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NCT Number: NCT06594419

Healthy Baby Healthy Mother Toolkit

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory University in Ethiopia, Bahir Dar, Amhara, Ethiopia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Maternal Weight gain during pregnancy

    Time frame: Baseline, third trimester

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

  2. Infant Birth Weight

    Time frame: At the time of birth

    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

Secondary outcomes

  1. Infant Weight for age z scores

    Time frame: 7 days post birth, 4 months post birth, 9 months post birth

    Naked or near naked weight is measured using a SECA taring, mother baby scale accurate to 10 g. Readings are made to the nearest 10 g.

    Weight and age in months will be used to estimate weight for age z scores following WHO guidelines.

  2. Infant Length for age Z scores

    Time frame: 7 days post birth, 4 months post birth, 9 months post birth

    Recumbent length is measured using a wooden Schorr measuring board by two trained researchers. One applies gentle traction to bring the crown of the child's head into contact with the fixed headboard; the second holds the baby's feet, without shoes and with toes pointing directly upward, and keeping the knees straight, brings the movable footboard to rest firmly against the heels.

    Length and age in months will be used to estimate length for age z scores following WHO guidelines.

  3. Infant Weight for Length Z scores

    Time frame: 7 days post birth, 4 months post birth, 9 months post birth

    Infant weight and length will be used to estimate z scores following WHO guidelines

  4. Maternal Anthropometry: Mid-upper arm circumference

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

    Women's mid-upper-arm circumference (MUAC) is measured at enrollment and again at every follow-up period delivery. MUAC is measured using a flexible, non-stretchable tape at the mid-point of the non dominant upper arm, between the acromion process and the tip of the olecranon. The measurement is taken to the nearest mm.

  5. Maternal Anthropometry: Height

    Time frame: Baseline

    A standardized stadiometer is employed, ensuring precision to the nearest 0.1 cm. Women are measured without shoes, wearing light clothing, and with the spine erect and heels together. The measurement is taken from the crown of the head to the bottom of the feet.

  6. Maternal Dietary Data

    Time frame: Baseline, Third trimester, 4 months post partum, 9 months postpartum

    Energy (Kcal/ day) and protein intakes and dietary patterns of participating women will be assessed using a food frequency questionnaire that queries the frequency of consumption and portion size of approximately 80-120 foods over the previous 30 days.

    The 24hr recall will utilize food scales, common utensils (e.g., traditional spoons and bowls, the Healthy Mother Healthy Baby Toolkit (HMHBT) cups), food pictures, and standardized recipes to assist in estimating food amounts (in grams) consumed by pregnant / breastfeeding women

  7. Women's dietary diversity scores

    Time frame: Baseline, third trimester, 4 months post partum and 9 months post partum

    Percentage of women meeting minimum dietary diversity from enrollment through 9month postpartum

  8. Minimum acceptable diet

    Time frame: within 1 week of delivery, 4 months post birth, 9 months post birth

    Summary indicator of infant diet quality assessed at 9 months of age using WHO-approved and validated indicators following a 24-hour recall approach. This outcome is an aggregate indicator comprised of three separate indicators including meeting minimum dietary diversity, minimum meal frequency, and age-appropriate breastfeeding

  9. Exclusive breastfeeding

    Time frame: 1 week postpartum, 4 months postpartum

    A WHO-approved and validated survey tool will be used based on a 24-hour recall of fluids and food intake.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Webb Girard, PhD BSN

CONTACT

[email protected]

404-727-8807

Moses Ekwueme, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Agency Fund and GDI solutions, LLC
  • Amharic Public Health Institute (APHI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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