Actively Recruiting
Efficacy of the Healthy Mother Healthy Baby Toolkit for Maternal and Child Nutrition in Ethiopia
Led by Emory University · Updated on 2025-03-24
594
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
A
Agency Fund and GDI solutions, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether adding a mother-baby nutrition toolkit to routine prenatal care can improve nutrition for mothers and infants in Amhara, Ethiopia. It addresses the high rates of undernutrition seen in Ethiopian women and children, focusing on the first 1,000 days from pregnancy through early childhood. The study is designed to assess the impact of this toolkit on maternal nutrition and infant growth during pregnancy and the first six months of life, providing evidence to support better nutrition counseling strategies. The study involves two groups: one receives the Healthy Mother Healthy Baby Toolkit, which includes a customized bowl with portion markings, a spoon for meal thickness assessment, and a counseling card about meal frequency, food groups, and hygiene; the other group receives the standard nutrition education, counseling, and supplementation provided by the Ethiopian government and the Saving Little Lives Initiative. The toolkit is given during pregnancy and early postpartum, with the study lasting through the infant's first 10 months. Participants will be monitored at various stages, including early pregnancy, late pregnancy, and multiple postpartum time points. Researchers will measure maternal weight gain, infant birth weight, infant growth scores, maternal arm circumference and height, dietary diversity, breastfeeding exclusivity, and feeding adequacy. Data collection includes baseline assessments and follow-ups at birth, 7 days, 4 months, and 9 months after birth. The study will last until April 2026, with ongoing evaluation of nutrition and growth outcomes.
CONDITIONS
Brief Title
Healthy Baby Healthy Mother Toolkit
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Less than 20 weeks pregnant based on last menstrual period
- Plans to breastfeed and provide age-appropriate complementary feeding
- Intends to continue care at the enrolling health center until infant is at least 10 months old
- Female aged 18 to 35 years
You will not qualify if you...
- Participation in the formative phase of the Healthy Mother Healthy Baby Toolkit project
- Existing medical conditions posing high-risk pregnancy such as uncontrolled diabetes, advanced kidney disease, thyroid disease, autoimmune disorders, rheumatoid arthritis, organ transplant, blood clotting disorders, or multiple sclerosis
- History of previous very preterm delivery (less than 32 weeks) or very low birth weight babies (less than 1.5 kg)
- Known serious obstetric complications including multiple miscarriages or stillbirths (more than 2), eclampsia, hemorrhage, placenta previa, placental abruption, or uterine rupture
- Pregnancy loss, neonatal or infant mortality (excluded from further follow-up)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment during pregnancy until 6 months postpartum
Participants receive the Healthy Mother Healthy Baby Toolkit or standard of care to support maternal nutrition during pregnancy and infant nutrition through the first 6 months after birth.
Regular visits throughout pregnancy and first 6 months postpartum
Trial Site Locations
Total: 2 locations
1
Emory University in Ethiopia
Bahir Dar, Amhara, Ethiopia
Actively Recruiting
2
Bahir Dar City Zone Health Department
Bahir Dar, Woreda, Ethiopia
Actively Recruiting
Research Team
A
Amy Webb Girard, PhD BSN
M
Moses Ekwueme, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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