Effects of Infant Egg Consumption on Child Health and Cognition Development

Obesity Clinical Trial

Official title:

Effects of Infant Egg Consumption on Child Health and Cognition Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04345185
• Other study ID #: STUDY00004022
• Status: Completed
• Start date: January 1, 1999
• Est. completion date: November 30, 2019

Study information

• Verified date: October 2020
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5374
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	American Egg Board

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Research staff measured children's weight in Project Viva.	At 6 months (infancy)
Primary	Weight	Research staff measured children's weight in Project Viva.	3 years (early childhood)
Primary	Weight	Research staff measured children's weight in Project Viva.	7 years (mid-childhood)
Primary	Weight	Research staff measured children's weight in Project Viva.	12-13 years (early teen)
Primary	Weight	Research staff measured children's weight in Project Viva.	14-15 years (mid-teen)
Primary	Weight	In IFPS II, mothers reported infant weight in survey.	3 months
Primary	Weight	In IFPS II, mothers reported infant weight survey.	5 months
Primary	Weight	In IFPS II, mothers reported infant weight in survey.	7 months
Primary	Weight	In IFPS II, mothers reported infant weight in survey.	12 months
Primary	Weight	In IFPS II, mothers reported infant weight in survey.	6 years
Primary	Height	Research staff measured children's height in Project Viva.	6 months
Primary	Height	Research staff measured children's height in Project Viva.	3 years
Primary	Height	Research staff measured children's height in Project Viva.	7 years
Primary	Height	Research staff measured children's height in Project Viva.	12-13 years
Primary	Height	Research staff measured children's height in Project Viva.	14-15 years
Primary	Height	In IFPS II, mothers reported infant height in survey.	3 months
Primary	Height	In IFPS II, mothers reported infant height in survey.	5 months
Primary	Height	In IFPS II, mothers reported infant height in survey.	7 months
Primary	Height	In IFPS II, mothers reported infant height in survey.	12 months
Primary	Height	In IFPS II, mothers reported infant height in survey.	6 years
Primary	Waist Circumference	Research staff measured children's waist circumference in Project Viva.	6 months
Primary	Waist Circumference	Research staff measured children's waist circumference in Project Viva.	3 years
Primary	Waist Circumference	Research staff measured children's waist circumference in Project Viva.	7 years
Primary	Waist Circumference	Research staff measured children's waist circumference in Project Viva.	12-13 years
Primary	Waist Circumference	Research staff measured children's waist circumference in Project Viva.	14-15 years
Primary	Skinfold thickness	Research staff measured children's skinfold thickness in Project Viva.	3 years
Primary	Skinfold thickness	Research staff measured children's skinfold thickness in Project Viva.	7 years
Primary	Skinfold thickness	Research staff measured children's skinfold thickness in Project Viva.	12-13 years
Primary	Skinfold thickness	Research staff measured children's skinfold thickness in Project Viva.	14-15 years
Primary	Fat mass	Research staff measured children's fat mass in Project Viva.	7 years
Primary	Fat mass	Research staff measured children's fat mass in Project Viva.	12-13 years
Primary	Fat mass	Research staff measured children's fat mass in Project Viva.	14-15 years
Primary	Lean mass	Research staff measured children's lean mass in Project Viva.	7 years
Primary	Lean mass	Research staff measured children's lean mass in Project Viva.	12-13 years
Primary	Lean mass	Research staff measured children's lean mass in Project Viva.	14-15 years
Primary	Trunk fat mass	Research staff measured children's trunk fat mass in Project Viva.	7 years
Primary	Trunk fat mass	Research staff measured children's trunk fat mass in Project Viva.	12-13 years
Primary	Trunk fat mass	Research staff measured children's trunk fat mass in Project Viva.	14-15 years
Primary	Systolic blood pressure	Research staff measured children's systolic blood pressure in Project Viva.	7 years (mid-childhood)
Primary	Systolic blood pressure	Research staff measured children's systolic blood pressure in Project Viva.	12-13 years (early teen)
Primary	Systolic blood pressure	Research staff measured children's systolic blood pressure in Project Viva.	14-15 years (mid-teen)
Primary	Diastolic blood pressure	Research staff measured children's diastolic blood pressure in Project Viva.	7 years
Primary	Diastolic blood pressure	Research staff measured children's diastolic blood pressure in Project Viva.	12-13 years (early teen)
Primary	Diastolic blood pressure	Research staff measured children's diastolic blood pressure in Project Viva.	14-15 years (mid-teen)
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	2 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	3 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	4 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	5 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	6 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	7 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	8 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	9 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	10 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	11 years
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	12-13 years (early teen)
Primary	Diagnosis of food allergy	Research staff measured children's food allergy in Project Viva.	14-15 years (mid-teen)
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	2 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	3 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	4 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	5 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	6 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	7 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	8 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	9 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	10 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	11 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	12 months
Primary	Diagnosis of food allergy	In the IFPS-II mothers reported the child's food allergy.	6 years
Primary	Intelligence (PPVT-III test)	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.	3 years
Primary	Intelligence (KBIT-II test)	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.	7 years
Primary	Visual-motor (WRAVMA)	Research staff measured children's visual-motor in Project Viva. For the visual-motor domain, research staff administered the Wide Range Assessment of Visual Motor Abilities (WRAVMA) at the 3-years visit.	3 years
Primary	Visual-motor (WRAVMA)	Research staff measured children's visual-motor in Project Viva. At the 7-years visit, staff administered the WRAVMA visual motor (drawing) subtest only.	7 years
Primary	Memory-learning	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.	7 years