RecruitingNot ApplicableNCT06594419

Healthy Baby Healthy Mother Toolkit

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


Sponsor

Emory University

Enrollment

594 participants

Start Date

Nov 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of the research is to test whether integrating a mother-baby nutrition toolkit into routine antenatal care service can improve maternal and infant nutrition in Amhara, Ethiopia


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years

Inclusion Criteria3

  • \<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 Criteria5

  • 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

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Interventions

BEHAVIORALHealthy Mother Healthy Baby Toolkit

Customized bowl with markings to indicate the recommended amount of food that participants should consume in pregnancy and while exclusively breastfeeding in the first 6 months, as well as how much they should feed their babies at 6-8 months, 9-12 months, and 1-2 years respectively. The toolkit also includes a spoon used to test and ensure adequate thickness of the meals fed to infants \>6mos and a counseling card that indicates the frequency of meals, recommended food groups for meeting daily nutrient needs, and hand hygiene and hygienic food preparation

OTHERStandard of care

The Ethiopian government and Saving Little Lives Initiative (SLL) standard of care includes maternal and infant nutrition education and counseling, iron and folic acid supplementation, as well as training on effective Kangaroo Mother Care (KMC), primarily defined as exclusive breastfeeding and skin-to-skin contact ≥ 8 hours per day-in the event of Low birth weight (LBW) or preterm delivery.


Locations(2)

Emory University in Ethiopia

Bahir Dar, Amhara, Ethiopia

Bahir Dar City Zone Health Department

Bahir Dar, Woreda, Ethiopia

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NCT06594419


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