Abstract

BackgroundPoor child growth and development outcomes stem from complex relationships encompassing biological, behavioral, social, and environmental conditions. However, there is a dearth of research on integrated approaches targeting these interwoven factors. The Grandi Byen study seeks to fill this research gap through a three-arm longitudinal randomized controlled trial which will evaluate the impact of an integrated nutrition, responsive parenting, and WASH (water, sanitation and hygiene) intervention on holistic child growth and development.MethodsWe will recruit 600 mother-infant dyads living in Cap-Haitien, Haiti and randomize them equally into one of the following groups: 1) standard well-baby care; 2) nutritional intervention (one egg per day for 6 months); and 3) multicomponent Grandi Byen intervention (responsive parenting, nutrition, WASH + one egg per day for 6 months). Primary outcomes include child growth as well as cognitive, language, motor, and social-emotional development. The study also assesses other indicators of child health (bone maturation, brain growth, diarrheal morbidity and allergies, dietary intake, nutrient biomarkers) along with responsive parenting as mediating factors influencing the primary outcomes. An economic evaluation will assess the feasibility of large-scale implementation of the interventions.DiscussionThis study builds on research highlighting the importance of responsive parenting interventions on overall child health, as well as evidence demonstrating that providing an egg daily to infants during the complementary feeding period can prevent stunted growth. The multicomponent Grandi Byen intervention may provide evidence of synergistic or mediating effects of an egg intervention with instruction on psychoeducational parenting and WASH on child growth and development. Grandi Byen presents key innovations with implications for the well-being of children living in poverty globally.Trial registrationNCT04785352. Registered March 5, 2021 at https://clinicaltrials.gov/

Highlights

  • Poor child growth and development outcomes stem from complex relationships encompassing biological, behavioral, social, and environmental conditions

  • For the 6-month followup of children who were ages 6-9 months at baseline, the results showed that children in the egg group had an increased length-for-age Z-score (LAZ) and 47% lower prevalence of stunting compared to the control group [10]

  • Using the repeated measures module of the software under the setting of a cluster randomized trial with person-level outcomes and assuming an intraclass correlation coefficient (ICC) of 0.7, we found that the study will have a statistical power of 0.80 to detect an effect size of 0.338, which is slightly above the small effect size defined by Cohen’s d

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Summary

Methods

Primary outcomes Child growth Cognitive, Language, Motor and Social Emotional Develop‐ ment Secondary outcomes Responsive parenting. The different timepoints (i.e., five waves of data collection at baseline and 3-, 6-, 9-, and 12-month follow-ups) are nested within children. Aim 3 examines the pathways to child growth and development by testing a series of mediational effects of secondary outcomes: responsive parenting, child dietary diversity and nutrient intakes, biomarker status, allergies, bone maturation, acute diarrhea, and respiratory morbidity. Benefit-cost ratios reflect efficiency (B2/C2, B3/C3), while net differences indicate how much, if any, an arm improves net welfare [(B2-B1)-(C2-C1)] and [(B3-B2)-(C3-C2)] For both types of economic evaluation, we will conduct sensitivity analysis of the estimates using both simple 1-way (min/max) and Monte Carlo (multi-way, probabilistic) approaches to reflect statistical confidence intervals in study impacts and costs. In the CEA, costs and effects are measured in a single year, but in the CBA, benefits include a “stream” of gains (estimated into the future) and must be discounted following standard guidelines of 3-12% [96, 97, 99], a factor included the sensitivity analysis

Discussion
Background
Methods/Design
10 Engaging with your children
Findings
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