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.

Moving beyond individual barriers and identifying multi-level strategies to reduce anemia in Odisha India.

BACKGROUND: To reduce the prevalence of anemia, the Indian government recommends daily iron and folic acid supplements (iron supplements) for pregnant women and weekly iron supplements for adolescents and all women of reproductive age. The government has distributed free iron supplements to adolescents and pregnant women for over four decades. However, initial uptake and adherence remain inadequate and non-pregnant women of reproductive age are largely ignored. The aim of this study is to examine the multilevel barriers to iron supplement use and to subsequently identify promising areas to intervene. METHODS: We conducted a qualitative study in the state of Odisha, India. Data collection included key informant interviews, focus group discussions with women, husbands, and mothers-in-law, and direct observations in health centers, pharmacies and village health and nutrition days. RESULTS: We found that at the individual level, participants knew that iron supplements prevent anemia but underestimated anemia prevalence and risk in their community. Participants also believed that taking too many iron supplements during pregnancy would "make your baby big" causing a painful birth and a costly cesarean section. At the interpersonal level, mothers-in-law were not supportive of their daughters-in-law taking regular iron supplements during pregnancy but husbands were more supportive. At the community level, participants reported that only pregnant women and adolescents are taking iron supplements, ignoring non-pregnant women altogether. Unequal gender norms are also an upstream barrier for non-pregnant women to prioritize their health to obtain iron supplements. At the policy level, frontline health workers distribute iron supplements to pregnant women only and do not follow up on adherence. CONCLUSIONS: Interventions should address multiple barriers to iron supplement use along the socio-ecological model. They should also be tailored to a woman's reproductive life course stage: adolescents, pregnancy, and non-pregnant women of reproductive age because social norms and available services differ between the subpopulations.