Table 3 Grandi Byen study 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

 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