An interventional study of Nutrition Intervention and Grandi Byen in Malnutrition, Child, Development, Child and Parenting, sponsored by Washington University School of Medicine. Completed at 1 site in Haiti. Open to participants aged 6 Months to 8 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
The premise of this trial is that a combined nutrition (eggs) and parenting behavior intervention (responsive parenting combined with the reinforcement of animal source foods and improved WASH) will synergistically result in improved child growth, development, and reduced enteric disease outcomes over and above a nutrition only intervention and standard well baby care.
This study is a 3-arm longitudinal randomized controlled trial (RCT) to compare the following groups for effectiveness in reducing young child stunted growth and enhancing overall development:1) standard well-baby care, (n=200); 2) nutrition intervention (one egg per day for 6 months), (n=200); and 3) multicomponent Grandi Byen intervention (responsive parenting, nutrition, hygiene + one egg per day for 6 months), (n=200).
Infants will be enrolled between 6-8 months of age and followed longitudinally for one year.
A disturbingly high number of young children around the world experience stunted growth and development with irreparable consequences through the lifespan. Determinants of stunted growth and development are multi-factorial, including interactions between biological, behavioral, social, and environmental conditions, yet the evidence-base is minimal for integrated approaches to tackle the interwoven factors. Our group recently found significant impacts from an egg intervention on young child growth and biomarkers of nutrition and brain development. The effects on important psychosocial indicators of child development, however, were not assessed. Building on these findings and those of our pilot study of a group-based, multicomponent intervention (Grandi Byen, Haitian Creole for "grow well"), this randomized controlled trial (RCT) seeks to examine a greater breadth of egg intervention outcomes, the synergistic effects of adding psychoeducational parenting to the egg intervention, and mediating biological, behavioral and social factors.
The 3-arm longitudinal RCT will be carried out in Cap-Haitien, Haiti, where our group has a decade of research experience, established partnerships, and a strong research infrastructure. It is representative of resource-poor urban contexts globally, where parents face common economic and environmental challenges to child growth and development. The trial will compare the following groups for effectiveness in reducing young child stunted growth and enhancing overall development: 1) standard well-baby care, (n=200); 2) nutrition intervention (one egg per day for 6 months), (n=200); and 3) multicomponent Grandi Byen intervention (responsive parenting, nutrition, hygiene + one egg per day for 6 months), (n=200). Infants will be enrolled between 6-8 months of age and followed longitudinally for one year.
The specific aims of this project are:
Aim 1 (primary): To demonstrate the reproducibility and feasibility of egg-based interventions in reducing childhood stunting, and test its impact on development. Hypothesis 1: Linear growth will be increased by 0.30 LAZ in children receiving one egg per day compared to standard care. Hypothesis 2: Children receiving the egg intervention will have better cognitive, motor and language development compared to standard care. Question 1 (exploratory): Does an egg-based intervention impact social-emotional development?
Aim 2 (primary): To investigate the incremental benefit of Grandi Byen compared to egg only and standard care groups on primary outcomes of child growth and development. Hypothesis 3: Children of mothers receiving Grandi Byen will increase linear growth by 0.10 LAZ compared to the egg intervention. Hypothesis 4: Children of mothers receiving Grandi Byen will have higher scores on child cognition, language, motor, and socio-emotional development, with an effect size of 0.36 on cognition, compared to standard care. An economic evaluation will be conducted to compare the efficiency of the interventions.
Aim 3 (secondary). To explore pathways of intervention impacts on child growth and development by delineating the additive and synergistic effects of biological (nutrient biomarkers, bone age, and enteric disease), psychosocial (responsive parenting, cognitive stimulation), and environmental (hygiene and sanitation, diet) factors.
This study expands upon this earlier work by bringing together a transdisciplinary team spanning the biological and social sciences to work in partnership with Haitian collaborators. We will merge methods and concepts to produce comprehensive perspectives on several high priority areas including social, economic and biological factors that impact child brain development and function, nutrition among infants and very young children, determinants of bone health; and traumatic stress associated with growing up in abject poverty.
167 studies on the registry are indexed under Child Nutrition Disorders; 36 are open to participants now.
This study's enrollment of 600 is above the median of 402 across 132 interventional studies indexed under Child Nutrition Disorders.
Browse Child Nutrition Disorders studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children in this arm (control group), as well as children in the two intervention groups, will receive standard care as outlined in the Essential Package of Health Services by Haiti's Ministry of Public Health and Population (MSPP). This includes a World Health Organization (WHO) immunization schedule of vaccines, high dose vitamin A supplements, and growth monitoring and promotion.
Children in this arm will receive one egg per day for six months.
Dietary Supplement: Nutrition Intervention
This arm comprises a multicomponent intervention on responsive parenting, nutrition, hygiene, and one egg per day for six months for children.
Behavioral: Grandi Byen
One egg per day for six months
Multicomponent intervention on responsive parenting, nutrition, hygiene + one egg per day for 6 months
Child Growth: Changes in length-for-age Z-score (LAZ)
Child length or height will be measured in centimeters (cm). Length-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months.
Time frame: Baseline and months 3, 6, 9, and 12
Child Growth: Changes in weight-for-age Z-score (WAZ)
Child weight will be measured in kilograms (kg). Weight-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months.
Time frame: Baseline and months 3, 6, 9, and 12
Child Growth: Changes in head circumference-for-age Z-score (HCZ)
Child head circumference will be measured in centimeters (cm). Head circumference-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months.
Time frame: Baseline and months 3, 6, 9, and 12
Child Development: Changes in ASQ- Socio-Emotional (ASQ-SE) score
The Ages \& Stages Questionnaire: Socio-Emotional Questionnaire (ASQ-SE2) will be used to assess and score child socio-emotional development.
Time frame: Baseline and months 6 and 12
Child Development: Changes in ASQ Communication score
The Ages \& Stages Questionnaire (ASQ-3) will be used to assess and score children's communication skills.
Time frame: Baseline and months 6 and 12
Child Development: Changes in ASQ Gross Motor score
The Ages \& Stages Questionnaire (ASQ-3) will be used to assess and score children's gross motor development.
Time frame: Baseline and months 6 and 12
Child Development: Changes in ASQ Fine Motor score
The Ages \& Stages Questionnaire (ASQ-3) will be used to assess and score children's fine motor development.
Time frame: Baseline and months 6 and 12
Child Development: Changes in ASQ Problem Solving score
The Ages \& Stages Questionnaire (ASQ-3) will be used to assess and score children's problem solving skills.
Time frame: Baseline and months 6 and 12
Child Nutrient Biomarkers: Changes in Plasma Concentration of Docosahexaenoic acid (DHA)
Plasma concentration of DHA measured in µg/mL
Time frame: Baseline and month 6
Child Nutrient Biomarkers: Changes in Plasma Concentration of Choline
Plasma concentration of Choline measured in µg/mL
Time frame: Baseline and month 6
Child Nutrient Biomarkers: Changes in Plasma Concentration of Iron (Fe)
Plasma concentration of Iron (Fe) measured in mg/mL
Time frame: Baseline and month 6
Child Nutrient Biomarkers: Changes in Plasma Concentration of Zinc (Zn)
Plasma concentration of Zinc (Zn) measured in mg/mL
Time frame: Baseline and month 6
Child Nutrient Biomarkers: Changes in Plasma Concentration of Iodine (I)
Plasma concentration of Iodine (I) measured in mg/mL
Time frame: Baseline and month 6
Child Nutrient Biomarkers: Changes in Plasma Concentration of Selenium (Se)
Plasma concentration of Selenium (Se) measured in µg/mL
Time frame: Baseline and month 6
Child Bone Health: Changes in Bone Age Z-score
Bone age z-scores are used as a measure of the child's bone health.
Time frame: Baseline and months 3, 6, and 12
Child Dietary Intake
24-hour recalls and food frequency recalls are used to assess nutrient intakes, dietary diversity, and consumption of Animal-Source Foods (ASFs).
Time frame: Baseline and months 6 and 12
Responsive Parenting: Changes in PICCOLO Affection Score
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) will be used to assess parent-child interactions, and a score for Affection will be calculated based on questionnaire items.
Time frame: Baseline and months 6 and 12
Responsive Parenting: Changes in PICCOLO Responsiveness Score
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) will be used to assess parent-child interactions, and a score for Responsiveness will be calculated based on questionnaire items.
Time frame: Baseline and months 6 and 12
Responsive Parenting: Changes in PICCOLO Encouragement Score
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) will be used to assess parent-child interactions, and a score for Encouragement will be calculated based on questionnaire items.
Time frame: Baseline and months 6 and 12
Responsive Parenting: Changes in HOME Scores
The Home Observation Measurement of the Environment (HOME) inventory will be used in assessing the home environment.
Time frame: Baseline and months 6 and 12
Child Morbidities
Diarrhea, respiratory conditions, allergies.
Time frame: Baseline and months 3, 6, 9, 12
Plan to share: Yes — Data collected for this study will be analyzed and stored on the on the REDCap platform and on Box, a secure, HIPAA and FERPA compliant data storage and online sharing platform. After the study is completed, the de-identified, archived data will be transmitted to and stored in a secure folder on Box; other researchers, including those outside of the study, who would want to use the deidentified data will only be able to access the data following approval from the PIs. Information pertaining to data sharing with other researchers is detailed during the informed consent process. During the conduct of the study, an individual participant can choose to withdraw consent to have biological specimens stored for future research. However, withdrawal of consent with regard to biosample storage may not be possible after the study is completed. When the study is completed, access to study data and/or samples will be provided through the approval of the PIs.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Access criteria: Researchers wanting to use the data would have to contact the PIs and explain their purpose for using the data.
Ran from Jul 2021 to primary completion in Aug 2025, 49 months.
Of 81 non-industry interventional studies with no phase under Child Nutrition Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's 49 months is above that.
Counting every sponsor, half of 84 studies reached it within 19 months; a quarter within 11 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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