Clinical trial NCT06594419: Healthy Baby Healthy Mother Toolkit
Official title: Efficacy of the Healthy Mother Healthy Baby Toolkit for Maternal and Child Nutrition in Ethiopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Nutrition
Child Nutrition
Keywords: Healthy Mother Healthy Baby Toolkit
Maternal nutrition
Health Belief Model
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Agency Fund and GDI solutions, LLC
name: Amharic Public Health Institute (APHI)
First posted: 2024-09-19
Enrollment: 594
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Maternal Weight gain during pregnancy
timeFrame: Baseline, third trimester
measure: Infant Birth Weight
timeFrame: At the time of birth
Secondary outcomes:
measure: Infant Weight for age z scores
timeFrame: 7 days post birth, 4 months post birth, 9 months post birth
measure: Infant Length for age Z scores
timeFrame: 7 days post birth, 4 months post birth, 9 months post birth
measure: Infant Weight for Length Z scores
timeFrame: 7 days post birth, 4 months post birth, 9 months post birth
measure: Maternal Anthropometry: Mid-upper arm circumference
timeFrame: Baseline, Late pregnancy (32-42 weeks of gestation), 4 months, 9 months postpartum
measure: Maternal Anthropometry: Height
timeFrame: Baseline
measure: Maternal Dietary Data
timeFrame: Baseline, Third trimester, 4 months post partum, 9 months postpartum
measure: Women's dietary diversity scores
timeFrame: Baseline, third trimester, 4 months post partum and 9 months post partum
measure: Minimum acceptable diet
timeFrame: within 1 week of delivery, 4 months post birth, 9 months post birth
measure: Exclusive breastfeeding
timeFrame: 1 week postpartum, 4 months postpartum
Other outcomes:
Locations:
city: Bahir Dar
country: Ethiopia
facility: Emory University in Ethiopia
state: Amhara
city: Bahir Dar
country: Ethiopia
facility: Bahir Dar City Zone Health Department
state: Woreda
Study officials:
affiliation: Rollins School of Public Health
name: Amy Webb Girard, PhD BSN
role: PRINCIPAL_INVESTIGATOR
References: