The reduction in anemia through normative innovations (RANI) project: Study protocol for a cluster randomized controlled trial in Odisha, India

Background: More than half of women in India are anemic. Anemia can result in fatigue, poor work productivity, higher risk of pre-term delivery, and maternal mortality. The Indian government has promoted the use of iron-folic acid supplements (IFA) for the prevention and treatment of anemia for the past five decades, but uptake remains low and anemia prevalence high. Current programs target individual-level barriers among pregnant women and adolescents, but a more comprehensive approach that targets multiple levels among all women of reproductive age is needed to increase uptake of IFA and iron-rich foods. Methods: The Reduction in Anemia through Normative Innovations (RANI) project is a norms-based intervention to reduce anemia among women of reproductive age. We will evaluate the intervention through a clustered randomized controlled trial in Odisha, India. We will collect data at three time points (baseline, midline, and end line). For the study, we selected 89 clusters of villages, which we randomized into treatment and control on a 1:1 basis. The treatment arm will receive the RANI project components while the control arm will receive usual care. Fifteen clusters (40-41 villages) were selected and 4000 women (2000 in each arm) living in the selected clusters will be randomly selected to take part in data collection. Women in both study arms will have their hemoglobin concentrations measured. They will also complete in-person surveys about their knowledge, attitudes, perceptions of iron folic acid supplements, and nutritional intake. We will also select a smaller cohort of 300 non-pregnant women (150 in each arm) from this cohort for additional physical activity and cognitive testing. We will conduct both within- and between-group comparisons (treatment and control) at baseline, midline and end line using t-tests. We will also conduct structural equation modeling to examine how much each factor accounts for IFA use and hemoglobin levels. Discussion: This RCT will enable us to examine whether a social norms-based intervention can increase uptake of iron folic acid supplements and iron rich foods to reduce anemia. Trial registration: This trial was registered with Clinical Trial Registry- India (CTRI) (CTRI/2018/10/016186) on 29 October 2018.