Clinical trial NCT04345185: Effects of Infant Egg Consumption on Child Health and Cognition Development
Official title: Effects of Infant Egg Consumption on Child Health and Cognition Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth & Development
Obesity
Cardiovascular Risk Factor
Metabolic Syndrome
Food Allergy
Cognitive Developmental Delay
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2020-04-14
Enrollment: 5374
Sex: ALL
Minimum age (years): 0
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will use existing data from two US longitudinal birth cohorts that tracked mother-child dyads from pregnancy to adolescence: 1) Project Viva (1999-present) that enrolled 2,341 pregnancies and followed 2,128 children at delivery, 6 months, then yearly from 1 year to 15 years of child age, and 2) the Infant Feeding Practices Study II (IFPS II, 2005-2007) that enrolled 3,033 pregnancies with surveys in late pregnancy, neonatal (1 month), then monthly from 2 months (N=2,552) to 12 months of infant age, and at 6 years.

Brief summary: The objective of this study is to examine how infant egg consumption (age of introduction and frequency of intake) influences physical growth, obesity, cardio-metabolic health, risk of food allergy, and cognition development in mid-childhood and adolescence.

Detailed description: The investigators will use existing data from two US longitudinal birth cohorts that tracked mother-child dyads from pregnancy to adolescence: 1) Project Viva (1999-present) that enrolled 2,341 pregnancies and followed 2,128 children at delivery, 6 months, then yearly from 1 year to 15 years of child age, and 2) the Infant Feeding Practices Study II (IFPS II, 2005-2007) that enrolled 3,033 pregnancies with surveys in late pregnancy, neonatal (1 month), then monthly from 2 months (N=2,552) to 12 months of infant age, and at 6 years. For Aim 1, the investigators will classify infants based on their age of egg introduction: never, \<2 months, 2-3 months, 4-5 months, 6-8 months, 9-11 months, and 12 months. The investigators will compare physical growth, obesity, cardio-metabolic health, food allergy, and cognition test scores in mid-childhood and adolescence. The investigators will fit multi-variable linear or logistic regression models with fractional polynomial functions of the infant age of egg introduction. Both linear (e.g., earlier introduction, a higher probability of the outcome) and non-linear (e.g., threshold effect) associations will be tested. For Aim 2, The investigators will classify infants based on their frequency of egg intake: never, \<once/week, once/week, 2-4 times/week, nearly daily or daily, and 2 times/day. The investigators will use similar analytic methods mentioned above to compare their later outcomes. Finally, the investigators will create an average probability of multiple child outcomes to balance across different aspects of child health and development. The investigators will identify the lowest-risk infant egg consumption when the corresponding average predicted probability of the related adverse outcomes is the lowest.

Eligibility criteria: Inclusion Criteria:

* Children with complete data on infant egg consumption and the corresponding health and cognition outcomes.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Weight
timeFrame: At 6 months (infancy)
measure: Weight
timeFrame: 3 years (early childhood)
measure: Weight
timeFrame: 7 years (mid-childhood)
measure: Weight
timeFrame: 12-13 years (early teen)
measure: Weight
timeFrame: 14-15 years (mid-teen)
measure: Weight
timeFrame: 3 months
measure: Weight
timeFrame: 5 months
measure: Weight
timeFrame: 7 months
measure: Weight
timeFrame: 12 months
measure: Weight
timeFrame: 6 years
measure: Height
timeFrame: 6 months
measure: Height
timeFrame: 3 years
measure: Height
timeFrame: 7 years
measure: Height
timeFrame: 12-13 years
measure: Height
timeFrame: 14-15 years
measure: Height
timeFrame: 3 months
measure: Height
timeFrame: 5 months
measure: Height
timeFrame: 7 months
measure: Height
timeFrame: 12 months
measure: Height
timeFrame: 6 years
measure: Waist Circumference
timeFrame: 6 months
measure: Waist Circumference
timeFrame: 3 years
measure: Waist Circumference
timeFrame: 7 years
measure: Waist Circumference
timeFrame: 12-13 years
measure: Waist Circumference
timeFrame: 14-15 years
measure: Skinfold thickness
timeFrame: 3 years
measure: Skinfold thickness
timeFrame: 7 years
measure: Skinfold thickness
timeFrame: 12-13 years
measure: Skinfold thickness
timeFrame: 14-15 years
measure: Fat mass
timeFrame: 7 years
measure: Fat mass
timeFrame: 12-13 years
measure: Fat mass
timeFrame: 14-15 years
measure: Lean mass
timeFrame: 7 years
measure: Lean mass
timeFrame: 12-13 years
measure: Lean mass
timeFrame: 14-15 years
measure: Trunk fat mass
timeFrame: 7 years
measure: Trunk fat mass
timeFrame: 12-13 years
measure: Trunk fat mass
timeFrame: 14-15 years
measure: Systolic blood pressure
timeFrame: 7 years (mid-childhood)
measure: Systolic blood pressure
timeFrame: 12-13 years (early teen)
measure: Systolic blood pressure
timeFrame: 14-15 years (mid-teen)
measure: Diastolic blood pressure
timeFrame: 7 years
measure: Diastolic blood pressure
timeFrame: 12-13 years (early teen)
measure: Diastolic blood pressure
timeFrame: 14-15 years (mid-teen)
measure: Diagnosis of food allergy
timeFrame: 2 years
measure: Diagnosis of food allergy
timeFrame: 3 years
measure: Diagnosis of food allergy
timeFrame: 4 years
measure: Diagnosis of food allergy
timeFrame: 5 years
measure: Diagnosis of food allergy
timeFrame: 6 years
measure: Diagnosis of food allergy
timeFrame: 7 years
measure: Diagnosis of food allergy
timeFrame: 8 years
measure: Diagnosis of food allergy
timeFrame: 9 years
measure: Diagnosis of food allergy
timeFrame: 10 years
measure: Diagnosis of food allergy
timeFrame: 11 years
measure: Diagnosis of food allergy
timeFrame: 12-13 years (early teen)
measure: Diagnosis of food allergy
timeFrame: 14-15 years (mid-teen)
measure: Diagnosis of food allergy
timeFrame: 2 months
measure: Diagnosis of food allergy
timeFrame: 3 months
measure: Diagnosis of food allergy
timeFrame: 4 months
measure: Diagnosis of food allergy
timeFrame: 5 months
measure: Diagnosis of food allergy
timeFrame: 6 months
measure: Diagnosis of food allergy
timeFrame: 7 months
measure: Diagnosis of food allergy
timeFrame: 8 months
measure: Diagnosis of food allergy
timeFrame: 9 months
measure: Diagnosis of food allergy
timeFrame: 10 months
measure: Diagnosis of food allergy
timeFrame: 11 months
measure: Diagnosis of food allergy
timeFrame: 12 months
measure: Diagnosis of food allergy
timeFrame: 6 years
measure: Intelligence (PPVT-III test)
timeFrame: 3 years
measure: Intelligence (KBIT-II test)
timeFrame: 7 years
measure: Visual-motor (WRAVMA)
timeFrame: 3 years
measure: Visual-motor (WRAVMA)
timeFrame: 7 years
measure: Memory-learning
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Xiaozhong Wen
role: PRINCIPAL_INVESTIGATOR
References: