Economic evaluation of participatory women's groups scaled up by the public health system to improve birth outcomes in Jharkhand, eastern India.

An estimated 2.4 million newborn infants died in 2020, 80% of them in sub-Saharan Africa and South Asia. To achieve the Sustainable Development Target for neonatal mortality reduction, countries with high mortality need to implement evidence-based, cost-effective interventions at scale. Our study aimed to estimate the cost, cost-effectiveness, and benefit-cost ratio of a participatory women's groups intervention scaled up by the public health system in Jharkhand, eastern India. The intervention was evaluated through a pragmatic cluster non-randomised controlled trial in six districts. We estimated the cost of the intervention at scale from a provider perspective, with a 42-month time horizon for 20 districts. We estimated costs using a combination of top-down and bottom-up approaches. All costs were adjusted for inflation, discounted at 3% per year, and converted to 2020 International Dollars (INT$). Incremental cost-effectiveness ratios (ICERs) were estimated using extrapolated effect sizes for the impact of the intervention in 20 districts, in terms of cost per neonatal deaths averted and cost per life year saved. We assessed the impact of uncertainty on results through one-way and probabilistic sensitivity analyses. We also estimated benefit-cost ratio using a benefit transfer approach. Total intervention costs for 20 districts were INT$ 15,017,396. The intervention covered an estimated 1.6 million livebirths across 20 districts, translating to INT$ 9.4 per livebirth covered. ICERs were estimated at INT$ 1,272 per neonatal death averted or INT$ 41 per life year saved. Net benefit estimates ranged from INT$ 1,046 million to INT$ 3,254 million, and benefit-cost ratios from 71 to 218. Our study suggests that participatory women's groups scaled up by the Indian public health system were highly cost-effective in improving neonatal survival and had a very favourable return on investment. The intervention can be scaled up in similar settings within India and other countries.

Effects of community youth teams facilitating participatory adolescent groups, youth leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health among adolescent girls in rural eastern India (JIAH trial): A cluster-randomised controlled trial.

Objectives: To evaluate whether and how community youth teams facilitating participatory adolescent groups, youth leadership and livelihood promotion improved school attendance, dietary diversity, and mental health among adolescent girls in rural India. Design: A parallel group, two-arm, superiority, cluster-randomised controlled trial with an embedded process evaluation. Setting intervention and participants: 38 clusters (19 intervention, 19 control) in West Singhbhum district in Jharkhand, India. The intervention included participatory adolescent groups and youth leadership for boys and girls aged 10-19 (intervention clusters only), and family-based livelihood promotion (intervention and control clusters) between June 2017 and March 2020. We surveyed 3324 adolescent girls aged 10-19 in 38 clusters at baseline, and 1478 in 29 clusters at endline. Four intervention and five control clusters were lost to follow up when the trial was suspended due to the COVID-19 pandemic. Adolescent boys were included in the process evaluation only. Primary and secondary outcome measures: Primary: school attendance, dietary diversity, and mental health; 12 secondary outcomes related to education, empowerment, experiences of violence, and sexual and reproductive health. Results: In intervention vs control clusters, mean dietary diversity score was 4·0 (SD 1·5) vs 3·6 (SD 1·2) (adjDiff 0·34; 95%CI -0·23, 0·93, p = 0·242); mean Brief Problem Monitor-Youth (mental health) score was 12·5 (SD 6·0) vs 11·9 (SD 5·9) (adjDiff 0·02, 95%CI -0·06, 0·13, p = 0·610); and school enrolment rates were 70% vs 63% (adjOR 1·39, 95%CI 0·89, 2·16, p = 0·142). Uptake of school-based entitlements was higher in intervention clusters (adjOR 2·01; 95%CI 1·11, 3·64, p = 0·020). Qualitative data showed that the community youth team had helped adolescents and their parents navigate school bureaucracy, facilitated re-enrolments, and supported access to entitlements. Overall intervention delivery was feasible, but positive impacts were likely undermined by household poverty. Conclusions: Participatory adolescent groups, leadership training and livelihood promotion delivered by a community youth team did not improve adolescent girls' mental health, dietary diversity, or school attendance in rural India, but may have increased uptake of education-related entitlements. Trial registration: ISRCTN17206016.

Socioeconomic inequalities in stillbirth and neonatal mortality rates: evidence on Particularly Vulnerable Tribal Groups in eastern India.

BACKGROUND: Tribal peoples are among the most marginalised groups worldwide. Evidence on birth outcomes in these groups is scant. We describe inequalities in Stillbirth Rate (SBR), Neonatal Mortality Rate (NMR), and uptake of maternal and newborn health services between tribal and less disadvantaged groups in eastern India, and examine the contribution of poverty and education to these inequalities. METHODS: We used data from a demographic surveillance system covering a 1 million population in Jharkhand State (March 2017 - August 2019) to describe SBR, NMR, and service uptake. We used logistic regression analysis combined with Stata's adjrr-command to estimate absolute and relative inequalities by caste/tribe (comparing Particularly Vulnerable Tribal Groups (PVTG) and other Scheduled Tribes (ST) with the less marginalised Other Backward Class (OBC)/none, using the Indian government classification), and by maternal education and household wealth. RESULTS: PVTGs had a higher NMR (59/1000) than OBC/none (31/1000) (rate ratio (RR): 1.92, 95%CI: 1.55-2.38). This was partly explained by wealth and education, but inequalities remained large after adjustment (adjusted RR: 1.59, 95%CI: 1.28-1.98). NMR was also higher among other STs (44/1000), but disparities were smaller (RR: 1.47, 95%CI: 1.23-1.75). There was a systematic gradient in NMR by maternal education and household wealth. SBRs were only higher in poorer groups (RRpoorest vs. least poor:1.56, 95%CI: 1.14-2.13). Uptake of facility-based services was low among PVTGs (e.g. institutional birth: 25% vs. 69% in OBC/none) and among poorer and less educated women. However, 65% of PVTG women with an institutional birth used a maternity vehicle vs. 34% among OBC/none. Visits from frontline workers (Accredited Social Health Activists [ASHAs]) were similar across groups, and ASHA accompaniment of institutional births was similar across caste/tribe groups, and higher among poorer and less educated women. Attendance in participatory women's groups was similar across caste/tribe groups, and somewhat higher among richer and better educated women. CONCLUSIONS: PVTGs are highly disadvantaged in terms of birth outcomes. Targeted interventions that reduce geographical barriers to facility-based care and address root causes of high poverty and low education in PVTGs are a priority. For population-level impact, they are to be combined with broader policies to reduce socio-economic mortality inequalities. Community-based interventions reach disadvantaged groups and have potential to reduce the mortality gap.

Skin preparation for prevention of surgical site infection after obstetrics and gynecological abdominal surgery: A quality improvement project.

BACKGROUND: One of the most common causes of postoperative morbidity is postoperative surgical site infection (SSI). Healthcare-associated infection is a subject of great concern in healthcare services. The goal of the present study is to estimate the relative effectiveness of skin preparation solution chlorhexidine scrub followed by povidone-iodine painting in the prevention of SSIs after caesarean delivery and abdominal gynecological surgery. MATERIAL AND METHODS: This is a 1-year randomized prospective research done at a tertiary care institution in western Rajasthan. Women who underwent caesarean and gynecological operations were randomly assigned to one of two groups. Enrolled patients were randomly assigned to have the surgical site painted with 10% povidone-iodine or a chlorhexidine-alcohol preparatory scrub followed by povidone-iodine paint. According to the Centres for Disease Control and Prevention criteria, the outcomes were any SSI occurring within a week or during the 30-day follow-up period following the operation, including any superficial or deep SSI. RESULTS: A total of 251 patients were randomly assigned to two groups. Group A (povidone-iodine paint) received 121 patients, whereas Group B (chlorhexidine scrub + povidone-iodine paint) received 129 cases. The overall SSI rate in the present study was 8.76%. The SSI rate was lower in Group B (chlorhexidine scrub + povidone-iodine paint) as compared to Group A (povidone-iodine paint only) (5.4% vs. 12.4%; p = 0.04). CONCLUSION: This study highlighted that chlorhexidine-alcohol scrubbing followed by povidone-iodine painting provides superior skin antisepsis in comparison to povidone-iodine painting alone.

Effectiveness of participatory women's groups scaled up by the public health system to improve birth outcomes in Jharkhand, eastern India: a pragmatic cluster non-randomised controlled trial.

INTRODUCTION: The WHO recommends community mobilisation with women's groups practising participatory learning and action (PLA) to improve neonatal survival in high-mortality settings. This intervention has not been evaluated at scale with government frontline workers. METHODS: We did a pragmatic cluster non-randomised controlled trial of women's groups practising PLA scaled up by government front-line workers in Jharkhand, eastern India. Groups prioritised maternal and newborn health problems, identified strategies to address them, implemented the strategies and evaluated progress. Intervention coverage and quality were tracked state-wide. Births and deaths to women of reproductive age were monitored in six of Jharkhand's 24 districts: three purposively allocated to an early intervention start (2017) and three to a delayed start (2019). We monitored vital events prospectively in 100 purposively selected units of 10 000 population each, during baseline (1 March 2017-31 August 2017) and evaluation periods (1 September 2017-31 August 2019). The primary outcome was neonatal mortality. RESULTS: We identified 51 949 deliveries and conducted interviews for 48 589 (93.5%). At baseline, neonatal mortality rates (NMR) were 36.9 per 1000 livebirths in the early arm and 39.2 in the delayed arm. Over 24 months of intervention, the NMR was 29.1 in the early arm and 39.2 in the delayed arm, corresponding to a 24% reduction in neonatal mortality (adjusted OR (AOR) 0.76, 95% CI 0.59 to 0.98), including 26% among the most deprived (AOR 0.74, 95% CI 0.57 to 0.95). Twenty of Jharkhand's 24 districts achieved adequate meeting coverage and quality. In these 20 districts, the intervention saved an estimated 11 803 newborn lives (min: 1026-max: 20 527) over 42 months, and cost 41 international dollars per life year saved. CONCLUSION: Participatory women's groups scaled up by the Indian public health system reduced neonatal mortality equitably in a largely rural state and were highly cost-effective, warranting scale-up in other high-mortality rural settings. TRIAL REGISTRATION: ISRCTN99422435.

Community mobilisation to prevent violence against women and girls in eastern India through participatory learning and action with women's groups facilitated by accredited social health activists: a before-and-after pilot study.

BACKGROUND: Almost one in three married Indian women have ever experienced physical, sexual, or emotional violence from husbands in their lifetime. We aimed to investigate the preliminary effects of community mobilisation through participatory learning and action groups facilitated by Accredited Social Health Activists (ASHAs), coupled with access to counselling, to prevent violence against women and girls in Jharkhand, eastern India. METHODS: We piloted a cycle of 16 participatory learning and action meetings with women's groups facilitated by ASHAs in rural Jharkhand. Participants identified common forms of violence against women and girls, prioritised the ones they wanted to address, developed locally feasible strategies to address them, implemented the strategies, and evaluated the process. We also trained two counsellors and two ASHA supervisors to support survivors, and gave ASHAs information about legal, health, and police services. We did a before-and-after pilot study involving baseline and endline surveys with group members to estimate preliminary effects of these activities on the acceptability of violence, prevalence of past year emotional and physical violence, and help-seeking. RESULTS: ASHAs successfully conducted monthly participatory learning and action meetings with 39 women's groups in 22 villages of West Singhbhum district, Jharkhand, between June 2016 and September 2017. We interviewed 59% (679/1149) of women registered with groups at baseline, and 63% (861/1371) at endline. More women reported that violence was unacceptable in all seven scenarios presented to them at endline compared to baseline (adjusted Odds Ratio [aOR]: 1.87, 95%: 1.39-2.52). Fewer women reported experiencing emotional violence from their husbands in the last 12 months (aOR: 0.55, 95% CI: 0.43-0.71), and more sought help if it occurred (aOR: 2.19, 95% CI: 1.51-3.17). In addition, fewer women reported experiencing emotional or physical violence from family members other than their husbands in the last 12 months (aOR: 0.41, 95% CI: 0.32-0.53, and aOR: 0.36, 95% CI: 0.26-0.50, respectively). CONCLUSION: Combining participatory learning and action meetings facilitated by ASHAs with access to counselling was an acceptable strategy to address violence against women and girls in rural communities of Jharkhand. The approach warrants further implementation and evaluation as part of a comprehensive response to violence.

Community youth teams facilitating participatory adolescent groups, youth leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health among adolescent girls in rural eastern India: protocol for a cluster-randomised controlled trial.

BACKGROUND: Improving the health and development of adolescents aged 10-19 years is a global health priority. One in five adolescents globally live in India. The Rashtriya Kishor Swasthya Karyakram (RKSK), India's national adolescent health strategy, recommends supporting community-based peer educators to conduct group meetings with boys and girls. Groups aim to give adolescents a space to discuss the social and health issues affecting them and build their capacity to become active community members and leaders. There have been no evaluations of the community component of RKSK to date. In this protocol, we describe the evaluation of the Jharkhand Initiative for Adolescent Health (JIAH), a community intervention aligned with RKSK and designed to improve school attendance, dietary diversity and mental health among adolescent girls aged 10-19 years in rural Jharkhand, eastern India. METHODS: The JIAH intervention is delivered by a community youth team consisting of yuva saathis (friends of youth), youth leadership facilitators and livelihood promoters. Teams conduct (a) peer-led Participatory Learning and Action meetings with girls and boys, mobilising adolescents, parents, health workers, teachers and the wider community to make changes for adolescent health and development; (b) group-based youth leadership activities to build adolescents' confidence and resilience; and (c) livelihood promotion with adolescents and their families to provide training and practical skills. We are evaluating the JIAH intervention through a parallel-group, two-arm, superiority, cluster-randomised controlled trial. The unit of randomisation is a geographic cluster of ~1000 people. A total of 38 clusters covering an estimated population of 40,676 have been randomised to control or intervention arms. Nineteen intervention clusters have adolescent groups, youth leadership activities and livelihood promotion. Nineteen control clusters receive livelihood promotion only. Study participants are adolescent girls aged 10-19 years, married or unmarried, in or out of school, living in the study area. Intervention activities are open to all adolescent boys and girls, regardless of their participation in surveys. We will collect data through baseline and endline surveys. Primary trial outcomes are school attendance, dietary diversity and internalising and externalising mental health problems. Secondary outcomes include access to school-related entitlements, emotional or physical violence, self-efficacy and resilience. TRIAL REGISTRATION: ISRCTN17206016. Registered on 27 June 2018.

Mortality and recovery following moderate and severe acute malnutrition in children aged 6-18 months in rural Jharkhand and Odisha, eastern India: A cohort study.

BACKGROUND: Recent data suggest that case fatality from severe acute malnutrition (SAM) in India may be lower than the 10%-20% estimated by the World Health Organization (WHO). A contemporary quantification of mortality and recovery from acute malnutrition in Indian community settings is essential to inform policy regarding the benefits of scaling up prevention and treatment programmes. METHODS AND FINDINGS: We conducted a cohort study using data collected during a recently completed cluster-randomised controlled trial in 120 geographical clusters with a total population of 121,531 in rural Jharkhand and Odisha, eastern India. Children born between October 1, 2013, and February 10, 2015, and alive at 6 months of age were followed up at 9, 12, and 18 months. We measured the children's anthropometry and asked caregivers whether children had been referred to services for malnutrition in the past 3 months. We determined the incidence and prevalence of moderate acute malnutrition (MAM) and SAM, as well as mortality and recovery at each follow-up. We then used Cox-proportional models to estimate mortality hazard ratios (HRs) for MAM and SAM. In total, 2,869 children were eligible for follow-up at 6 months of age. We knew the vital status of 93% of children (2,669/2,869) at 18 months. There were 2,704 children-years of follow-up time. The incidence of MAM by weight-for-length z score (WLZ) and/or mid-upper arm circumference (MUAC) was 406 (1,098/2,704) per 1,000 children-years. The incidence of SAM by WLZ, MUAC, or oedema was 190 (513/2,704) per 1,000 children-years. There were 36 deaths: 12 among children with MAM and six among children with SAM. Case fatality rates were 1.1% (12/1,098) for MAM and 1.2% (6/513) for SAM. In total, 99% of all children with SAM at 6 months of age (227/230) were alive 3 months later, 40% (92/230) were still SAM, and 18% (41/230) had recovered (WLZ ≥ -2 standard deviation [SD]; MUAC ≥ 12.5; no oedema). The adjusted HRs using all anthropometric indicators were 1.43 (95% CI 0.53-3.87, p = 0.480) for MAM and 2.56 (95% CI 0.99-6.70, p = 0.052) for SAM. Both WLZ < -3 and MUAC ≥ 11.5 and < 12.5 were associated with increased mortality risk (HR: 3.33, 95% CI 1.23-8.99, p = 0.018 and HR: 3.87, 95% CI 1.63-9.18, p = 0.002, respectively). A key limitation of our analysis was missing WLZ or MUAC data at all time points for 2.5% of children, including for two of the 36 children who died. CONCLUSIONS: In rural eastern India, the incidence of acute malnutrition among children older than 6 months was high, but case fatality following SAM was 1.2%, much lower than the 10%-20% estimated by WHO. Case fatality rates below 6% have now been recorded in three other Indian studies. Community treatment using ready-to-use therapeutic food may not avert a substantial number of SAM-related deaths in children aged over 6 months, as mortality in this group is lower than expected. Our findings strengthen the case for prioritising prevention through known health, nutrition, and multisectoral interventions in the first 1,000 days of life, while ensuring access to treatment when prevention fails.

Effects of participatory learning and action with women's groups, counselling through home visits and crèches on undernutrition among children under three years in eastern India: a quasi-experimental study.

BACKGROUND: India faces a high burden of child undernutrition. We evaluated the effects of two community strategies to reduce undernutrition among children under 3 years in rural Jharkhand and Odisha, eastern India: (1) monthly Participatory Learning and Action (PLA) meetings with women's groups followed by home visits; (2) crèches for children aged 6 months to 3 years combined with monthly PLA meetings and home visits. METHODS: We tested these strategies in a non-randomised, controlled study with baseline and endline cross-sectional surveys. We purposively selected five blocks of Jharkhand and Odisha, and divided each block into three areas. Area 1 served as control. In Area 2, trained local female workers facilitated PLA meetings and offered counselling to mothers of children under three at home. In Area 3, workers facilitated PLA meetings, did home visits, and crèches with food and growth monitoring were opened for children aged 6 months to 3 years. We did a census across all study areas and randomly sampled 4668 children under three and their mothers for interview and anthropometry at baseline and endline. The evaluation's primary outcome was wasting among children under three in areas 2 and 3 compared with area 1, adjusted for baseline differences between areas. Other outcomes included underweight, stunting, preventive and care-seeking practices for children. RESULTS: We interviewed 83% (3868/4668) of mothers of children under three sampled at baseline, and 76% (3563/4668) at endline. In area 2 (PLA and home visits), wasting among children under three was reduced by 34% (adjusted Odds Ratio [aOR]: 0.66, 95%: 0.51-0.88) and underweight by 25% (aOR: 0.75, 95% CI: 0.59-0.95), with no change in stunting (aOR: 1.23, 95% CI: 0.96-1.57). In area 3, (PLA, home visits, crèches), wasting was reduced by 27% (aOR: 0.73, 95% CI: 0.55-0.97), underweight by 40% (aOR: 0.60, 95% CI: 0.47-0.75), and stunting by 27% (aOR: 0.73, 95% CI: 0.57-0.93). CONCLUSIONS: Crèches, PLA meetings and home visits reduced undernutrition among children under three in rural eastern India. These interventions could be scaled up through government plans to strengthen home visits and community mobilisation with Accredited Social Health Activists, and through efforts to promote crèches. TRIAL REGISTRATION: The evaluation was registered retrospectively with Current Controlled Trials as ISCRTN89911047 on 30/01/2019.

Adolescent girls' health, nutrition and wellbeing in rural eastern India: a descriptive, cross-sectional community-based study.

BACKGROUND: India is home to 243 million adolescents. Two million (9%) of them belong to Scheduled Tribes living in underserved, rural areas. Few studies have examined the health of tribal adolescents. We conducted a cross-sectional survey to assess the health, nutrition and wellbeing of adolescent girls in rural Jharkhand, eastern India, a state where 26% of the population is from Scheduled Tribes. We aimed to identify priorities for community interventions to serve adolescents and their families. METHODS: Between June 2016 and January 2017, interviewers visited all households in 50 purposively sampled villages of West Singhbhum district, Jharkhand. They aimed to interview all girls aged 10-19. Interviewers conducted face-to-face interviews with girls to administer a survey about physical and mental health, disability, nutrition, sexual and reproductive health, gender norms, decision-making, education and violence. Interviewers also measured girls' height, weight, and Mid-Upper Arm Circumference. RESULTS: Interviewers collected data from 3324 (82%) of an estimated 4068 girls residing in the study area. Their mean age was 14.3 (SD 2.9). 82% were from Scheduled Tribes. 89% of younger girls aged 10-14 and 46% of older girls aged 15-19 were in school or college. Girls dropped out of school because they were required for household work (37%) or work on the family farm or business (22%). Over a third reported symptoms of anaemia in the past month, but less than a fifth had a blood test. The prevalence of thinness (<-2SD median BMI for age and sex) was 14% for younger girls and 6% for older girls. 45% of girls were stunted (<-2SD median height for age and sex). 40% reported emotional violence in the past year, 14% physical violence, and 0.7% sexual violence. 12% had problems associated with depression or anxiety. 30% aged 15-19 had heard of contraception. Among married girls and their husbands, only 10% had ever used methods to prevent or delay pregnancy. CONCLUSIONS: Our study identified several priorities to improve adolescent girls' health, nutrition and wellbeing in largely tribal areas of Jharkhand: reducing violence, early marriage and undernutrition, as well as improving mental health, knowledge about contraception and school retention.

Effect of participatory women's groups and counselling through home visits on children's linear growth in rural eastern India (CARING trial): a cluster-randomised controlled trial.

BACKGROUND: Around 30% of the world's stunted children live in India. The Government of India has proposed a new cadre of community-based workers to improve nutrition in 200 districts. We aimed to find out the effect of such a worker carrying out home visits and participatory group meetings on children's linear growth. METHODS: We did a cluster-randomised controlled trial in two adjoining districts of Jharkhand and Odisha, India. 120 clusters (around 1000 people each) were randomly allocated to intervention or control using a lottery. Randomisation took place in July, 2013, and was stratified by district and number of hamlets per cluster (0, 1-2, or ≥3), resulting in six strata. In each intervention cluster, a worker carried out one home visit in the third trimester of pregnancy, monthly visits to children younger than 2 years to support feeding, hygiene, care, and stimulation, as well as monthly women's group meetings to promote individual and community action for nutrition. Participants were pregnant women identified and recruited in the study clusters and their children. We excluded stillbirths and neonatal deaths, infants whose mothers died, those with congenital abnormalities, multiple births, and mother and infant pairs who migrated out of the study area permanently during the trial period. Data collectors visited each woman in pregnancy, within 72 h of her baby's birth, and at 3, 6, 9, 12, and 18 months after birth. The primary outcome was children's length-for-age Z score at 18 months of age. Analyses were by intention to treat. Due to the nature of the intervention, participants and the intervention team were not masked to allocation. Data collectors and the data manager were masked to allocation. The trial is registered as ISCRTN (51505201) and with the Clinical Trials Registry of India (number 2014/06/004664). RESULTS: Between Oct 1, 2013, and Dec 31, 2015, we recruited 5781 pregnant women. 3001 infants were born to pregnant women recruited between Oct 1, 2013, and Feb 10, 2015, and were therefore eligible for follow-up (1460 assigned to intervention; 1541 assigned to control). Three groups of children could not be included in the final analysis: 147 migrated out of the study area (67 in intervention clusters; 80 in control clusters), 77 died after the neonatal period and before 18 months (31 in intervention clusters; 46 in control clusters), and seven had implausible length-for-age Z scores (<-5 SD; one in intervention cluster; six in control clusters). We measured 1253 (92%) of 1362 eligible children at 18 months in intervention clusters, and 1308 (92%) of 1415 eligible children in control clusters. Mean length-for-age Z score at 18 months was -2·31 (SD 1·12) in intervention clusters and -2·40 (SD 1·10) in control clusters (adjusted difference 0·107, 95% CI -0·011 to 0·226, p=0·08). The intervention did not significantly affect exclusive breastfeeding, timely introduction of complementary foods, morbidity, appropriate home care or care-seeking during childhood illnesses. In intervention clusters, more pregnant women and children attained minimum dietary diversity (adjusted odds ratio [aOR] for women 1·39, 95% CI 1·03-1·90; for children 1·47, 1·07-2·02), more mothers washed their hands before feeding children (5·23, 2·61-10·5), fewer children were underweight at 18 months (0·81, 0·66-0·99), and fewer infants died (0·63, 0·39-1·00). INTERPRETATION: Introduction of a new worker in areas with a high burden of undernutrition in rural eastern India did not significantly increase children's length. However, certain secondary outcomes such as self-reported dietary diversity and handwashing, as well as infant survival were improved. The interventions tested in this trial can be further optimised for use at scale, but substantial improvements in growth will require investment in nutrition-sensitive interventions, including clean water, sanitation, family planning, girls' education, and social safety nets. FUNDING: UK Medical Research Council, Wellcome Trust, UK Department for International Development (DFID).

Participatory women's groups and counselling through home visits to improve child growth in rural eastern India: protocol for a cluster randomised controlled trial.

BACKGROUND: Child stunting (low height-for-age) is a marker of chronic undernutrition and predicts children's subsequent physical and cognitive development. Around one third of the world's stunted children live in India. Our study aims to assess the impact, cost-effectiveness, and scalability of a community intervention with a government-proposed community-based worker to improve growth in children under two in rural India. METHODS: The study is a cluster randomised controlled trial in two rural districts of Jharkhand and Odisha (eastern India). The intervention tested involves a community-based worker carrying out two activities: (a) one home visit to all pregnant women in the third trimester, followed by subsequent monthly home visits to all infants aged 0-24 months to support appropriate feeding, infection control, and care-giving; (b) a monthly women's group meeting using participatory learning and action to catalyse individual and community action for maternal and child health and nutrition. Both intervention and control clusters also receive an intervention to strengthen Village Health Sanitation and Nutrition Committees. The unit of randomisation is a purposively selected cluster of approximately 1000 population. A total of 120 geographical clusters covering an estimated population of 121,531 were randomised to two trial arms: 60 clusters in the intervention arm receive home visits, group meetings, and support to Village Health Sanitation and Nutrition Committees; 60 clusters in the control arm receive support to Committees only. The study participants are pregnant women identified in the third trimester of pregnancy and their children (n = 2520). Mothers and their children are followed up at seven time points: during pregnancy, within 72 hours of delivery, and at 3, 6, 9, 12 and 18 months after birth. The trial's primary outcome is children's mean length-for-age Z scores at 18 months. Secondary outcomes include wasting and underweight at all time points, birth weight, growth velocity, feeding, infection control, and care-giving practices. Additional qualitative and quantitative data are collected for process and economic evaluations. DISCUSSION: This trial will contribute to evidence on effective strategies to improve children's growth in India. TRIAL REGISTRATION: ISRCTN register 51505201 ; Clinical Trials Registry of India number 2014/06/004664.