The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi

Study Overview
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Brief Summary
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The Mazira Project is a study of the effect of egg consumption on growth, development and gut health of infants in Malawi. The study randomly assigns infants to receive one egg per day over six months or to receive an equivalent value of food at the end of six months. Growth, achievement of developmental milestones, gut microbiome composition and other measures of nutritional status are compared between the two groups to determine whether regular egg consumption benefits Malawian infants.

Detailed Description
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The aim of the Mazira Project is to determine whether daily consumption of an egg improves the growth and development of infants in rural Malawi. In Malawi, 37% of children under five years old are stunted, or shorter than expected for their age (1). Most stunting occurs when children are less than 2 years old. Stunting is a sign of long-term undernutrition and is associated with delayed cognitive development. Eggs provide protein, fatty acids, vitamin B12, choline and other nutrients that may support healthy growth and cognitive development. In a previous trial in Ecuador, infants who were provided eggs for daily consumption showed improved growth and lower rates of stunting than infants who were not provided eggs (2). Investigators are assessing whether children who consume eggs regularly over six months starting when they are 6 to 9 months old have higher height-for-age scores and lower rates of stunting than children who do not consume eggs regularly. Investigators are also assessing whether egg consumption improves Malawian infants' cognitive development. Because gut health is important for good nutrition, they are testing whether eggs have positive effects on measures of gut health and the gut microbiome. Finally, they are exploring the various metabolic pathways by which the nutrients available in eggs may influence infant growth and development. Participants are individually, randomly assigned to the egg intervention group or the control group. The mothers of infants who are randomly assigned to the egg intervention group receive 14 eggs each week and are asked to feed the infant one egg each day. Extra eggs are provided because sharing of food is common in Malawian households. The mothers of infants who are randomly assigned to the control group receive a package of foods at the end of the study that is equal in value to the eggs. Each mother/infant pair participates in the study for six months. When infants are enrolled, a baseline assessment is completed. This assessment includes a blood draw plus testing for anemia and malaria, anthropometric measurements, developmental assessments, 24-hour dietary recall interview, infant health history questionnaire. Mothers' heights and weights are also measured, and each mother is asked about socio-economic and demographic indicators and food security in her household. The anthropometric, dietary and development assessments are repeated after 3 months. At the end of the six month study period, anthropometric, dietary and development assessments are repeated, along with another blood draw. Additional data collected during the course of the study include: repeat 24-hour dietary recalls and monthly stool sample collection among a subsample of 200 children; twice-weekly observations of the index infant's egg consumption in the egg group or short questionnaire about the index infant's most recent meal in the control group; weekly morbidity history and animal source food consumption questionnaire among all infants; and focus groups and key informant interviews about production, availability and consumption of eggs among communities in the study area.

Official Title
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The Mazira Project: An Evaluation of Eggs During Complementary Feeding in Rural Malawi

Conditions
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Infant Malnutrition

Intervention / Treatment
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* Other: Eggs
* Behavioral: Visits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living in catchment area of Lungwena health center, Mangochi District, Malawi during the study enrollment period Singleton birth Exclusion Criteria: Egg allergy History of anaphylaxis or any serious allergic reaction requiring emergency medical care Congenital or chronic condition impacting growth and development or ability to eat eggs Severe anemia (hemoglobin < 5 g/dL) Mid-upper arm circumference < 12.5 cm or presence of bipedal edema Acute illness or injury warranting hospital referral

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 9 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egg Group<br>Egg Intervention: Provision of eggs to caregivers of enrolled infants, with instructions to prepare and feed one egg to the infant each day for 6 months time. Households will be visited twice weekly to provide eggs and monitor intake. | Other: Eggs<br>* Eggs provided as complementary food for the infant<br>Behavioral: Visits<br>* Twice weekly household visits by study staff<br>|
| Active Comparator: Control Group<br>Control Group: Caregivers will receive a food basket at the end of the study. Throughout the trial, households will be visited twice weekly and asked about food intake. | Behavioral: Visits<br>* Twice weekly household visits by study staff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length-for-age z-score | Child's recumbent length, standardized using the World Health Organization growth standards | 6 months after the start of the intervention | 
| Stunting | Prevalence of length-for-age z-score <-2 | 6 months after the start of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-for-age z-score and prevalence of underweight (WAZ<-2) |  | 6 months after the start of the intervention | 
| Weight-for-length z-score and prevalence of wasting (WLZ<-2) |  | 6 months after the start of the intervention | 
| Plasma choline concentration | Venous blood collection | 6 months after the start of the intervention | 
| Plasma amino acid concentrations | Venous blood collection | 6 months after the start of the intervention | 
| Cognitive development | Measured using the Malawi Development Assessment Tool (MDAT), Infant eye-tracking measures of declarative memory, and delayed imitation tasks | 6 months after the start of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complementary feeding, eggs, infant growth, stunting, cognitive development, choline, vitamin B12, microbiome