Reducing Anemia Among Preconception Women in Nepal Through a Group Norm and Micronutrient Supplementation Intervention (Sumadhur)

Anemia and micronutrient (iron, folate, B12, zinc) deficiencies during pregnancy are a leading cause of maternal mortality and morbidity in South Asia and have intergenerational effects, contributing to low birth weight, preterm birth and perinatal mortality. Despite national efforts to provide iron-folic acid (IFA) supplements to pregnant women in Nepal for free, only 41% consume the recommended amount, and high levels of maternal anemia (52%) and micronutrient deficiencies persist. Provision of micronutrient supplements is necessary but not sufficient-intersectional social and behavioral factors also must be addressed. Furthermore, micronutrient status needs to be improved during the preconception period to impact the important first trimester (before most women in Nepal typically seek care) to improve maternal and infant outcomes to the greatest extent possible. With short gaps between marriage and first pregnancy, newly married women should be a focal population. National health and nutrition programs do not currently provide micronutrient supplementation (MMS) to preconception women nor do they mitigate the structural, social, and behavioral (ecological) factors.

Several barriers to adequate nutrition and potential uptake of MMS have been identified. Inequitable gender norms limit women's access to nutrition and health care in South Asia, where women, especially young and newly married, have low levels of empowerment. Women's limited agency in the household and community lead women to have poor dietary diversity, low consumption of micronutrient-rich foods and seek antenatal care late. Household food insecurity and incomplete nutrition knowledge also contribute to women's poor nutritional status preconception and in pregnancy. Hence, engaging other household members (husbands and in-laws) and addressing broader issues around women's status are key to reducing anemia and improving micronutrient status. To address these barriers, interventions engaging multiple household members are necessary to shift norms and promote healthy behavior change, in addition to providing information and access to MMS. Formative research in rural Nepal (K01HD086281) found that newly married women, their husbands, and mothers-in-law ("triads") desired information about nutrition and maternal health. Investigators found that young (\<25 years) newly married women often ate last and had low dietary diversity, and positive household relationships were associated with enhanced access to nutritious foods. Thus, in collaboration with local community partners, the investigators developed Sumadhur, a 4-month group intervention that covers preconception and pregnancy nutrition, household eating patterns, anemia, maternal healthcare seeking, gender norms and inequality, and couples/household relationship dynamics. Triads met weekly with other triads (5 households per group=15 people per group). Pilot data from six groups (N=90 participants) found Sumadhur to be acceptable and feasible (83% attended \>80% of sessions) and showed preliminary evidence of changes in nutrition norms and practices.8 Based on these promising preliminary findings, the investigators propose to test the effectiveness of Sumadhur on maternal health and nutrition outcomes using a 2-arm cluster randomized controlled trial. Intervention participants will receive the Sumadhur group intervention and be provided MMS directly at group sessions whereas MMS will be freely available at primary health centers in control villages. The investigators will randomize 70 villages to each arm (140 villages total). Each village will have one group of \~5 newly married women, their husbands and mothers-in-laws (N=2,100), who will be followed every 4-6 months for 18-months post-intervention through surveys, hemoglobin assessments and blood draws (women only). The investigators will conduct concurrent in-depth longitudinal qualitative interviews (LQIs) with a sub-set of triads at each data collection time points.

Aim 1: To estimate the effectiveness of Sumadhur on newly married women's anemia and micronutrient deficiency. The primary effectiveness outcomes are the prevalence of anemia (hemoglobin \<12g/dL or \<11g/dL if pregnant) and deficiencies/insufficiencies in selected micronutrients: iron, zinc, vitamin B12, and folate (1a).

Secondary outcomes include reproductive, pregnancy/maternal and infant health behaviors and outcomes. The investigators will also determine the cost per disability-adjusted life year averted of the intervention to inform scale-up (1b).

Aim 2: To estimate the (a) effectiveness and (b) mechanism of impact of Sumadhur on intermediary outcomes that may be on the causal path to improved anemia and micronutrient status. The primary outcomes for aim 2a are: (1) social and gender norms, (2) women's empowerment, (3) nutrition and maternal health knowledge, and (4) household relationships and eating patterns, using data collected from all members of triads. In 2b, the investigators will delineate the pathways through which Sumadhur operates, including changing intermediary outcomes and MMS adherence using mediation analyses to identify drivers of intervention impact.

Aim 3: Understand triadic experiences and impact over time of Sumadhur. Using a convergent parallel analysis design, the investigators will uncover explanations for these quantitative findings from multiple perspectives using triadic longitudinal IDI data from newly married women, their husbands, and mothers-in-law.

The investigators' findings will inform programs and policies aiming to reduce anemia and micronutrient deficiencies, which are key contributors to excess maternal, newborn, and child morbidity and mortality globally. This work will lay the groundwork for potential implementation studies of the scale-up and integration into Nepal's National Policy.