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

NCT06810440 | Recruiting DMC

• 1 other identifier: R01HD114798
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Iron-Deficiency; Nutritional Deficiencies; Adherence; Norms, Social; Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (2)

• Participants with Anemia

  Participants with hemoglobin \<12g/dL or \<11g/dL if pregnant will be considered anemic

  6 months

• Participants with deficiencies/insufficiencies in selected micronutrients

  Participants with deficiencies in the following micronutrients: iron, vitamin B12, and folate

  6 months

Secondary Outcomes (2)

• Body max index

  18 months

• Pregnancy status

  18 months

Study Arms (2)

Control

NO INTERVENTION

This arm will receive the standard of care and the intervention at the end of the study period

Intervention

EXPERIMENTAL

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

Interventions

Multiple micronutrient supplement MMS DIETARY_SUPPLEMENT

Multiple micronutrient supplement MMS provided in 180 pill bottles

Intervention

Sumadhur BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Center for Research on Environment, Health and Population Activities: collaborator
• University of California, San Francisco: lead

Study Sites (1)

Center for Research on Environment, Health and Population Activities (CREHPA)

Kathmandu, Nepal

RECRUITING

Related Publications (6)

• Keats EC, Haider BA, Tam E, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2019 Mar 14;3(3):CD004905. doi: 10.1002/14651858.CD004905.pub6.

  PMID: 30873598 BACKGROUND

• Bourassa MW, Osendarp SJM, Adu-Afarwuah S, Ahmed S, Ajello C, Bergeron G, Black R, Christian P, Cousens S, de Pee S, Dewey KG, Arifeen SE, Engle-Stone R, Fleet A, Gernand AD, Hoddinott J, Klemm R, Kraemer K, Kupka R, McLean E, Moore SE, Neufeld LM, Persson LA, Rasmussen KM, Shankar AH, Smith E, Sudfeld CR, Udomkesmalee E, Vosti SA. Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries. Ann N Y Acad Sci. 2019 May;1444(1):6-21. doi: 10.1111/nyas.14121. Epub 2019 May 27.

  PMID: 31134643 BACKGROUND

• Morrison J, Giri R, Arjyal A, Kharel C, Harris-Fry H, James P, Baral S, Saville N, Hillman S. Addressing anaemia in pregnancy in rural plains Nepal: A qualitative, formative study. Matern Child Nutr. 2021 Jul;17 Suppl 1(Suppl 1):e13170. doi: 10.1111/mcn.13170.

  PMID: 34241951 BACKGROUND

• Daru J, Zamora J, Fernandez-Felix BM, Vogel J, Oladapo OT, Morisaki N, Tuncalp O, Torloni MR, Mittal S, Jayaratne K, Lumbiganon P, Togoobaatar G, Thangaratinam S, Khan KS. Risk of maternal mortality in women with severe anaemia during pregnancy and post partum: a multilevel analysis. Lancet Glob Health. 2018 May;6(5):e548-e554. doi: 10.1016/S2214-109X(18)30078-0. Epub 2018 Mar 20.

  PMID: 29571592 BACKGROUND

• Rahman MM, Abe SK, Rahman MS, Kanda M, Narita S, Bilano V, Ota E, Gilmour S, Shibuya K. Maternal anemia and risk of adverse birth and health outcomes in low- and middle-income countries: systematic review and meta-analysis. Am J Clin Nutr. 2016 Feb;103(2):495-504. doi: 10.3945/ajcn.115.107896. Epub 2016 Jan 6.

  PMID: 26739036 BACKGROUND

• Diamond-Smith N, Puri MC, Borak L, Walker D, Charlebois E, Weiser SD, McDonald CM. Cluster randomised controlled trial of a household-level, group preconception nutrition awareness and norm intervention (SUMADHUR) combined with multiple micronutrient supplements (MMS) for newly married households: a protocol. BMJ Open. 2025 Jul 25;15(7):e103488. doi: 10.1136/bmjopen-2025-103488.

  PMID: 40713050 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Malnutrition; Behavior

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders

Study Officials

• Nadia G Diamond-Smith, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia G Diamond-Smith, PhD

CONTACT

510 914 4586; nadia.diamond-smith@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 5, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)