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Table 3 Grandi Byen study outcomes

From: Grandi Byen—supporting child growth and development through integrated, responsive parenting, nutrition and hygiene: study protocol for a randomized controlled trial

Construct Methods Indicator Timepoints
Primary outcomes
 Child growth Anthropometric measures of height and weight Length-for-age Z score (LAZ)
Weight-for-age Z score (WAZ)
Weight-for-length Z score (WLZ)
Baseline, 3 mo, 6 mo, 9mo, 12 mo
 Cognitive, Language, Motor and Social Emotional Development Ages and Stages Questionnaires (ASQ)– Social-Emotional, Communication, Gross Motor, Fine Motor, and Problem-Solving Domains ASQ scores Baseline, 6 mo, 12 mo
Secondary outcomes
 Responsive parenting Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO);
Home Observation Measurement of the Environment (HOME), mother-infant observation
PICCOLO: Scores in Responsiveness, Affection, and Encouragement
HOME: environment subscale will be used to measure aspects of the household environment (i.e., availability of toys/items for child to play with) and responsive parenting.
Baseline, 6 mo, 12 mo
 Child dietary intake 24-hour recall and food frequency questionnaire Nutrient intakes, dietary diversity, and ASF consumption Baseline, 6 mo, 12 mo (24-hour recall)
Baseline, 3 mo, 6 mo, 9 mo, 12 mo (food frequency questionnaire)
 Child nutrient biomarkers Blood draw, mass spectrometry (LC-MS-MS, CP-OES) Plasma concentrations of nutrient biomarkers Baseline, 6 mo
 Child bone maturation Ultrasound imaging of hand and wrist Bone age Z score Baseline, 6 mo, 12 mo
 Child brain growth Ultrasound imaging of the head until anterior fontanelle closes Dimensions of brain regions (gangliothalamic ovoid, biparietal diameter, corpus callosum, other standard measures) Baseline, 6 mo
 Child morbidities Blood draw, immulite immunoassay methods
Stool samples
2-week morbidity recall by mothers
Plasma concentrations of inflammatory biomarkers (ovomucoid and ovalbumin IgE, C-reactive Protein [CRP], and Insulin-like growth factor 1 [IGF-1]).
Diarrhea, respiratory conditions, allergies
Baseline, 6 mo
 Child genetics Buccal swabs Targeted genomic analyses Baseline