Healthy Baby Healthy Mother Toolkit

NCT06594419 | Recruiting

• 1 other identifier: STUDY00006236
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Maternal Nutrition; Child Nutrition

Keywords

Healthy Mother Healthy Baby Toolkit; Maternal nutrition; Health Belief Model

Outcome Measures

Primary Outcomes (2)

• Maternal Weight gain during pregnancy

  Maternal weight is measured using a high quality electronic scale (precision 0.10 kg)- SECA (UNICEF).

  Baseline, third trimester

• Infant Birth Weight

  Infant birthweight will be collected as soon as possible after birth and at most within one week of birth. Birth weight captured by nurses immediately after delivery will be collected from health registers if the mother delivers in the facility, from the Antenatal care (ANC) card or by Research Assistants (RA) if she delivers at home

  At the time of birth

Secondary Outcomes (9)

• Infant Weight for age z scores

  7 days post birth, 4 months post birth, 9 months post birth

• Infant Length for age Z scores

  7 days post birth, 4 months post birth, 9 months post birth

• Infant Weight for Length Z scores

  7 days post birth, 4 months post birth, 9 months post birth

• Maternal Anthropometry: Mid-upper arm circumference

  Baseline, Late pregnancy (32-42 weeks of gestation), 4 months, 9 months postpartum

• Maternal Anthropometry: Height

  Baseline

Study Arms (2)

Healthy Mother Healthy Baby Toolkit

EXPERIMENTAL

297 women will be enrolled in this arm.

Behavioral: Healthy Mother Healthy Baby Toolkit

Standard of Care

ACTIVE COMPARATOR

297 women will be enrolled in this arm.

Other: Standard of care

Interventions

Healthy Mother Healthy Baby Toolkit BEHAVIORAL

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

Healthy Mother Healthy Baby Toolkit

Standard of care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \<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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Agency Fund and GDI solutions, LLC: collaborator
• Amharic Public Health Institute (APHI): collaborator

Study Sites (2)

Emory University in Ethiopia

Bahir Dar, Amhara, Ethiopia

RECRUITING

Bahir Dar City Zone Health Department

Bahir Dar, Woreda, Ethiopia

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amy Webb Girard, PhD BSN

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Webb Girard, PhD BSN

CONTACT

404-727-8807; awebb3@emory.edu

Moses Ekwueme, MSc

CONTACT

moses.ekwueme@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: November 27, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

ET (2)