2.5.2. A Priori Defined Endpoints for Descriptive Statistics
depression, Depression, fat-free mass
Physical growth (safety assessment) was assessed at each visit. Safety endpoints for the clinical trial were weight (kg), length (cm), head circumference (cm), and corresponding percentiles. The infant body composition was assessed via air displacement plethysmography (PeaPod—COSMED S.R.L. Viale Bruno Buozzi 77, 00197 Rome (Italy)) and described by the total weight, fat, and fat-free mass measured at baseline, 6 weeks, 3 and 6 months, and at 9 months only if the baby’s weight was less than or equal to 17 lb or 7.71 kg and the height was less than or equal to 24.8 inches, or 63.5 cm.Child activity level was assessed using an activity tracker (FitBit ZipMaternal postnatal depression was assessed at screening for mothers, if this visit occurred prior to delivery, at 6 weeks and at 3 months postpartum using the Edinburgh Postnatal Depression Scale (EPDS) [Parenting stress was assessed at 6 weeks and 6, 18, and 24 months of infant age using the Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF). The PSI is a self-report questionnaire to identify potentially dysfunctional parent–child dyads. It consists of 36 items that are combined into 3 scales: parental distress, difficult child characteristics, and dysfunctional parent–child interaction. The questionnaire can be used with parents of children from 1 month to 12 years of age. Outcome measures for the clinical trial were the total score and scores of the 3 subscales.The maternal IQ estimate was assessed at maternal screening visit 1 (SV1) using the Wechsler Abbreviated Scale of Intelligence, second edition (WASI-II). The four-subtest form of the standardized cognitive ability test consists of the four subscales: vocabulary, similarities, block design, and matrix reasoning. The test is administered by qualified staff and is applicable for children and adults 6 to 89 years of age. The test has demonstrated reliability and validity. Outcome measures for the clinical trial were the full-scale IQ.Nutritional intake was assessed at 6, 9, 12, 18, and 24 months. Parents were asked to record their baby’s food intake and dietary supplement use for 3 days on a food record collection booklet before defined visits. The booklet was distributed at the previous visit and included food record forms for reporting food intake and dietary supplement use for 3 days, along with instructions for completing the forms. The food records were sent to the University of Minnesota Nutrition Coordinating Center for entry into the Nutrition Data System for Research (NDSR) nutrient and food group intakes. Outcome measures for dietary intake components of the clinical trial were intake of nutrients (macro- and micro-nutrients), nutrient ratios, and food group consumption by age.