Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
FEMALE
Healthy Volunteers
ID06594419

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

Age: 18Years - 35Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

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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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Frequently Asked Questions

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