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

Primary Purpose

Malnutrition, Child, Development, Child, Parenting

Status
Recruiting
Phase
Not Applicable
Locations
Haiti
Study Type
Interventional
Intervention
Nutrition Intervention
Grandi Byen
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition, Child focused on measuring Stunting, Responsive Parenting, Child Development

Eligibility Criteria

6 Months - 8 Months (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Hôpital Universitaire JustinienRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard well-baby care

Nutrition Intervention

Grandi Byen

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Child Development: Changes in ASQ Communication score
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
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
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
The Ages & Stages Questionnaire (ASQ-3) will be used to assess and score children's problem solving skills.

Secondary Outcome Measures

Child Nutrient Biomarkers: Changes in Plasma Concentration of Docosahexaenoic acid (DHA)
Plasma concentration of DHA measured in µg/mL
Child Nutrient Biomarkers: Changes in Plasma Concentration of Choline
Plasma concentration of Choline measured in µg/mL
Child Nutrient Biomarkers: Changes in Plasma Concentration of Iron (Fe)
Plasma concentration of Iron (Fe) measured in mg/mL
Child Nutrient Biomarkers: Changes in Plasma Concentration of Zinc (Zn)
Plasma concentration of Zinc (Zn) measured in mg/mL
Child Nutrient Biomarkers: Changes in Plasma Concentration of Iodine (I)
Plasma concentration of Iodine (I) measured in mg/mL
Child Nutrient Biomarkers: Changes in Plasma Concentration of Selenium (Se)
Plasma concentration of Selenium (Se) measured in µg/mL
Child Bone Health: Changes in Bone Age Z-score
Bone age z-scores are used as a measure of the child's bone health.
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).
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.
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.
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.
Responsive Parenting: Changes in HOME Scores
The Home Observation Measurement of the Environment (HOME) inventory will be used in assessing the home environment.
Child Morbidities
Diarrhea, respiratory conditions, allergies.

Full Information

First Posted
February 24, 2021
Last Updated
September 28, 2023
Sponsor
Washington University School of Medicine
Collaborators
Hôpital Universitaire Justinien, Université Publique du Nord au Cap-Haïtien, Konbit Sante
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1. Study Identification

Unique Protocol Identification Number
NCT04785352
Brief Title
Grandi Byen: Supporting Child Growth and Development Through Integrated, Responsive Parenting, Nutrition and Hygiene
Official Title
Grandi Byen: Supporting Child Growth and Development Through Integrated, Responsive Parenting, Nutrition and Hygiene
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Hôpital Universitaire Justinien, Université Publique du Nord au Cap-Haïtien, Konbit Sante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child, Development, Child, Parenting
Keywords
Stunting, Responsive Parenting, Child Development

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard well-baby care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Nutrition Intervention
Arm Type
Experimental
Arm Description
Children in this arm will receive one egg per day for six months.
Arm Title
Grandi Byen
Arm Type
Experimental
Arm Description
This arm comprises a multicomponent intervention on responsive parenting, nutrition, hygiene, and one egg per day for six months for children.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition Intervention
Intervention Description
One egg per day for six months
Intervention Type
Behavioral
Intervention Name(s)
Grandi Byen
Intervention Description
Multicomponent intervention on responsive parenting, nutrition, hygiene + one egg per day for 6 months
Primary Outcome Measure Information:
Title
Child Growth: Changes in length-for-age Z-score (LAZ)
Description
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
Title
Child Growth: Changes in weight-for-age Z-score (WAZ)
Description
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
Title
Child Growth: Changes in head circumference-for-age Z-score (HCZ)
Description
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
Title
Child Development: Changes in ASQ- Socio-Emotional (ASQ-SE) score
Description
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
Title
Child Development: Changes in ASQ Communication score
Description
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
Title
Child Development: Changes in ASQ Gross Motor score
Description
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
Title
Child Development: Changes in ASQ Fine Motor score
Description
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
Title
Child Development: Changes in ASQ Problem Solving score
Description
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
Secondary Outcome Measure Information:
Title
Child Nutrient Biomarkers: Changes in Plasma Concentration of Docosahexaenoic acid (DHA)
Description
Plasma concentration of DHA measured in µg/mL
Time Frame
Baseline and month 6
Title
Child Nutrient Biomarkers: Changes in Plasma Concentration of Choline
Description
Plasma concentration of Choline measured in µg/mL
Time Frame
Baseline and month 6
Title
Child Nutrient Biomarkers: Changes in Plasma Concentration of Iron (Fe)
Description
Plasma concentration of Iron (Fe) measured in mg/mL
Time Frame
Baseline and month 6
Title
Child Nutrient Biomarkers: Changes in Plasma Concentration of Zinc (Zn)
Description
Plasma concentration of Zinc (Zn) measured in mg/mL
Time Frame
Baseline and month 6
Title
Child Nutrient Biomarkers: Changes in Plasma Concentration of Iodine (I)
Description
Plasma concentration of Iodine (I) measured in mg/mL
Time Frame
Baseline and month 6
Title
Child Nutrient Biomarkers: Changes in Plasma Concentration of Selenium (Se)
Description
Plasma concentration of Selenium (Se) measured in µg/mL
Time Frame
Baseline and month 6
Title
Child Bone Health: Changes in Bone Age Z-score
Description
Bone age z-scores are used as a measure of the child's bone health.
Time Frame
Baseline and months 3, 6, and 12
Title
Child Dietary Intake
Description
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
Title
Responsive Parenting: Changes in PICCOLO Affection Score
Description
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
Title
Responsive Parenting: Changes in PICCOLO Responsiveness Score
Description
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
Title
Responsive Parenting: Changes in PICCOLO Encouragement Score
Description
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
Title
Responsive Parenting: Changes in HOME Scores
Description
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
Title
Child Morbidities
Description
Diarrhea, respiratory conditions, allergies.
Time Frame
Baseline and months 3, 6, 9, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia L Kohl, PhD
Phone
314-935-7438
Email
pkohl@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lora L Iannotti, PhD
Phone
314-935-4396
Email
liannotti@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lora L Iannotti, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Universitaire Justinien
City
Cap-Haitien
Country
Haiti
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rony Saint Fleur, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Access Criteria
Researchers wanting to use the data would have to contact the PIs and explain their purpose for using the data.
Citations:
PubMed Identifier
35062907
Citation
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.
Results Reference
derived

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

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