Clinical trial Recruiting at 2 sites Interventional Ages 18 to 35 Women only

Nutrition toolkit for mothers and babies in Ethiopia

Official title: Efficacy of the Healthy Mother Healthy Baby Toolkit for Maternal and Child Nutrition in Ethiopia

Run by Emory University · NCT06594419 · Data updated 2026-11-12

This study is testing a Healthy Baby Toolkit to see if it can help mothers in Ethiopia improve their nutrition during pregnancy and after childbirth, which may also benefit their babies' growth.

More Maternal Nutrition trials

Quick facts

Study typeInterventional
Ages18 Years to 35 Years
SexWomen only
Enrollment594 (estimated)
SponsorEmory University
Academic / other
Locations2 sites (Bahir Dar, Amhara and 1 other locations)
StatusRecruiting
StartedNovember 27, 2024
Main results expectedApril 2026
Study endsApril 2026
Registry record updatedMarch 24, 2025
Trial IDNCT06594419 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are pregnant women under 20 weeks gestation who intend to breastfeed and provide appropriate complementary feeding.

Probably not a fit

Patients with high-risk pregnancies or serious medical conditions that could independently affect study outcomes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to evaluate the effectiveness of a Healthy Baby Toolkit integrated into routine antenatal care to enhance maternal and infant nutrition in Amhara, Ethiopia. The study addresses the high rates of undernutrition among women and children in the region, focusing on improving dietary practices during pregnancy and early postpartum. Utilizing the Health Belief Model, the toolkit is designed to empower mothers with knowledge and resources to ensure adequate nutrition for themselves and their infants. The trial will assess the impact of this intervention on maternal nutrition and infant growth outcomes.

Why it matters

Potential benefit: If successful, this intervention could significantly improve nutritional outcomes for mothers and infants, reducing rates of undernutrition in Ethiopia.

How similar studies have gone: Previous studies using similar nutrition toolkit approaches in other countries have shown promising results in improving maternal and child nutrition.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* \<20 weeks gestation as determined by maternal report of last menstrual period
* Intending to breastfeed and provide age-appropriate complementary feeding
* Intend to continue services at the health center where they enrolled until their infant is at least 10 months old

Exclusion Criteria:

* Women who participated in the formative phase of the HMHBT project
* Women with an existing medical condition that merits precautions for a high-risk pregnancy and may affect study outcomes independently of the intervention. These include for example, uncontrolled or advanced diabetes, advanced kidney disease (stage 3 or higher); thyroid disease, autoimmune disorders such as lupus, moderate to severe rheumatoid arthritis, organ transplant; blood clotting or bleeding disorders, multiple sclerosis.
* Women with a history of previous preterm delivery (\<32w) or very low birth weight babies (\<1.5kg)
* Known history of serious obstetric complications that place the mother at increased risk for subsequent adverse events or complications. These include for example multiple miscarriages or stillbirths (\>2); eclampsia, hemorrhage, placenta previa, placental abruption, uterine rupture
* Women experiencing pregnancy loss, and neonatal or infant mortality will be excluded from further follow-up. Women who give birth to multiples will be retained but their data will be analyzed separately

Where it's running

  • Emory University in Ethiopia
    Bahir Dar, Amhara, Ethiopia
    Recruiting
  • Bahir Dar City Zone Health Department
    Bahir Dar, Woreda, Ethiopia
    Recruiting

Study contacts

  • Principal investigator: Amy Webb Girard, PhD BSN — Rollins School of Public Health
  • Study coordinator: Amy Webb Girard, PhD BSN
  • Email: awebb3@emory.edu
  • Phone: 404-727-8807

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.