NCT06594419

Healthy Baby Healthy Mother Toolkit

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 594 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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
OTHER	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.

Timeline

• Start date: 2024-11-27
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-09-19
• Last updated: 2025-03-24

Locations

2 sites across 1 country: Ethiopia