the Prevalence of Malnutrition and Potential Contribution to Child Survival. Food Nutr 20 21 Bull. 1999;20(2):183-200. 22 23 24 25 17. Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J 26 27 Epidemiol. 1999;28(2):319-326. 28 29 30 18. Marquis GS, Colecraft EK, Sakyi-Dawson O, et al. An integrated microcredit, 31 32 33 entrepreneurial training, and nutrition education intervention is associated with better 34 35 growth among preschool-aged children in rural Ghana. J Nutr. 2015;145(2):335-343. 36 37 38 19. Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B. 39 40 41 Developmental potential in the first 5 years for children in developing countries. Lancet. 42 43 2007;369(9555):60-70. 44 45 46 20. Fenn B, Colbourn T, Dolan C, Pietzsch S, Sangrasi M, Shoham J. Impact evaluation of 47 48 different cash-based intervention modalities on child and maternal nutritional status in 49 50 51 Sindh Province, Pakistan, at 6 mo and at 1 y: A cluster randomised controlled trial. PLoS 52 53 medicine. 2017;14(5):e1002305. 54 55 56 21. Orton L, Pennington A, Nayak S, Sowden A, White M, Whitehead M. Group-based 57 58 59 microfinance for collective empowerment: a systematic review of health impacts. Bull 60 World Health Organ. 2016;94(9):694-704.
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1 2 22. van Rooyen C, Stewart R, de Wet T. The Impact of Microfinance in Sub-Saharan Africa: 3 4 A Systematic Review of the Evidence. World Dev. 2012;40(11):2249-2262. 5 6 7 8 23. Duvendack M, Palmer-Jones R, Copestake J, Hooper L, Loke Y, Rao N. What is the 9 10 evidence of the impact of microfinance on the well-being of poor people? London: EPPI- 11 12 Centre,Confidential: Social Science Research Unit, For Institute Review of Education, OnlyUniversity of London; 2011. 13 14 15 https://assets.publishing.service.gov.uk/media/57a08aeeed915d622c0009bb/Microfinanc 16 17 e2011Duvendackreport.pdf (accessed Feb 2018) 18 19 20 24. Banerjee A, Duflo E, Glennerster R, Kinnan C. The Miracle of Microfinance? Evidence 21 22 from a Randomized Evaluation. Am Econ J Appl Econ. 2015;7(1):22-53. 23 24 25 26 25. Khatun M, Stenlund H, Hornell A. BRAC initiative towards promoting gender and social 27 28 equity in health: a longitudinal study of child growth in Matlab, Bangladesh. Public Health 29 30 Nutr. 2004;7(8):1071-1079. 31 32 33 34 26. Jalal CS, Frongillo EA. Effect of poverty reduction program on nutritional status of the 35 36 extreme poor in Bangladesh. Food Nutr Bull. 2013;34(4):402-411. 37 38 39 27. MkNelly B, Dunford C. Impact of credit with education on mothers and their young 40 41 42 children’s nutrition. California: University of California, Davis; 1998 43 44 www.microfinancegateway.org/library/impact-credit-education-mothers-and-their-young- 45 46 childrens-nutrition-crecer-credit-education (accessed Feb 2018) 47 48 49 28. Moseson H, Hamad R, Fernald L. Microcredit participation and child health: results from 50 51 52 a cross-sectional study in Peru. J Epidemiol Community Health. 2014;68(12):1175-1181. 53 54 55 29. Doocy S, Teferra S, Norell D, Burnham G. Credit program outcomes: coping capacity 56 57 and nutritional status in the food insecure context of Ethiopia. Soc Sci Med. 58 59 60 2005;60(10):2371-2382.
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1 2 30. National Food Security Mission. Crop Calendar Bihar. Ministry of Agriculture & Farmers’ 3 4 Welfare Government of India. http://nfsm.gov.in/nfmis/RPT/CalenderReport.aspx 5 6 7 (accessed Feb 2018) 8 9 10 31. Nabwera HM, Fulford AJ, Moore SE, Prentice AM. Growth faltering in rural Gambian 11 12 childrenConfidential: after four decades of interventions: For Reviewa retrospective cohort Only study. Lancet Glob 13 14 15 Health. 2017;5(2):e208-e216. 16 17 18 32. Saville NM, Shrestha BP, Style S, et al. Impact on birth weight and child growth of 19 20 Participatory Learning and Action women’s groups with and without transfers of food or 21 22 cash during pregnancy: Findings of the low birth weight South Asia cluster-randomised 23 24 25 controlled trial (LBWSAT) in Nepal. PLOS ONE. 2018;13(5):e0194064. 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
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1 2 FIGURE LEGENDS 3 4 5 6 7 8 9 Figure 1. The State of Bihar, showing Patna District, with the participating administrative blocks 10 11 (“tehsils”) of Dulhin Bazar, Naubatpur, Masurhi, and Bikram 12 Confidential: For Review Only 13 14 15 16 17 18 Figure 2. CONSORT diagram for cluster randomised controlled trial of the Rojiroti microfinance 19 20 programme, showing the number of children contributing to the primary outcome (WHZ) at 18 21 22 months. 23 24 25 26 27 28 29 Figure 3. Use of loans by women in the intervention tolas, showing % of loans granted (A) and 30 31 total amount borrowed in each category (B). 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
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1 Participating tolas Intervention Control 2 p-value 3 (n = 28) (n = 28) 4 Connected to a paved road (n, %) 28 (100) 27 (96) 0.3 5 Distance from main road (km) (median, 1 (0·3 to 4) 0·9 (0·45 to 3·5) 0.8 6 interquartile range - IQR) 7 PDS* shop (n, %) 11 (39) 14 (50) 0.4 8 9 Government primary school (n, %) 28 (100) 27 (96) 0.3 10 Other school (n, %) 13 (46) 8 (29) 0.2 11 Primary health centre (n, %) 0 (0) 0 (0) - 12 Presence ofConfidential: an ASHA** worker (n, %) For26 (93) Review27 (96)Only 0.6 13 Presence of an ANM*** (n, %) 26 (93) 25 (89) 0.6 14 Presence of a water tap or pipeline (n, %) 0 (0) 0 (0) - 15 16 Presence of electricity supply (n, %) 28 (100) 28 (100) - 17 *PDS, public distribution system (a network of subsidised government stores) 18 **ASHA, Accredited Social Health Activists (local women, trained in health promotion) 19 ***ANM, Auxiliary Nurse Midwife (village level maternal & child health worker) 20 Participating women Intervention Control 21 p-value (n=756) (n=804) 22 23 Number of women per tola (median, IQR) 25·5 (17·5 to 38) 27 (18·5 to 36·5) 0.9 24 Age in years (mean, SD) 27·6 (5·5) 27·6 (5·3) 0.9 25 Family owns land (n, %) 100 (13) 64 (8) 0.001 26 Able to travel outside of tola without 61 (8) 27 (3) <0.001 27 permission from male relative (n, %) 28 Able to read and write (n, %) 158 (21) 132 (16) 0.05 29 Attended school (n, %) 145 (19) 103 (13) 0.001 30 Intervention Control 31 Participating children p-value 32 (n= 1175) (n=1294) 33 Median (IQR) no. children per tola 43 (27 to 57) 47 (28 to 59) 0.6 34 No. male, (%) 612 (52) 650 (50) 0.4 35 Mean (SD) age in months 30·9 (16·8) 31·2 (16·9) 0.6 36 Born at home (n, %) 356 (30) 359 (28) 0.2 37 Road to health† card (n, %) 1055 (90) 1166 (90) 0.8 38 †† 39 Immunised (n, %) 1125 (96) 1257 (97) 0.06 40 †Road to health card is a summary of health & growth of the child in the first five years of life. 41 ††Immunisation defined as maternal recall of any immunisation received by the child. 42 Baseline nutritional measures n n 43 Intervention Control p value‡‡ 44 of participating children Intervention‡ Control‡ 45 WHZ (mean, SD) -1·00 (1·16) 808 -0·94 (1·00) 910 0·3 46 HAZ (mean, SD) -2·00 (1·29) 808 -2·14 (1·33) 910 0·03 47 WAZ (mean, SD) -1·89 (1·10) 985 -1·96 (1·10) 1170 0·2 48 MUAC (mean, SD) 13·6 (1·14) 933 13·6 (1·25) 1080 0.5 49 Wasted (n, %) 159 (20) 808 138 (15) 910 0·01 50 Stunted (n, %) 399 (49) 808 489 (54) 910 0·07 51 Underweight (n, %) 436 (44) 985 548 (47) 1170 0·2 52 MUAC <12·5cm (n, %) 122 (13) 933 176 (16) 1080 0·04 53 MUAC <11·5cm (n, %) 24 (3) 933 44 (4) 1080 0·06 54 ‡The number of children contributing to each outcome measure is given in each row. 55 ‡‡p values from t-test for continuous outcomes and chi-squared for binary outcomes 56 57 Table 1. Baseline characteristics of participating tolas, women and children. Intervention = immediate 58 Rojiroti. Control = delayed Rojiroti. 59 60
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1 2 n for each n for each β/OR* (95% CI) for 3 Intervention outcome Control outcome intervention vs. control ICC p value 4 (Intervention ) (Control) at follow-up 5 6 WHZ (mean, SD) -1·02 (1·11) 674 -1·37 (1·10) 703 β = 0·38 (0·16 to 0·61) 0·108 0·001 7 8 HAZ (mean, SD) Confidential:-2·37 (1·29) 674 -2For·53 (1·25) Review703 β = 0·17 Only (-0·04 to 0·37) 0·053 0·1 9 10 WAZ (mean, SD) -2·13 (1·03) 842 -2·37 (1·05) 871 β = 0·27 (0·11 to 0·43) 0·051 0·001 11 MUAC (mean, SD) 811 828 β = 0·22 (0·03 to 0·40) 12 13·6 (1·10) 13·4 (1·12) 0·063 0·02 13 Wasted (n, %) 122 (18) 674 200 (29) 703 OR = 0·46 (0·28 to 0·74) 0·134 0·002 14 15 Stunted (n, %) 421 (63) 674 465 (66) 703 OR = 0·82 (0·60 to 1·12) 0·044 0·2 16 17 Underweight (n, %) 446 (53) 842 545 (63) 871 OR = 0·63 (0·47 to 0·84) 0·042 0·002 18 19 MUAC <12.5cm (n, %) 102 (13) 811 152 (18) 828 OR = 0·65 (0·41 to 1·05) 0·116 0·08 20 21 MUAC <11.5cm (n, %) 24 (3) 811 37 (5) 828 OR = 0·70 (0·36 to 1·33) 0·097 0·3 22 23 Supine length or standing height was measured in 81% of children at baseline and 79% at follow-up. 24 Weight was measured in 99% of children at baseline and 99% at follow-up. 25 In children aged 6-59 months, MUAC was measured in 99% of children at baseline and 99% at follow-up. 26 27 28 *β is the regression coefficient for continuous outcomes and OR is the odds ratio, both adjusted for clustering. ICC is the intracluster correlation 29 coefficient (proportion of the total variance of the outcome that can be explained by the variation between clusters). 30 31 32 Table 2. Cross-sectional analysis of the effects of the Rojiroti microfinance programme on nutritional status of children under five years of 33 age at 18 month follow-up. Not all outcome measures could be recorded for each child and so the number of children contributing to each 34 outcome is listed. Intervention = immediate Rojiroti. Control = delayed Rojiroti. 35 36 37 38 39 40 41 42 43 https://mc.manuscriptcentral.com/adc 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Page 27 of 39 Archives of Disease in Childhood
1 2 3 4 5 6 7 8 9 10 11 Confidential: For Review Only 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Figure 1. The State of Bihar, showing Patna District, with the participating administrative blocks (“tehsils”) of 32 Dulhin Bazar, Naubatpur, Masurhi, and Bikram 33 160x120mm (300 x 300 DPI) 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 Archives of Disease in Childhood Page 28 of 39
1 2 3 4 5 6 7 8 9 10 11 Confidential: For Review Only 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Figure 2. CONSORT diagram for cluster randomised controlled trial of the Rojiroti microfinance programme, 32 showing the number of children contributing to the primary outcome (WHZ) at 18 months. 33 160x120mm (300 x 300 DPI) 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 29 of 39 Archives of Disease in Childhood
1 2 3 4 5 6 7 8 9 10 11 Confidential: For Review Only 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Figure 3. Use of loans by women in the intervention tolas, showing % of loans granted (A) and total amount 32 borrowed in each category (B). 33 160x120mm (300 x 300 DPI) 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 Archives of Disease in Childhood Page 30 of 39
1 2 3 SUPPLEMENTARY STATISTICAL ANALYSIS 4 5 Rojiroti microfinance & child nutrition: a cluster randomised trial. 6 7 8 Authors: Shalini Ojha, Lisa Szatkowski, Ranjeet Sinha, Gil Yaron, Andrew Fogarty, 9 Stephen Allen, Sunil Choudhary, and Alan R Smyth 10 11 12 Confidential: For Review Only 13 14 15 16 17 18 19 20 21 22 23 24 25 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
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1 SUPPLEMENTARY METHODS 2 3 4 Growth trajectory over 18 months in children measured both at baseline and 18 5 6 7 months 8 9 In children with linked baseline and follow-up data we examined the trajectory of change in 10 11 z-scores and MUAC between baseline and follow-up. Children aged over three and a half 12 Confidential: For Review Only 13 years at baseline were over five years at 18 month follow up and, for these, we used WHO 14 15 16 AnthroPlus to calculate HAZ and WAZ.1 There are no WHZ standards for children aged 17 18 over five years and so analysis of this outcome includes only children who were under five 19 20 at follow-up. Any child where the outcome variable was recorded as having changed by >3 21 22 2 23 standard deviations was excluded from the analysis . We compared the trajectory of 24 25 change in z-scores and MUAC, between baseline and follow-up, using a repeated 26 27 measures, generalised linear mixed model. We examined the interaction between time 28 29 30 point and group allocation to assess whether the trajectory of change varied between 31 32 children in intervention and control tolas. In line with previous work,2 potential tola, mother 33 34 and child-level confounders were added to the models if at baseline they were univariably 35 36 associated with group allocation or the outcome (based on a value of p<0·25) or if they 37 38 39 were considered a priori to be important factors in child growth (e.g. maternal education). 40 41 The age and sex of the child and the number of children aged under five in the family were 42 43 included a priori in all models. The tola ID was included as a random effects variable. A 44 45 46 backward model fitting approach was used and variables kept in the model if p<0·1. The 47 48 confounders included in the model for each anthropometric measure are shown in 49 50 Supplementary Figure 1A. We have also calculated the adjusted difference in intervention 51 52 53 vs. control tolas (95% CI, p-value) in WHZ, WAZ, HAZ and MUAC. 54 55 56 57 58 59 60
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1 Effects of mothers’ SHG membership on nutritional outcomes in children under 5 2 3 years. 4 5 In order to examine whether any effects of the intervention varied according to mothers’ 6 7 8 SHG membership, linear and logistic regression analysis were repeated comparing all 9 10 children measured at baseline in intervention and control tolas using a four level exposure 11 12 variable: Confidential: For Review Only 13 14 15 control and mother not a member of an SHG (reference category) 16 17 control but mother a member of a non-Rojiroti SHG 18 19 mother in intervention tola and member of a Rojiroti SHG 20 21 22 mother in intervention tola but not a member of a Rojiroti SHG 23 24 25 26 27 28 29 SUPPLEMENTARY RESULTS 30 31 32 33 Growth trajectory over 18 months 34 35 36 Of those who were surveyed at baseline, 1457 (59%) children and 894 (57%) mothers also 37 38 participated in the follow-up and could be included in the longitudinal analysis. Of the 39 40 children who took part at baseline, 470 were aged over five years at follow up and were 41 42 43 only included in the in the analysis of growth trajectory. There was no significant difference 44 45 in follow-up rates between intervention and control tolas. 46 47 48 49 Supplementary Figure 1B shows the trajectory of change in z-scores and MUAC between 50 51 52 baseline and follow-up, for those children included at both time points, with the p-values 53 54 for the time*group interaction term. There was a significant difference in the trajectories of 55 56 change in the intervention and control groups for the outcomes of WHZ (p=0·006) and 57 58 59 WAZ (p<0·001); z scores worsened in all groups but more so in the control tolas. 60 However, there was no significant difference in the trajectories of change in HAZ and
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1 MUAC between intervention and control groups. The magnitude of change in the 2 3 anthropometric parameters among this subgroup of children was similar to that in the 4 5 cross-sectional analysis; however, due to the smaller sample size, the statistical power to 6 7 8 detect differences was reduced. 9 10 11 12 SupplementaryConfidential: Table 1 shows the results For for the Review subgroup of children Only who were present 13 14 15 for measurement both at baseline and follow-up. In Supplementary Table 1, we show 16 17 adjusted least square means with their standard errors for WHZ, HAZ, WAZ and MUAC in 18 19 intervention and control tolas at baseline and follow-up for children with linked data, 20 21 22 derived from a repeated measures generalised linear mixed model. The p-values for the 23 24 time*group interaction term suggest there was a difference between intervention and 25 26 control tolas in the pattern of change in WHZ (p=0·006) and WAZ (p<0·001) across the 18- 27 28 month study period. WHZ and WAZ worsened in both groups over time, but less so in 29 30 31 children in intervention tolas compared to children in control tolas. HAZ and MUAC both 32 33 improved over time but there were no differences between groups. 34 35 36 37 38 Supplementary table 1 also shows the adjusted difference in intervention vs. control at 39 40 baseline and follow-up for WHZ, HAZ, WAZ and MUAC. At follow up, in this analysis, only 41 42 the difference in WAZ was statistically significant (0.28, 95% CI 0.16 to 0.39, p<0·001). 43 44 45 46 47 Effects of mothers’ SHG membership 48 49 In the intervention group, 35% of women overall (median by tola 37%, interquartile range 50 51 8% - 59%) reported being members of a Rojiroti SHG. In control tolas, 29% of women 52 53 54 overall (median by tola 24%, interquartile range 0% - 54%) reported being a member of a 55 56 non-Rojiroti SHG. Comparisons of the mean z-scores and odds ratios for binary outcomes 57 58 at follow-up in children in intervention and control tolas according to maternal SHG 59 60 membership are given in Supplementary Table 2. The regression coefficients and odds
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1 ratios were similar in children in intervention tolas in both the children of women who were 2 3 members of a Rojiroti SHG and the children of women who were not members. There 4 5 were no significant differences between children of women in control tolas who were 6 7 8 members of a non-Rojiroti SHG and those who were not. 9 10 11 12 Confidential: For Review Only 13 14 15 16 17 18 19 20 21 22 23 24 25 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
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1 2 3 4 5 6 7 p-value for Adjusted difference in Intervention Control 8 time*group intervention vs. control group group 9 interaction (95% CI, p-value) 10 11 WHZ (n) (257) (291) 12 Confidential: For Review Only -0·90 ± 13 Baseline -1·01 ± 0·07 0·006 -0.11 (-0.29 to 0.07, p=0·2) 14 0·06 15 -1·39 ± 16 Follow-up -1·22 ± 0·07 0.16 (-0.02 to 0.34, p=0·08) 17 0·06 18 HAZ (n) (415) (520) 19 20 -2·17 ± Baseline -1·96 ± 0·06 0·09 0.20 (0.05 to 0.36, p=0·009) 21 0·05 22 -2·06 ± 23 Follow-up -1·95 ± 0.06 0.11 (-0.04 to 0.27, p=0·1) 24 0·05 25 26 WAZ (n) (530) (669) 27 -1·96 ± Baseline -1·90 ± 0·04 <0·001 0.06 (-0.05 to 0.18, p=0·3) 28 0·04 29 30 -2·32 ± Follow-up -2·04 ± 0·04 0.28 (0.16 to 0.39, p<0·001) 31 0·04 32 33 MUAC (n) (332) (379) 34 35 Baseline 13·2 ± 0·06 13·2 ± 0·06 0·2 0.01 (-0.15 to 0.17, p=0·9) 36 Follow-up 14·0 ± 0·06 13·9 ± 0·06 0.13 (-0.03 to 0.29, p=0·1) 37 38 39 40 Supplementary Table 1. Longitudinal analysis of the effects of the Rojiroti 41 42 microfinance programme on nutritional status of children in the subgroup who 43 44 45 were present both at baseline and follow-up. Adjusted least square mean ± 46 47 standard error for interaction term (group x time point) from repeated measures 48 49 generalised linear mixed model and adjusted difference in intervention vs. control 50 51 at baseline and follow-up are presented. 52 53 54 55 56 57 58 59 60
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p-value 1 2 Mean z-score (β, 95% CI for group vs. control) difference 3 between groups 4 Control Control Intervention Intervention 5 non-SHG SHG member non-SHG member SHG member 6 member 7 8 WHZ -1·35Confidential: (ref) -1·45 (-0·10, -0·31 to 0·11) For-1·02 (0·36, Review 0·11 to 0·61) -0·99 Only(0·32, 0·06 to 0·59) 0·01 9 HAZ -2·53 (ref) -2·55 (0·00, -0·23 to 0·24) -2·37 (0·15, -0·09 to 0·39) -2·35 (0·21, -0·05 to 0·47) 0·4 10 11 WAZ -2·35 (ref) -2·44 (-0·08, -0·26 to 0·09) -2·16 (0·22, 0·04 to 0·40) -2·05 (0·29, 0·09 to 0·49) 0·007 12 13 MUAC (cm) 13·4 (ref) 13·4 (-0·03, -0·22 to 0·16) 13·6 (0·15, -0·06 to 0·36) 13·7 (0·25, 0·02 to 0·47) 0·1 14 p-value 15 % (OR, 95% CI for group vs. control) difference 16 between groups 17 18 Wasted 26 (ref) 33·5 (1·42, 0·91 to 2·22) 17·2 (0·48, 0·28 to 0·84) 19·1 (0·60, 0·33 to 1·09) 0·007 19 Stunted 66 (ref) 68·0 (1·05, 0·71 to 1·57) 63·4 (0·89, 0·62 to 1·28) 60·3 (0·73, 0·49 to 1·09) 0·4 20 21 Underweight 63 (ref) 62·9 (1·02, 0·72 to 1·45) 55·8 (0·71, 0·51 to 0·99) 46·6 (0·52, 0·36 to 0·75) 0·003 22 MUAC 23 17 (ref) 19·2 (1·18, 0·74 to 1·87) 13·9 (0·77, 0·45 to 1·30) 10·2 (0·65, 0·35 to 1·20) 0·4 24 <12.5cm 25 MUAC 5 (ref) 3·4 (0·73, 0·31 to 1·74) 3·4 (0·78, 0·37 to 1·66) 2·2 (0·55, 0·20 to 1·51) 0.7 26 <11.5cm 27 28 CI, confidence interval; OR, odds ratio; ref. reference group; WHZ, weight for height z-score; HAZ, height for age z-score; WAZ, weight for age z- 29 30 score; MUAC, mid-upper arm circumference; wasted, WHZ <-2SD; stunted, HAZ<-2SD; underweight, WAZ<-2SD 31 32 33 34 Supplementary Table 2. Comparison of mean z-scores and odds ratios at follow-up in children in intervention vs. control tolas according to 35 36 mother’s self-help group membership. 37 38 39 40 41 42 43 https://mc.manuscriptcentral.com/adc 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Page 37 of 39 Archives of Disease in Childhood
1 2 3 4 5 6 REFERENCES 7 8 1. WHO AnthroPlus software. Growth reference 5-19 years. Geneva: WHO; 9 2009. http://www.who.int/growthref/tools/en/ (accessed Feb 2018) 10 11 12 2. MarquisConfidential: GS, Colecraft EK, Sakyi-Dawson For Review O, et al. An integrated Only microcredit, 13 entrepreneurial training, and nutrition education intervention is associated with 14 better growth among preschool-aged children in rural Ghana. J Nutr. 15 2015;145(2):335-343. 16 17 3. Yaron G, Gordon R, Best J, Choudhary S. Microfinance for the marginalized: 18 the impact of the Rojiroti approach in India. Enterprise Development and 19 20 Microfinance. 2018;29(1):80-93. 21 22 23 24 25 26 Supplementary Figure 1. 27 28 A. Confounders included in the model for each anthropometric measure 29 30 B. Trajectories of change in anthropometric measures between baseline and 31 32 33 follow-up in intervention and control tolas. Error bars represent 95% 34 35 confidence intervals. P values are for the time*group interaction term from a 36 37 repeated measures generalised linear mixed model. 38 39 40 41 42 Supplementary Figure 2. Theory of change diagram of how Rojiroti may improve 43 44 child nutrition. Intermediate & longer term outcomes are “assumptions” apart from 45 46 those shaded which have been demonstrated in our field study.3 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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1 2 3 4 5 6 7 8 9 10 11 Confidential: For Review Only 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Supplementary Figure 1. 32 A. Confounders included in the model for each anthropometric measure 33 B. Trajectories of change in anthropometric measures between baseline and follow-up in intervention and control tolas. Error bars represent 95% confidence intervals. P values are for the time*group interaction 34 term from a repeated measures generalised linear mixed model. 35 36 37 254x190mm (72 x 72 DPI) 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 39 of 39 Archives of Disease in Childhood
1 2 3 4 5 6 7 8 9 10 11 Confidential: For Review Only 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Supplementary Figure 2. Theory of change diagram of how Rojiroti may improve child nutrition. 32 Intermediate & longer term outcomes are “assumptions” apart from those shaded which have been 33 demonstrated in our field study.3 34 254x190mm (72 x 72 DPI) 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