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Malnutrition, ChildNCT04785352

Grandi Byen: Test of an Integrated Parenting and Nutrition Intervention

A study testing Nutrition Intervention and Grandi Byen in people with Malnutrition, Child and Development, Child, run by Washington University School of Medicine at 1 site in Haiti.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 6 to 8 monthsHealthy volunteers can take part
Conditions the study is for
Malnutrition, Child, Development, Child, Parenting
What is being tested?
Nutrition Intervention and Grandi Byen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteHaiti
Study dates
1 Jul 2021to 1 Aug 2025
Phase
Interventional

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 6 to 8 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Haiti1 site
  • Hôpital Universitaire Justinien

    Cap-Haïtien

Other trials in Haiti

About this study

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

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.

Read the 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.

Being tested
Nutrition Intervention, Grandi Byen
Keywords
Stunting, Responsive Parenting, Child Development
Medical subject headings
Child Nutrition Disorders, Growth Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition InterventionDietary supplement

    One egg per day for six months

  • Grandi ByenBehavioural

    Multicomponent intervention on responsive parenting, nutrition, hygiene + one egg per day for 6 months

Study groups in NCT04785352
Study groupRoleWhat they receive
Standard well-baby careNo interventionChildren 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.
Nutrition InterventionExperimentalChildren in this arm will receive one egg per day for six months.
Receives: Dietary Supplement: Nutrition Intervention
Grandi ByenExperimentalThis arm comprises a multicomponent intervention on responsive parenting, nutrition, hygiene, and one egg per day for six months for children.
Receives: Behavioral: Grandi Byen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and months 3, 6, 9, and 12

  2. 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.

    Measured: Baseline and months 3, 6, 9, and 12

  3. 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.

    Measured: Baseline and months 3, 6, 9, and 12

  4. 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.

    Measured: Baseline and months 6 and 12

  5. Child Development: Changes in ASQ Communication score

    The Ages \& Stages Questionnaire (ASQ-3) will be used to assess and score children's communication skills.

    Measured: Baseline and months 6 and 12

  6. 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.

    Measured: Baseline and months 6 and 12

  7. 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.

    Measured: Baseline and months 6 and 12

  8. 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.

    Measured: Baseline and months 6 and 12

Secondary outcomes (13)
  1. Child Nutrient Biomarkers: Changes in Plasma Concentration of Docosahexaenoic acid (DHA)

    Plasma concentration of DHA measured in µg/mL

    Measured: Baseline and month 6

  2. Child Nutrient Biomarkers: Changes in Plasma Concentration of Choline

    Plasma concentration of Choline measured in µg/mL

    Measured: Baseline and month 6

  3. Child Nutrient Biomarkers: Changes in Plasma Concentration of Iron (Fe)

    Plasma concentration of Iron (Fe) measured in mg/mL

    Measured: Baseline and month 6

  4. Child Nutrient Biomarkers: Changes in Plasma Concentration of Zinc (Zn)

    Plasma concentration of Zinc (Zn) measured in mg/mL

    Measured: Baseline and month 6

  5. Child Nutrient Biomarkers: Changes in Plasma Concentration of Iodine (I)

    Plasma concentration of Iodine (I) measured in mg/mL

    Measured: Baseline and month 6

  6. Child Nutrient Biomarkers: Changes in Plasma Concentration of Selenium (Se)

    Plasma concentration of Selenium (Se) measured in µg/mL

    Measured: Baseline and month 6

  7. Child Bone Health: Changes in Bone Age Z-score

    Bone age z-scores are used as a measure of the child's bone health.

    Measured: Baseline and months 3, 6, and 12

  8. 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).

    Measured: Baseline and months 6 and 12

  9. 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.

    Measured: Baseline and months 6 and 12

  10. 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.

    Measured: Baseline and months 6 and 12

  11. 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.

    Measured: Baseline and months 6 and 12

  12. Responsive Parenting: Changes in HOME Scores

    The Home Observation Measurement of the Environment (HOME) inventory will be used in assessing the home environment.

    Measured: Baseline and months 6 and 12

  13. Child Morbidities

    Diarrhea, respiratory conditions, allergies.

    Measured: Baseline and months 3, 6, 9, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start1 Jul 2021
  3. Primary completion1 Aug 2025
  4. Study completion1 Aug 2025

Resources

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
Factorial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04785352
Sponsor's protocol ID
R01HD098255
Status last verified
Jun 2026
First submitted
24 Feb 2021
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Kohl PL, Gyimah EA, Diaz J, Kuhlmann FM, Dulience SJ, Embaye F, Brown DS, Guo S, Luby JL, Nicholas JL, Turner J, Chapnick M, Pierre JM, Boncy J, St Fleur R, Black MM, Iannotti LL. Grandi Byen-supporting child growth and development through integrated, responsive parenting, nutrition and hygiene: study protocol for a randomized controlled trial. BMC Pediatr. 2022 Jan 21;22(1):54. doi: 10.1186/s12887-021-03089-x.

    PubMed 35062907

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