An interventional study of Sumadhur and Multiple micronutrient supplement MMS in Anemia, Iron-Deficiency, Nutritional Deficiencies and Adherence, sponsored by University of California, San Francisco. Recruiting at 1 site in Nepal. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
Preconception micronutrient status (including anemia) is a critical determinant of maternal, newborn, and child health that remains undervalued in Nepal. However, providing micronutrient supplements (MMS) alone is not enough. In the Nepali context, the gap between marriage and the first birth is short and newly married women have the lowest household status. Addressing the intersectional barriers to health for newly married women, including inequitable gender norms and women's empowerment, household relationships, nutrition knowledge and practices-is essential for improving maternal and infant outcomes in Nepal. To mitigate the community, household, and individual factors resulting in poor nutrition, the team developed and pilot-tested an educational group intervention (Sumadhur, meaning "Best Relationship") for newly married women, husbands, and mothers-in-law triads. Sumadhur aims to provide information on nutrition and women's health, address inequitable gender norms and practices, strengthen household relationships and communication, and improve the household status of newly married women. The pilot study of Sumadhur brought triads of several households together for 16 interrelated sessions over four-months. Findings suggest that participants (N=90) found the intervention to be highly feasible and acceptable and nutritional norms and practices improved.
We propose to test the effectiveness of Sumadhur on maternal health and nutrition outcomes using a 2-arm cluster RCT (cRCT). The intervention participants will receive the Sumadhur group intervention and will be provided MMS directly at group sessions. In control villages who do not receive the Sumadhur group intervention, we will facilitate access to MMS at primary health centers. We will randomize 70 villages to each arm (with one group per village). Each village has one group of five women (total of 700 women). Newly married women, their husbands and mothers-in-laws (total=2,100), will be followed four times for 18 months post-intervention through surveys, hemoglobin tests and blood draws (women only). The specific aims are to estimate the effectiveness of Sumadhur on women's anemia and micronutrient status, including the cost-benefit of the intervention (Aim 1); explore the impact on intermediate outcomes such as gender norms, household relationships and eating practices and characterize the individual and household-level mechanisms of impact (Aim 2); understand triadic experiences and impact over time of Sumadhur (Aim 3).
Accomplishing these aims will provide evidence for how to improve micronutrient and anemia status among women before they become pregnant-thereby ensuring that women are not deficient in the critical early phases of pregnancy. These findings will also advance the field by testing novel approaches (household and community level behavior and norm change intervention) that, when combined with supplements, may lead to better adherence, uptake, and, ultimately, health outcomes, and have additional longer-term benefits.
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.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's planned enrollment of 2,100 is above the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will receive the standard of care and the intervention at the end of the study period
Sumadhur is a 4-month intervention with weekly sessions that last about 1.5 hours. Newly married women, their husbands and mothers-in-law gather with other household triads (5 households per group for a total of 15 people per group). Intervention participants will also receive multiple micronutritent supplements (MMS)
Behavioral: Sumadhur · Dietary Supplement: Multiple micronutrient supplement MMS
Sumadhur is a 4-month intervention with weekly sessions that last about 1.5 hours. Newly married women, their husbands and mothers-in-law gather with other household triads (5 households per group for a total of 15 people per group).
Multiple micronutrient supplement MMS provided in 180 pill bottles
Participants with Anemia
Participants with hemoglobin \<12g/dL or \<11g/dL if pregnant will be considered anemic
Time frame: 6 months
Participants with deficiencies/insufficiencies in selected micronutrients
Participants with deficiencies in the following micronutrients: iron, vitamin B12, and folate
Time frame: 6 months
Body max index
Body Mass Index measured with weight in kilograms over height in cm
Time frame: 18 months
Pregnancy status
Self reported pregnancy, measured using date of last menstrual period
Time frame: 18 months
Plan to share: No
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