Hôpital Universitaire Justinien
Cap-Haïtien, Haiti
NCT Number: NCT04785352
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.
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Notify Me6 month–8 month
All sexes
Interventional
Not applicable
Cap-Haïtien, Haiti
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One egg per day for six months
Multicomponent intervention on responsive parenting, nutrition, hygiene + one egg per day for 6 months
Time frame: Baseline and months 3, 6, 9, and 12
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 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 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 6 and 12
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
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
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
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
The Ages & Stages Questionnaire (ASQ-3) will be used to assess and score children's problem solving skills.
Time frame: Baseline and month 6
Plasma concentration of DHA measured in µg/mL
Time frame: Baseline and month 6
Plasma concentration of Choline measured in µg/mL
Time frame: Baseline and month 6
Plasma concentration of Iron (Fe) measured in mg/mL
Time frame: Baseline and month 6
Plasma concentration of Zinc (Zn) measured in mg/mL
Time frame: Baseline and month 6
Plasma concentration of Iodine (I) measured in mg/mL
Time frame: Baseline and month 6
Plasma concentration of Selenium (Se) measured in µg/mL
Time frame: Baseline and months 3, 6, and 12
Bone age z-scores are used as a measure of the child's bone health.
Time frame: Baseline and months 6 and 12
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
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
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
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
The Home Observation Measurement of the Environment (HOME) inventory will be used in assessing the home environment.
Time frame: Baseline and months 3, 6, 9, 12
Diarrhea, respiratory conditions, allergies.
Washington University School of Medicine
Other
Grandi Byen: Supporting Child Growth and Development Through Integrated, Responsive Parenting, Nutrition and Hygiene
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