Effects of Infant Egg Consumption on Child Health and Cognition Development

Completed

• Conditions: Metabolic Syndrome; Growth & Development; Cardiovascular Risk Factor; Food Allergy; Obesity; Cognitive Developmental Delay

• Registration Number: NCT04345185
• Lead Sponsor: State University of New York at Buffalo

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.

Study Timeline

• Study Start: 1999-01-01
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Study First Submitted: 2020-04-04
• Study First Submitted QC: 2020-04-11
• Study First Posted: 2020-04-14
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5374

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of food allergy	6 years	In the IFPS-II mothers reported the child's food allergy.
Fat mass	14-15 years	Research staff measured children's fat mass in Project Viva.
Lean mass	14-15 years	Research staff measured children's lean mass in Project Viva.
Trunk fat mass	14-15 years	Research staff measured children's trunk fat mass in Project Viva.
Systolic blood pressure	14-15 years (mid-teen)	Research staff measured children's systolic blood pressure in Project Viva.
Diastolic blood pressure	14-15 years (mid-teen)	Research staff measured children's diastolic blood pressure in Project Viva.
Weight	6 years	In IFPS II, mothers reported infant weight in survey.
Height	6 years	In IFPS II, mothers reported infant height in survey.
Waist Circumference	14-15 years	Research staff measured children's waist circumference in Project Viva.
Skinfold thickness	14-15 years	Research staff measured children's skinfold thickness in Project Viva.
Intelligence (PPVT-III test)	3 years	In Project Viva, trained research staff administered the Peabody Picture Vocabulary Test-3rd edition (PPVT-III, a test of receptive language) at 3 years of age.
Intelligence (KBIT-II test)	7 years	In Project Viva, trained research staff administered the Kaufman Brief Intelligence Test-2nd edition (KBIT-II, verbal and non-verbal intelligence) at 7 years of age.
Visual-motor (WRAVMA)	7 years	Research staff measured children's visual-motor in Project Viva. At the 7-years visit, staff administered the WRAVMA visual motor (drawing) subtest only.
Memory-learning	7 years	Research staff measured children's memory-learning in Project Viva. For the memory-learning domain, staff administered the design memory and picture memory subsets of Wide Range Assessment of Memory and Learning (WRAML) at the 7-years visit.

Trial Locations

Locations (1)

Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo; 🇺🇸 Buffalo, New York, United States