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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04345185
Other study ID # STUDY00004022
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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