NCT04785352

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

4.1 years

First QC Date

February 24, 2021

Last Update Submit

October 8, 2024

Conditions

Malnutrition, ChildDevelopment, ChildParenting

Keywords

StuntingResponsive ParentingChild Development

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Baseline and months 6 and 12

Secondary Outcomes (13)

  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Docosahexaenoic acid (DHA)

    Baseline and month 6

  • Child Nutrient Biomarkers: Changes in Plasma Concentration of Choline

    Baseline and month 6

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

    Baseline and month 6

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

    Baseline and month 6

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

    Baseline and month 6

  • +8 more secondary outcomes

Study Arms (3)

Standard well-baby care

NO INTERVENTION

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.

Nutrition Intervention

EXPERIMENTAL

Children in this arm will receive one egg per day for six months.

Dietary Supplement: Nutrition Intervention

Grandi Byen

EXPERIMENTAL

This arm comprises a multicomponent intervention on responsive parenting, nutrition, hygiene, and one egg per day for six months for children.

Behavioral: Grandi Byen

Interventions

Nutrition InterventionDIETARY_SUPPLEMENT

One egg per day for six months

Nutrition Intervention
Grandi ByenBEHAVIORAL

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

Grandi Byen

Eligibility Criteria

Age6 Months - 8 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Universitaire Justinien

Cap-Haïtien, Haiti

Location

Related Publications (1)

  • 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.

    PMID: 35062907DERIVED

MeSH Terms

Conditions

Child Nutrition DisordersGrowth Disorders

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Lora L Iannotti, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Raters assessing responsive parenting and child development outcomes will be blind to the condition of mother-child dyads. For investigators, they will be blinded to participants' assigned study arms before and during handling and analysis of the data.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 5, 2021

Study Start

July 1, 2021

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Access Criteria
Researchers wanting to use the data would have to contact the PIs and explain their purpose for using the data.

Locations

HA(1)