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| Name | Class |
|---|---|
| Agency Fund and GDI solutions, LLC | UNKNOWN |
| Amharic Public Health Institute (APHI) | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Mother Healthy Baby Toolkit | Experimental | 297 women will be enrolled in this arm. |
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| Standard of Care | Active Comparator | 297 women will be enrolled in this arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Weight gain during pregnancy | Maternal weight is measured using a high quality electronic scale (precision 0.10 kg)- SECA (UNICEF). | Baseline, third trimester |
| Infant Birth Weight | 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 | At the time of birth |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Weight for age z scores | 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. | 7 days post birth, 4 months post birth, 9 months post birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Webb Girard, PhD BSN | Contact | 404-727-8807 | awebb3@emory.edu | |
| Moses Ekwueme, MSc | Contact | moses.ekwueme@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy Webb Girard, PhD BSN | Rollins School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University in Ethiopia | Recruiting | Bahir Dar | Amhara | Ethiopia |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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. |
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| Infant Length for age Z scores |
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. |
| 7 days post birth, 4 months post birth, 9 months post birth |
| Infant Weight for Length Z scores | Infant weight and length will be used to estimate z scores following WHO guidelines | 7 days post birth, 4 months post birth, 9 months post birth |
| Maternal Anthropometry: Mid-upper arm circumference | 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. | Baseline, Late pregnancy (32-42 weeks of gestation), 4 months, 9 months postpartum |
| Maternal Anthropometry: Height | 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. | Baseline |
| Maternal Dietary Data | 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 | Baseline, Third trimester, 4 months post partum, 9 months postpartum |
| Women's dietary diversity scores | Percentage of women meeting minimum dietary diversity from enrollment through 9month postpartum | Baseline, third trimester, 4 months post partum and 9 months post partum |
| Minimum acceptable diet | 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 | within 1 week of delivery, 4 months post birth, 9 months post birth |
| Exclusive breastfeeding | A WHO-approved and validated survey tool will be used based on a 24-hour recall of fluids and food intake. | 1 week postpartum, 4 months postpartum |
| Bahir Dar City Zone Health Department | Recruiting | Bahir Dar | Woreda | Ethiopia |
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