Nutrition toolkit for mothers and babies in Ethiopia
Efficacy of the Healthy Mother Healthy Baby Toolkit for Maternal and Child Nutrition in Ethiopia
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 594 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Emory University Academic / other |
| Locations | 2 sites (Bahir Dar, Amhara and 1 other locations) |
| Trial ID | NCT06594419 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women under 20 weeks gestation who intend to breastfeed and provide appropriate complementary feeding.
Not a fit: Patients with high-risk pregnancies or serious medical conditions that could independently affect study outcomes may not benefit from this study.
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 performed: Previous studies using similar nutrition toolkit approaches in other countries have shown promising results in improving maternal and child nutrition.
Eligibility criteria
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 this trial is running
Bahir Dar, Amhara and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.