Healthy Baby Healthy Mother Toolkit

NCT ID: NCT06594419

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 594 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-27
• Study Completion Date: 2026-04-30

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

Detailed Description

The high burden of undernutrition through the critical first 1,000 days persists in Ethiopia. Studies have indicated that approximately 1 in 4 women of reproductive age in Ethiopia are underweight, 17% of babies are born at low birth weight and nearly 50% of children are stunted by age 2. Inadequate diets of pregnant and breastfeeding women, both suboptimal quality and quantity, are a key contributor to maternal and infant undernutrition in Ethiopia.

The National Nutrition Strategy of Ethiopia, adopted in 2008, recommends one additional meal per day to support healthy pregnancy, and two extra meals per day to support lactation (US Agency for International Development (USAID), 2008).

Using the Health Belief Model for behavior change, the study team developed and has tested in other contexts a Healthy Baby Toolkit (HBT) designed to serve as a cue to action to improve maternal and family self-efficacy in providing mothers and their babies with adequate nutrition. The toolkit has previously been tested in India, Kenya, Malawi, and Ethiopia where it has demonstrated acceptability and feasibility, and demonstrated improvement in the diets of children between 6-23 months. This new trial aims to understand the added health benefits of introducing the toolkit to mothers during pregnancy and the early postpartum period when crucial child growth and development trajectories are established.

The study will evaluate the benefits of HBT on maternal nutrition and infant growth, especially during the first 500 days (pregnancy and first 6 months of life). It will also assess strategies for facility and community-based delivery of the toolkit for future rollout and scaling up. Findings from this study will create an evidence base for effective counseling strategies and support advocacy efforts to integrate the toolkit into routine nutrition education and counseling programs in Ethiopia.

Conditions

Maternal Nutrition; Child Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Mother Healthy Baby Toolkit

297 women will be enrolled in this arm.

Group Type: EXPERIMENTAL

Healthy Mother Healthy Baby Toolkit

Intervention Type: 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

Standard of Care

297 women will be enrolled in this arm.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: 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.

Interventions

Healthy 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

Intervention Type: BEHAVIORAL

Standard 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Agency Fund and GDI solutions, LLC

UNKNOWN

Sponsor Role: collaborator

Amharic Public Health Institute (APHI)

UNKNOWN

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Amy Webb Girard

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Webb Girard, PhD BSN

Role: PRINCIPAL_INVESTIGATOR

Rollins School of Public Health

Locations

Emory University in Ethiopia

Bahir Dar, Amhara, Ethiopia

Site Status: RECRUITING

Bahir Dar City Zone Health Department

Bahir Dar, Woreda, Ethiopia

Site Status: RECRUITING

Countries

Ethiopia

Central Contacts

Amy Webb Girard, PhD BSN

Role: CONTACT

awebb3@emory.edu

404-727-8807

Moses Ekwueme, MSc

Role: CONTACT

moses.ekwueme@emory.edu

Facility Contacts

Abebe Gobezayehu, MD

Role: primary

abebe.g.gobezayehu@emory.edu

Tamiru Kassa

Role: backup

ktamiru@yahoo.com

Mulusew Belew

Role: primary

lijmulusewb@gmail.com

Other Identifiers

STUDY00006236

Identifier Type: -

Identifier Source: org_study_id