Maternal NutritionNCT06594419
Healthy Baby Healthy Mother Toolkit
A study testing Healthy Mother Healthy Baby Toolkit in people with Maternal Nutrition and Child Nutrition, run by Emory University at 2 sites in Ethiopia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Nutrition, Child Nutrition
- What is being tested?
- Healthy Mother Healthy Baby Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- 2 sitesEthiopia
- Study dates
- 27 Nov 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- <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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Moses Ekwueme, MSc contact
Ethiopia2 sites, 2 recruiting
- Recruiting
Emory University in Ethiopia
Bahir Dar, Amhara
Abebe Gobezayehu, MD, abebe.g.gobezayehu@emory.edu
Tamiru Kassa, ktamiru@yahoo.com
- Recruiting
Bahir Dar City Zone Health Department
Bahir Dar, Woreda
Mulusew Belew, lijmulusewb@gmail.com
About this study
Official title: Efficacy of the Healthy Mother Healthy Baby Toolkit for Maternal and Child Nutrition in Ethiopia
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
Read the 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.
- Conditions
- Maternal Nutrition, Child Nutrition
- Being tested
- Healthy Mother Healthy Baby Toolkit, Standard of care
- Keywords
- Healthy Mother Healthy Baby Toolkit, Maternal nutrition, Health Belief Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Mother Healthy Baby ToolkitBehavioural
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Mother Healthy Baby Toolkit | Experimental | 297 women will be enrolled in this arm. Receives: Behavioral: Healthy Mother Healthy Baby Toolkit |
| Standard of Care | Active comparator | 297 women will be enrolled in this arm. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Weight gain during pregnancy
Maternal weight is measured using a high quality electronic scale (precision 0.10 kg)- SECA (UNICEF).
Measured: 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
Measured: At the time of birth
Secondary outcomes (9)
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.
Measured: 7 days post birth, 4 months post birth, 9 months post birth
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 1 week postpartum, 4 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Nov 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal NutritionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency Fund and GDI solutions, LLC, Amharic Public Health Institute (APHI)
- Responsible party
- Principal investigator, Amy Webb Girard, Emory University
- Investigators
- Amy Webb Girard, PhD BSN, Principal investigator, Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594419
- Sponsor's protocol ID
- STUDY00006236
- Status last verified
- Mar 2025
- First submitted
- 27 Aug 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Healthy Mother Healthy Baby Toolkit for Maternal and Child Nutrition in Ethiopia
- ClinicalTrials.gov ID
- NCT06594419
- Acronym / sponsor ID
- STUDY00006236
- Conditions
- Maternal Nutrition, Child Nutrition
- Keywords
- Healthy Mother Healthy Baby Toolkit, Maternal nutrition, Health Belief Model
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Agency Fund and GDI solutions, LLC, Amharic Public Health Institute (APHI)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Mother Healthy Baby Toolkit | Experimental | Behavioral: Healthy Mother Healthy Baby Toolkit297 women will be enrolled in this arm. |
| Standard of Care | Active comparator | Other: Standard of care297 women will be enrolled in this arm. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- <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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Mother Healthy Baby ToolkitCustomized 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 | Behavioural | Healthy Mother Healthy Baby Toolkit |
| Standard of careThe 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. | Other | Standard of Care |
Primary outcome
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).
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moses Ekwueme, MSc contact
Amy Webb Girard, PhD BSN principal investigator
Rollins School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Mother Healthy Baby Toolkit in people with Maternal Nutrition and Child Nutrition, run by Emory University at 2 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Webb Girard, PhD BSN (404-727-8807, awebb3@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Weight gain during pregnancy (time frame: Baseline, third trimester). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.