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BackgroundFew large and rigorous evaluations of participatory interventions systematically describe their context and implementation, or attempt to explain the mechanisms behind their impact. This study reports process evaluation data from the Ekjut cluster-randomised controlled trial of a participatory learning and action cycle with women's groups to improve maternal and newborn health outcomes in Jharkhand and Orissa, eastern India (2005-2008). The study demonstrated a 45% reduction in neonatal mortality in the last two years of the intervention, largely driven by improvements in safe practices for home deliveries.MethodsA participatory learning and action cycle with 244 women's groups was implemented in 18 intervention clusters covering an estimated population of 114 141. We describe the context, content, and implementation of this intervention, identify potential mechanisms behind its impact, and report challenges experienced in the field. Methods included a review of intervention documents, qualitative structured discussions with group members and non-group members, meeting observations, as well as descriptive statistical analysis of data on meeting attendance, activities, and characteristics of group attendees.ResultsSix broad, interrelated factors influenced the intervention's impact: (1) acceptability; (2) a participatory approach to the development of knowledge, skills and 'critical consciousness'; (3) community involvement beyond the groups; (4) a focus on marginalized communities; (5) the active recruitment of newly pregnant women into groups; (6) high population coverage. We hypothesize that these factors were responsible for the increase in safe delivery and care practices that led to the reduction in neonatal mortality demonstrated in the Ekjut trial.ConclusionsParticipatory interventions with community groups can influence maternal and child health outcomes if key intervention characteristics are preserved and tailored to local contexts. Scaling-up such interventions requires (1) a detailed understanding of the way in which context affects the acceptability and delivery of the intervention; (2) planned but flexible replication of key content and implementation features; (3) strong support for participatory methods from implementing agencies.

Big Lottery Fund (UK).

BackgroundPublic health interventions are increasingly evaluated using cluster-randomised trials in which groups rather than individuals are allocated randomly to treatment and control arms. Outcomes for individuals within the same cluster are often more correlated than outcomes for individuals in different clusters. This needs to be taken into account in sample size estimations for planned trials, but most estimates of intracluster correlation for perinatal health outcomes come from hospital-based studies and may therefore not reflect outcomes in the community. In this study we report estimates for perinatal health outcomes from community-based trials to help researchers plan future evaluations.MethodsWe estimated the intracluster correlation and the coefficient of variation for a range of outcomes using data from five community-based cluster randomised controlled trials in three low-income countries: India, Bangladesh and Malawi. We also performed a simulation exercise to investigate the impact of cluster size and number of clusters on the reliability of estimates of the coefficient of variation for rare outcomes.ResultsEstimates of intracluster correlation for mortality outcomes were lower than those for process outcomes, with narrower confidence intervals throughout for trials with larger numbers of clusters. Estimates of intracluster correlation for maternal mortality were particularly variable with large confidence intervals. Stratified randomisation had the effect of reducing estimates of intracluster correlation. The simulation exercise showed that estimates of intracluster correlation are much less reliable for rare outcomes such as maternal mortality. The size of the cluster had a greater impact than the number of clusters on the reliability of estimates for rare outcomes.ConclusionsThe breadth of intracluster correlation estimates reported here in terms of outcomes and contexts will help researchers plan future community-based public health interventions around maternal and newborn health. Our study confirms previous work finding that estimates of intracluster correlation are associated with the prevalence of the outcome of interest, the nature of the outcome of interest (mortality or behavioural) and the size and number of clusters. Estimates of intracluster correlation for maternal mortality need to be treated with caution and a range of estimates should be used in planning future trials.

BackgroundMaternal common mental disorders are prevalent in low-resource settings and have far-reaching consequences for maternal and child health. We assessed the prevalence and predictors of psychological distress as a proxy for common mental disorders among mothers in rural Jharkhand and Orissa, eastern India, where over 40% of the population live below the poverty line and access to reproductive and mental health services is low.MethodWe screened 5801 mothers around 6 weeks after delivery using the Kessler-10 item scale, and identified predictors of distress using multiple hierarchical logistic regression.Results11.5% (95% CI: 10.7–12.3) of mothers had symptoms of distress (K10 score > 15). High maternal age, low asset ownership, health problems in the antepartum, delivery or postpartum periods, caesarean section, an unwanted pregnancy for the mother, small perceived infant size and a stillbirth or neonatal death were all independently associated with an increased risk of distress. The loss of an infant or an unwanted pregnancy increased the risk of distress considerably (AORs: 7.06 95% CI: 5.51–9.04 and 1.49, 95% CI: 1.12–1.97, respectively).LimitationsWe did not collect data on antepartum depression, domestic violence or a mother's past birth history, and were therefore unable to examine the importance of these factors as predictors of psychological distress.ConclusionsMothers living in underserved areas of India who experience infant loss, an unwanted pregnancy, health problems in the perinatal and postpartum periods and socio-economic disadvantage are at increased risk of distress and require access to reproductive healthcare with integrated mental health interventions.