Healthy Baby Healthy Mother Toolkit

Official title

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

Overview

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.

Interventions

• 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 n
• 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.

Primary outcome measures

• Maternal Weight gain during pregnancy [Time frame: Baseline, third trimester]
• Infant Birth Weight [Time frame: At the time of birth]

Secondary outcome measures (9)

• Infant Weight for age z scores [Time frame: 7 days post birth, 4 months post birth, 9 months post birth]
• Infant Length for age Z scores [Time frame: 7 days post birth, 4 months post birth, 9 months post birth]
• Infant Weight for Length Z scores [Time frame: 7 days post birth, 4 months post birth, 9 months post birth]
• Maternal Anthropometry: Mid-upper arm circumference [Time frame: Baseline, Late pregnancy (32-42 weeks of gestation), 4 months, 9 months postpartum]
• Maternal Anthropometry: Height [Time frame: Baseline]
• Maternal Dietary Data [Time frame: Baseline, Third trimester, 4 months post partum, 9 months postpartum]
• Women's dietary diversity scores [Time frame: Baseline, third trimester, 4 months post partum and 9 months post partum]
• Minimum acceptable diet [Time frame: within 1 week of delivery, 4 months post birth, 9 months post birth]
• Exclusive breastfeeding [Time frame: 1 week postpartum, 4 months postpartum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Ethiopia · 2 centers

• Emory University in Ethiopia — Bahir Dar
• Bahir Dar City Zone Health Department — Bahir Dar

Identifiers

NCT: NCT06594419 · STUDY00006236

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗