Grandi Byen: Supporting Child Growth and Development Through Integrated, Responsive Parenting, Nutrition and Hygiene

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2025

Detailed Description

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.

Interventions

  • Dietary Supplement: Nutrition Intervention
    • One egg per day for six months
  • Behavioral: Grandi Byen
    • Multicomponent intervention on responsive parenting, nutrition, hygiene + one egg per day for 6 months

Arms, Groups and Cohorts

  • No Intervention: Standard well-baby care
    • 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.
  • Experimental: Nutrition Intervention
    • Children in this arm will receive one egg per day for six months.
  • Experimental: Grandi Byen
    • This arm comprises a multicomponent intervention on responsive parenting, nutrition, hygiene, and one egg per day for six months for children.

Clinical Trial Outcome Measures

Primary Measures

  • Child Growth: Changes in length-for-age Z-score (LAZ)
    • 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.
  • Child Growth: Changes in weight-for-age Z-score (WAZ)
    • 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.
  • Child Growth: Changes in head circumference-for-age Z-score (HCZ)
    • 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.
  • Child Development: Changes in ASQ- Socio-Emotional (ASQ-SE) score
    • 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.
  • Child Development: Changes in ASQ Communication score
    • 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.
  • Child Development: Changes in ASQ Gross Motor score
    • 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.
  • Child Development: Changes in ASQ Fine Motor score
    • 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.
  • Child Development: Changes in ASQ Problem Solving score
    • 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.

Secondary Measures

  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Docosahexaenoic acid (DHA)
    • Time Frame: Baseline and month 6
    • Plasma concentration of DHA measured in µg/mL
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Choline
    • Time Frame: Baseline and month 6
    • Plasma concentration of Choline measured in µg/mL
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Iron (Fe)
    • Time Frame: Baseline and month 6
    • Plasma concentration of Iron (Fe) measured in mg/mL
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Zinc (Zn)
    • Time Frame: Baseline and month 6
    • Plasma concentration of Zinc (Zn) measured in mg/mL
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Iodine (I)
    • Time Frame: Baseline and month 6
    • Plasma concentration of Iodine (I) measured in mg/mL
  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Selenium (Se)
    • Time Frame: Baseline and month 6
    • Plasma concentration of Selenium (Se) measured in µg/mL
  • Child Bone Health: Changes in Bone Age Z-score
    • Time Frame: Baseline and months 3, 6, and 12
    • Bone age z-scores are used as a measure of the child’s bone health.
  • Child Dietary Intake
    • 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).
  • Responsive Parenting: Changes in PICCOLO Affection Score
    • 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.
  • Responsive Parenting: Changes in PICCOLO Responsiveness Score
    • 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.
  • Responsive Parenting: Changes in PICCOLO Encouragement Score
    • 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.
  • Responsive Parenting: Changes in HOME Scores
    • 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.
  • Child Morbidities
    • Time Frame: Baseline and months 3, 6, 9, 12
    • Diarrhea, respiratory conditions, allergies.

Participating in This Clinical Trial

Inclusion Criteria

  • Mothers/Caregivers 18 years or older of infants ages 6-8 months – Infants ages 6-8 months – Living in Petite Anse, Fort Saint Michel, Madeline, or similiar communities (Cap-Haitien, Haiti) Exclusion Criteria:

  • Multi-birth infant (twin, triplet, etc.) – congenital health condition – severe disabilities – severely malnourished (WLZ<-3) – child has an allergy to animal-source foods (specifically eggs, milk, or fish).

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 8 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • Hôpital Universitaire Justinien
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lora L Iannotti, PhD, Principal Investigator, Washington University School of Medicine
  • Overall Contact(s)
    • Patricia L Kohl, PhD, 314-935-7438, pkohl@wustl.edu

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