The Health Effects of Antenatal Multiple Micronutrient Supplementation in Nepalese Children.

Objectives: In low- and middle-income countries, prenatal multiple micronutrient supplementation has been shown in meta-analyses to increase birthweight and reduce the proportion of babies born small-for-gestational-age, but the longer term effects are unclear. We examined phenotypic and health differences between children born to mothers in a randomized controlled trial of prenatal multiple micronutrient (UNIMAPP) supplementation compared to iron and folate. Methods: The study was conducted in Dhanusha district, Nepal. We measured anthropometry, body composition using bioelectrical impedance (with population-specific isotope calibration), blood pressure, kidney dimensions by ultrasound, and spirometry. Health outcomes were recorded in questionnaires. Personal estimates of air pollution exposure (particles of less than 4 micrometers in size) were produced by microenvironment sampling. Results: We saw 841 children (80% of total), at a mean age of 8.5 years. The unadjusted mean (95%CI) difference (intervention minus control) in weight-for-age was 0.05 z-scores (-0.09,0.19), in height-for-age 0.02 z-scores (-0.10,0.15) and in BMI-for-age 0.04 z-scores (-0.09,0.18). Similar results were obtained from multi-variable regression analysis. No difference was found in body composition, kidney size, blood pressure or lung function. In addition there were no differences in health outcomes between allocation groups. Conclusions: Differences that were previously seen in phenotype and blood pressure at birth and at two years in children born to mothers who received antenatal UNIMMAP supplements were not apparent at 8.5 years of age. While not ruling out physiological differences and health benefits in adulthood, our findings do not suggest sustained effects of antenatal micronutrient supplementation.

MaiMwana Women's Groups: a Community Mobilisation Intervention to Improve Mother and Child Health and Reduce Mortality in Rural Malawi

This article presents a detailed description of a community mobilization intervention involving women's groups in Mchinji District; Malawi. The intervention was implemented between 2005 and 2010. The intervention aims to build the capacities of communities to take control of the mother and child health issues that affect them. To achieve this it comprises trained local female facilitators establishing groups and using a manual; participatory rural appraisal tools and picture cards to guide them through a community action cycle to identify and implement solutions to mother and child health problems. Significant resource inputs include salaries for facilitators and supervisors; and training; equipment and materials to support their work with groups. It is hypothesized that the groups will catalyse community collective action to address mother and child health issues and improve the health and reduce the mortality of mothers and children. Their impact; implementation and cost-effectiveness have been rigorously evaluated through a randomized controlled trial design. The results of these evaluations will be reported in 2011

Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia

Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of ­ and responsibility for ­ group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.