Multiple-micronutrient supplementation for women during pregnancy.
Emily C Keats, Batool A Haider, Emily Tam...
https://pubmed.ncbi.nlm.nih.gov/30873598Actively Recruiting
Phase Not Applicable
Age: 18Years - 25Years
FEMALE
Healthy Volunteers
ID06810440
Reducing Anemia Among Young Preconception Women in Nepal Through a Group Household Norm and Micronutrient Supplementation Intervention
Led by University of California, San Francisco · Updated on 2026-03-30
2100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates anemia and micronutrient deficiencies among newly married women under 25 in Nepal, focusing on improving maternal and infant health outcomes through a combined group intervention and supplement approach. The study aims to address social and behavioral barriers like gender norms and household dynamics that affect nutrition and health, using a cluster randomized controlled trial to evaluate these effects. The intervention builds on promising pilot results of the Sumadhur program, which supports nutrition, women's empowerment, and household communication. The study compares two groups in 140 villages: one receiving the Sumadhur intervention along with multiple micronutrient supplements (MMS) provided directly at weekly group sessions for four months, and a control group with access to MMS at local health centers without the group sessions. Sumadhur involves weekly 1.5-hour meetings for triads of newly married women, their husbands, and mothers-in-law, aiming to improve nutrition knowledge, gender norms, and household relationships. Participants will be followed for 18 months after the intervention, with data collection every 4 to 6 months including surveys, hemoglobin tests, and blood draws for micronutrient analysis in women. Researchers will assess anemia prevalence and micronutrient deficiencies, along with social and behavioral factors like empowerment and nutrition practices. Qualitative interviews with household triads will provide insights into experiences and impacts over time, contributing to evidence for policy and program development.
CONDITIONS
Brief Title
Reducing Anemia Among Preconception Women in Nepal Through a Group Norm and Micronutrient Supplementation Intervention
Who Can Participate
Age: 18Years - 25Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Newly married couples married within the last four months
- Women under 25 years old
- Women never pregnant and not currently pregnant
- Living in the same household and sharing meals with mother-in-law
- All triad household members willing to participate
- Husbands not planning to migrate in the next 6 months
You will not qualify if you...
- Women under 18 or over 25 years old
- Currently or ever pregnant women
- Married more than 4 months prior
- Not co-residing with mother-in-law
- Unwillingness to participate
- Do not consent to blood draws
- Women with severe anemia (hemoglobin < 8.0 g/dL) at baseline
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Sumadhur Intervention
Duration - 4 months
Participants engage in a group intervention with weekly sessions lasting about 1.5 hours, focusing on nutrition, anemia, maternal health, gender norms, and household relationship dynamics. Newly married women, their husbands, and mothers-in-law meet with other household triads in groups.
Weekly sessions (in-person)
Micronutrient Supplementation
Duration - 4 months
Participants receive multiple micronutrient supplements (MMS) during the intervention period to improve anemia and micronutrient status.
Supplement provided at weekly group sessions
Follow-up Monitoring
Duration - 18 months
Participants are followed every 4 to 6 months for 18 months post-intervention to assess anemia, micronutrient status, and health outcomes through surveys and blood draws.
Visits every 4 to 6 months (in-person)
Trial Site Locations
Total: 1 location
1
Center for Research on Environment, Health and Population Activities (CREHPA)
Kathmandu, Nepal
Actively Recruiting
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Research Team
N
Nadia G Diamond-Smith, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Review of the evidence regarding the use of antenatal multiple micronutrient supplementation in low- and middle-income countries.
Megan W Bourassa, Saskia J M Osendarp, Seth Adu-Afarwuah...
https://pubmed.ncbi.nlm.nih.gov/31134643Addressing anaemia in pregnancy in rural plains Nepal: A qualitative, formative study.
Joanna Morrison, Romi Giri, Abriti Arjyal...
https://pubmed.ncbi.nlm.nih.gov/34241951Risk of maternal mortality in women with severe anaemia during pregnancy and post partum: a multilevel analysis.
Jahnavi Daru, Javier Zamora, Borja M Fernández-Félix...
https://pubmed.ncbi.nlm.nih.gov/29571592Maternal anemia and risk of adverse birth and health outcomes in low- and middle-income countries: systematic review and meta-analysis.
Md Mizanur Rahman, Sarah Krull Abe, Md Shafiur Rahman...
https://pubmed.ncbi.nlm.nih.gov/26739036Cluster 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.
Nadia Diamond-Smith, Mahesh C Puri, Lily Borak...
https://pubmed.ncbi.nlm.nih.gov/40713050