NCT04345185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,374

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
20.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

20.9 years

First QC Date

April 4, 2020

Last Update Submit

October 20, 2020

Conditions

Growth & DevelopmentObesityCardiovascular Risk FactorMetabolic SyndromeFood AllergyCognitive Developmental Delay

Outcome Measures

Primary Outcomes (73)

  • Weight

    Research staff measured children's weight in Project Viva.

    At 6 months (infancy)

  • Weight

    Research staff measured children's weight in Project Viva.

    3 years (early childhood)

  • Weight

    Research staff measured children's weight in Project Viva.

    7 years (mid-childhood)

  • Weight

    Research staff measured children's weight in Project Viva.

    12-13 years (early teen)

  • Weight

    Research staff measured children's weight in Project Viva.

    14-15 years (mid-teen)

  • Weight

    In IFPS II, mothers reported infant weight in survey.

    3 months

  • Weight

    In IFPS II, mothers reported infant weight survey.

    5 months

  • Weight

    In IFPS II, mothers reported infant weight in survey.

    7 months

  • Weight

    In IFPS II, mothers reported infant weight in survey.

    12 months

  • Weight

    In IFPS II, mothers reported infant weight in survey.

    6 years

  • Height

    Research staff measured children's height in Project Viva.

    6 months

  • Height

    Research staff measured children's height in Project Viva.

    3 years

  • Height

    Research staff measured children's height in Project Viva.

    7 years

  • Height

    Research staff measured children's height in Project Viva.

    12-13 years

  • Height

    Research staff measured children's height in Project Viva.

    14-15 years

  • Height

    In IFPS II, mothers reported infant height in survey.

    3 months

  • Height

    In IFPS II, mothers reported infant height in survey.

    5 months

  • Height

    In IFPS II, mothers reported infant height in survey.

    7 months

  • Height

    In IFPS II, mothers reported infant height in survey.

    12 months

  • Height

    In IFPS II, mothers reported infant height in survey.

    6 years

  • Waist Circumference

    Research staff measured children's waist circumference in Project Viva.

    6 months

  • Waist Circumference

    Research staff measured children's waist circumference in Project Viva.

    3 years

  • Waist Circumference

    Research staff measured children's waist circumference in Project Viva.

    7 years

  • Waist Circumference

    Research staff measured children's waist circumference in Project Viva.

    12-13 years

  • Waist Circumference

    Research staff measured children's waist circumference in Project Viva.

    14-15 years

  • Skinfold thickness

    Research staff measured children's skinfold thickness in Project Viva.

    3 years

  • Skinfold thickness

    Research staff measured children's skinfold thickness in Project Viva.

    7 years

  • Skinfold thickness

    Research staff measured children's skinfold thickness in Project Viva.

    12-13 years

  • Skinfold thickness

    Research staff measured children's skinfold thickness in Project Viva.

    14-15 years

  • Fat mass

    Research staff measured children's fat mass in Project Viva.

    7 years

  • Fat mass

    Research staff measured children's fat mass in Project Viva.

    12-13 years

  • Fat mass

    Research staff measured children's fat mass in Project Viva.

    14-15 years

  • Lean mass

    Research staff measured children's lean mass in Project Viva.

    7 years

  • Lean mass

    Research staff measured children's lean mass in Project Viva.

    12-13 years

  • Lean mass

    Research staff measured children's lean mass in Project Viva.

    14-15 years

  • Trunk fat mass

    Research staff measured children's trunk fat mass in Project Viva.

    7 years

  • Trunk fat mass

    Research staff measured children's trunk fat mass in Project Viva.

    12-13 years

  • Trunk fat mass

    Research staff measured children's trunk fat mass in Project Viva.

    14-15 years

  • Systolic blood pressure

    Research staff measured children's systolic blood pressure in Project Viva.

    7 years (mid-childhood)

  • Systolic blood pressure

    Research staff measured children's systolic blood pressure in Project Viva.

    12-13 years (early teen)

  • Systolic blood pressure

    Research staff measured children's systolic blood pressure in Project Viva.

    14-15 years (mid-teen)

  • Diastolic blood pressure

    Research staff measured children's diastolic blood pressure in Project Viva.

    7 years

  • Diastolic blood pressure

    Research staff measured children's diastolic blood pressure in Project Viva.

    12-13 years (early teen)

  • Diastolic blood pressure

    Research staff measured children's diastolic blood pressure in Project Viva.

    14-15 years (mid-teen)

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    2 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    3 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    4 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    5 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    6 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    7 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    8 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    9 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    10 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    11 years

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    12-13 years (early teen)

  • Diagnosis of food allergy

    Research staff measured children's food allergy in Project Viva.

    14-15 years (mid-teen)

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    2 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    3 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    4 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    5 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    6 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    7 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    8 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    9 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    10 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    11 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    12 months

  • Diagnosis of food allergy

    In the IFPS-II mothers reported the child's food allergy.

    6 years

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

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

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.

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

Interventions

Infant egg consumption (i.e., age of introduction and frequency of intake)OTHER
Infant Feeding Practices Study IIProject Viva

Eligibility Criteria

Age0 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 14214, United States

Location

MeSH Terms

Conditions

ObesityMetabolic SyndromeFood Hypersensitivity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Xiaozhong Wen

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 14, 2020

Study Start

January 1, 1999

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)