NCT06810440 Reducing Anemia Among Preconception Women in Nepal Through a Group Norm and Micronutrient Supplementation Intervention
| NCT ID | NCT06810440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Anemia, Iron-Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,100 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,100 participants in total. It began in 2025-10-08 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Nadia G Diamond-Smith, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06810440 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 25 Years, studying Anemia, Iron-Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06810440 currently recruiting?
Yes, NCT06810440 is actively recruiting participants. Contact the research team at nadia.diamond-smith@ucsf.edu for enrollment information.
Where is the NCT06810440 trial being conducted?
This trial is being conducted at Kathmandu, Nepal.
Who is sponsoring the NCT06810440 clinical trial?
NCT06810440 is sponsored by University of California, San Francisco. The principal investigator is Nadia G Diamond-Smith, PhD at University of California, San Francisco. The trial plans to enroll 2,100 participants.