Healthy Baby Healthy Mother Toolkit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorEmory University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
<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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Healthy Mother Healthy Baby Toolkit
BehavioralCustomized 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 interventionThe 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.
Treatment groups
594 Participants
are divided into 2 treatment groupsGroup A: Healthy Mother Healthy Baby ToolkitExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maternal Weight gain during pregnancy
Maternal weight is measured using a high quality electronic scale (precision 0.10 kg)- SECA (UNICEF).
Time frame
Baseline, third trimester2
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
Time frame
At the time of birthSecondary outcomes
1
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.
Time frame
7 days post birth, 4 months post birth, 9 months post birth2
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.
Time frame
7 days post birth, 4 months post birth, 9 months post birth3
Infant Weight for Length Z scores
Infant weight and length will be used to estimate z scores following WHO guidelines
Time frame
7 days post birth, 4 months post birth, 9 months post birth4
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.
Time frame
Baseline, Late pregnancy (32-42 weeks of gestation), 4 months, 9 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Agency Fund and GDI solutions, LLC
Collaborator
Amharic Public Health Institute (APHI)
Collaborator
Source ClinicalTrials.gov