Clinical trial NCT04785352: Grandi Byen: Test of an Integrated Parenting and Nutrition Intervention
Official title: Grandi Byen: Supporting Child Growth and Development Through Integrated, Responsive Parenting, Nutrition and Hygiene
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malnutrition, Child
Development, Child
Parenting
Keywords: Stunting
Responsive Parenting
Child Development
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Hôpital Universitaire Justinien
name: Université Publique du Nord au Cap-Haïtien
name: Konbit Sante
First posted: 2021-03-05
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Child Growth: Changes in length-for-age Z-score (LAZ)
timeFrame: Baseline and months 3, 6, 9, and 12
measure: Child Growth: Changes in weight-for-age Z-score (WAZ)
timeFrame: Baseline and months 3, 6, 9, and 12
measure: Child Growth: Changes in head circumference-for-age Z-score (HCZ)
timeFrame: Baseline and months 3, 6, 9, and 12
measure: Child Development: Changes in ASQ- Socio-Emotional (ASQ-SE) score
timeFrame: Baseline and months 6 and 12
measure: Child Development: Changes in ASQ Communication score
timeFrame: Baseline and months 6 and 12
measure: Child Development: Changes in ASQ Gross Motor score
timeFrame: Baseline and months 6 and 12
measure: Child Development: Changes in ASQ Fine Motor score
timeFrame: Baseline and months 6 and 12
measure: Child Development: Changes in ASQ Problem Solving score
timeFrame: Baseline and months 6 and 12
Secondary outcomes:
measure: Child Nutrient Biomarkers: Changes in Plasma Concentration of Docosahexaenoic acid (DHA)
timeFrame: Baseline and month 6
measure: Child Nutrient Biomarkers: Changes in Plasma Concentration of Choline
timeFrame: Baseline and month 6
measure: Child Nutrient Biomarkers: Changes in Plasma Concentration of Iron (Fe)
timeFrame: Baseline and month 6
measure: Child Nutrient Biomarkers: Changes in Plasma Concentration of Zinc (Zn)
timeFrame: Baseline and month 6
measure: Child Nutrient Biomarkers: Changes in Plasma Concentration of Iodine (I)
timeFrame: Baseline and month 6
measure: Child Nutrient Biomarkers: Changes in Plasma Concentration of Selenium (Se)
timeFrame: Baseline and month 6
measure: Child Bone Health: Changes in Bone Age Z-score
timeFrame: Baseline and months 3, 6, and 12
measure: Child Dietary Intake
timeFrame: Baseline and months 6 and 12
measure: Responsive Parenting: Changes in PICCOLO Affection Score
timeFrame: Baseline and months 6 and 12
measure: Responsive Parenting: Changes in PICCOLO Responsiveness Score
timeFrame: Baseline and months 6 and 12
measure: Responsive Parenting: Changes in PICCOLO Encouragement Score
timeFrame: Baseline and months 6 and 12
measure: Responsive Parenting: Changes in HOME Scores
timeFrame: Baseline and months 6 and 12
measure: Child Morbidities
timeFrame: Baseline and months 3, 6, 9, 12
Other outcomes:
Locations:
city: Cap-Haitien
country: Haiti
facility: Hôpital Universitaire Justinien
Study officials:
affiliation: Washington University School of Medicine
name: Lora L Iannotti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.