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

Recruiting now · Not applicable

Conditions studied: Anemia, Iron-Deficiency, Nutritional Deficiencies, Adherence, Norms, Social, Knowledge, Attitudes, Practice

In brief

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.

Key facts

Study ID: NCT06810440
Run by: University of California, San Francisco
People needed: 2100
Starts: 2025-10-08
Expected to finish: 2029-04-01
Last updated by the study team: 2026-03-30

Who can join

Age: 18 and older, up to 25. Sex: female. Healthy volunteers: accepted.

You may qualify if…

the newly married couple having been married in the last four months
women being under 25 years old
never pregnant and not currently pregnant
co-residing with the mother-in-law in a household as defined by sharing meals together.
all triad-household members must also be willing to participate
husbands must not be planning to migrate in the next 6 months.

You may not qualify if…

Over 25, under 18 years old
Currently or ever pregnant
married more than 4 months before
not co-residing
not being willing to participate.
do not consent to blood-draws
women who are severely anemic (hemoglobin < 8.0 g/dL) at baseline based on hemoglobin via Hemocue assessment of a fingerprick blood sample at the time of enrollment

Where it is running

Center for Research on Environment, Health and Population Activities (CREHPA) — Kathmandu, Nepal (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.