Effects of Infant Egg Consumption on Child Health and Cognition Development

NCT ID: NCT04345185

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5374 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-01-01
• Study Completion Date: 2019-11-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Project Viva

Project Viva (1999-present) enrolled 2,341 pregnancies and followed 2,128 children at delivery, 6 months, then yearly from 1 year to 15 years of child age.

Infant egg consumption (i.e., age of introduction and frequency of intake)

Intervention Type: OTHER

Infant Feeding Practices Study II

The Infant Feeding Practices Study II (IFPS II, 2005-2007) 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.

Infant egg consumption (i.e., age of introduction and frequency of intake)

Intervention Type: OTHER

Interventions

Infant egg consumption (i.e., age of introduction and frequency of intake)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Egg Board

OTHER

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Xiaozhong Wen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaozhong Wen

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00004022

Identifier Type: -

Identifier Source: org_study_id