SummaryBackgroundAround 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.MethodsWe 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).ResultsBetween 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...

Big Lottery Fund (UK).

BackgroundProvision of essential newborn care (ENC) can save many newborn lives in poor resource settings but coverage is far from universal and varies by country and place of delivery. Understanding gaps in current coverage and where coverage is good, in different contexts and places of delivery, could make a valuable contribution to the future design of interventions to reduce neonatal mortality. We sought to describe the coverage of essential newborn care practices for births in institutions, at home with a skilled birth attendant, and at home without a skilled birth attendant (SBA) in rural areas of Bangladesh, Nepal, and India.MethodsWe used data from the control arms of four cluster randomised controlled trials in Bangladesh, Eastern India and from Makwanpur and Dhanusha districts in Nepal, covering periods from 2001 to 2011. We used these data to identify essential newborn care practices as defined by the World Health Organization. Each birth was allocated to one of three delivery types: home birth without an SBA, home birth with an SBA, or institutional delivery. For each study, we calculated the observed proportion of births that received each care practice by delivery type with 95% confidence intervals, adjusted for clustering and, where appropriate, stratification.ResultsAfter exclusions, we analysed data for 8939 births from Eastern India, 27 553 births from Bangladesh, 6765 births from Makwanpur and 15 344 births from Dhanusha. Across all study areas, coverage of essential newborn care practices was highest in institutional deliveries, and lowest in home non-SBA deliveries. However, institutional deliveries did not provide universal coverage of the recommended practices, with relatively low coverage (20%-70%) across all study areas for immediate breastfeeding and thermal care. Institutions in Bangladesh had the highest coverage for almost all care practices except thermal care. Across all areas, fewer than 20% of home non-SBA deliveries used a clean delivery kit, the use of plastic gloves was very low and coverage of recommended thermal care was relatively poor. There were large differences between study areas in handwashing, immediate breastfeeding and delayed bathing.ConclusionsThere remains substantial scope for health facilities to improve thermal care for the newborn and to encourage immediate and exclusive breastfeeding. For unattended home deliveries, increased handwashing, use of clean delivery kits and basic thermal care offer great scope for improvement.

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BackgroundChild 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.MethodsThe 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.DiscussionThis trial will contribute to evidence on effective strategies to improve children's growth in India.Trial registrationISRCTN register 51505201; Clinical Trials Registry of India number 2014/06/004664.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-015-1655-z) contains supplementary material, which is available to authorized users.