Effects of Infant Egg Consumption on Child Health and Cognition Development

October 20, 2020 updated by: Xiaozhong Wen, State University of New York at Buffalo
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5374

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14214
        • Division of Behavioral Medicine Department of Pediatrics Jacobs School of Medicine and Biomedical Sciences State University of New York at Buffalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: At 6 months (infancy)
Research staff measured children's weight in Project Viva.
At 6 months (infancy)
Weight
Time Frame: 3 years (early childhood)
Research staff measured children's weight in Project Viva.
3 years (early childhood)
Weight
Time Frame: 7 years (mid-childhood)
Research staff measured children's weight in Project Viva.
7 years (mid-childhood)
Weight
Time Frame: 12-13 years (early teen)
Research staff measured children's weight in Project Viva.
12-13 years (early teen)
Weight
Time Frame: 14-15 years (mid-teen)
Research staff measured children's weight in Project Viva.
14-15 years (mid-teen)
Weight
Time Frame: 3 months
In IFPS II, mothers reported infant weight in survey.
3 months
Weight
Time Frame: 5 months
In IFPS II, mothers reported infant weight survey.
5 months
Weight
Time Frame: 7 months
In IFPS II, mothers reported infant weight in survey.
7 months
Weight
Time Frame: 12 months
In IFPS II, mothers reported infant weight in survey.
12 months
Weight
Time Frame: 6 years
In IFPS II, mothers reported infant weight in survey.
6 years
Height
Time Frame: 6 months
Research staff measured children's height in Project Viva.
6 months
Height
Time Frame: 3 years
Research staff measured children's height in Project Viva.
3 years
Height
Time Frame: 7 years
Research staff measured children's height in Project Viva.
7 years
Height
Time Frame: 12-13 years
Research staff measured children's height in Project Viva.
12-13 years
Height
Time Frame: 14-15 years
Research staff measured children's height in Project Viva.
14-15 years
Height
Time Frame: 3 months
In IFPS II, mothers reported infant height in survey.
3 months
Height
Time Frame: 5 months
In IFPS II, mothers reported infant height in survey.
5 months
Height
Time Frame: 7 months
In IFPS II, mothers reported infant height in survey.
7 months
Height
Time Frame: 12 months
In IFPS II, mothers reported infant height in survey.
12 months
Height
Time Frame: 6 years
In IFPS II, mothers reported infant height in survey.
6 years
Waist Circumference
Time Frame: 6 months
Research staff measured children's waist circumference in Project Viva.
6 months
Waist Circumference
Time Frame: 3 years
Research staff measured children's waist circumference in Project Viva.
3 years
Waist Circumference
Time Frame: 7 years
Research staff measured children's waist circumference in Project Viva.
7 years
Waist Circumference
Time Frame: 12-13 years
Research staff measured children's waist circumference in Project Viva.
12-13 years
Waist Circumference
Time Frame: 14-15 years
Research staff measured children's waist circumference in Project Viva.
14-15 years
Skinfold thickness
Time Frame: 3 years
Research staff measured children's skinfold thickness in Project Viva.
3 years
Skinfold thickness
Time Frame: 7 years
Research staff measured children's skinfold thickness in Project Viva.
7 years
Skinfold thickness
Time Frame: 12-13 years
Research staff measured children's skinfold thickness in Project Viva.
12-13 years
Skinfold thickness
Time Frame: 14-15 years
Research staff measured children's skinfold thickness in Project Viva.
14-15 years
Fat mass
Time Frame: 7 years
Research staff measured children's fat mass in Project Viva.
7 years
Fat mass
Time Frame: 12-13 years
Research staff measured children's fat mass in Project Viva.
12-13 years
Fat mass
Time Frame: 14-15 years
Research staff measured children's fat mass in Project Viva.
14-15 years
Lean mass
Time Frame: 7 years
Research staff measured children's lean mass in Project Viva.
7 years
Lean mass
Time Frame: 12-13 years
Research staff measured children's lean mass in Project Viva.
12-13 years
Lean mass
Time Frame: 14-15 years
Research staff measured children's lean mass in Project Viva.
14-15 years
Trunk fat mass
Time Frame: 7 years
Research staff measured children's trunk fat mass in Project Viva.
7 years
Trunk fat mass
Time Frame: 12-13 years
Research staff measured children's trunk fat mass in Project Viva.
12-13 years
Trunk fat mass
Time Frame: 14-15 years
Research staff measured children's trunk fat mass in Project Viva.
14-15 years
Systolic blood pressure
Time Frame: 7 years (mid-childhood)
Research staff measured children's systolic blood pressure in Project Viva.
7 years (mid-childhood)
Systolic blood pressure
Time Frame: 12-13 years (early teen)
Research staff measured children's systolic blood pressure in Project Viva.
12-13 years (early teen)
Systolic blood pressure
Time Frame: 14-15 years (mid-teen)
Research staff measured children's systolic blood pressure in Project Viva.
14-15 years (mid-teen)
Diastolic blood pressure
Time Frame: 7 years
Research staff measured children's diastolic blood pressure in Project Viva.
7 years
Diastolic blood pressure
Time Frame: 12-13 years (early teen)
Research staff measured children's diastolic blood pressure in Project Viva.
12-13 years (early teen)
Diastolic blood pressure
Time Frame: 14-15 years (mid-teen)
Research staff measured children's diastolic blood pressure in Project Viva.
14-15 years (mid-teen)
Diagnosis of food allergy
Time Frame: 2 years
Research staff measured children's food allergy in Project Viva.
2 years
Diagnosis of food allergy
Time Frame: 3 years
Research staff measured children's food allergy in Project Viva.
3 years
Diagnosis of food allergy
Time Frame: 4 years
Research staff measured children's food allergy in Project Viva.
4 years
Diagnosis of food allergy
Time Frame: 5 years
Research staff measured children's food allergy in Project Viva.
5 years
Diagnosis of food allergy
Time Frame: 6 years
Research staff measured children's food allergy in Project Viva.
6 years
Diagnosis of food allergy
Time Frame: 7 years
Research staff measured children's food allergy in Project Viva.
7 years
Diagnosis of food allergy
Time Frame: 8 years
Research staff measured children's food allergy in Project Viva.
8 years
Diagnosis of food allergy
Time Frame: 9 years
Research staff measured children's food allergy in Project Viva.
9 years
Diagnosis of food allergy
Time Frame: 10 years
Research staff measured children's food allergy in Project Viva.
10 years
Diagnosis of food allergy
Time Frame: 11 years
Research staff measured children's food allergy in Project Viva.
11 years
Diagnosis of food allergy
Time Frame: 12-13 years (early teen)
Research staff measured children's food allergy in Project Viva.
12-13 years (early teen)
Diagnosis of food allergy
Time Frame: 14-15 years (mid-teen)
Research staff measured children's food allergy in Project Viva.
14-15 years (mid-teen)
Diagnosis of food allergy
Time Frame: 2 months
In the IFPS-II mothers reported the child's food allergy.
2 months
Diagnosis of food allergy
Time Frame: 3 months
In the IFPS-II mothers reported the child's food allergy.
3 months
Diagnosis of food allergy
Time Frame: 4 months
In the IFPS-II mothers reported the child's food allergy.
4 months
Diagnosis of food allergy
Time Frame: 5 months
In the IFPS-II mothers reported the child's food allergy.
5 months
Diagnosis of food allergy
Time Frame: 6 months
In the IFPS-II mothers reported the child's food allergy.
6 months
Diagnosis of food allergy
Time Frame: 7 months
In the IFPS-II mothers reported the child's food allergy.
7 months
Diagnosis of food allergy
Time Frame: 8 months
In the IFPS-II mothers reported the child's food allergy.
8 months
Diagnosis of food allergy
Time Frame: 9 months
In the IFPS-II mothers reported the child's food allergy.
9 months
Diagnosis of food allergy
Time Frame: 10 months
In the IFPS-II mothers reported the child's food allergy.
10 months
Diagnosis of food allergy
Time Frame: 11 months
In the IFPS-II mothers reported the child's food allergy.
11 months
Diagnosis of food allergy
Time Frame: 12 months
In the IFPS-II mothers reported the child's food allergy.
12 months
Diagnosis of food allergy
Time Frame: 6 years
In the IFPS-II mothers reported the child's food allergy.
6 years
Intelligence (PPVT-III test)
Time Frame: 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.
3 years
Intelligence (KBIT-II test)
Time Frame: 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.
7 years
Visual-motor (WRAVMA)
Time Frame: 3 years
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)
Time Frame: 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.
7 years
Memory-learning
Time Frame: 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.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Egg Board

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaozhong Wen, State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings