- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345185
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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
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 |
Intervention / Treatment |
---|---|
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 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.
|
What is the study measuring?
Primary Outcome Measures
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.
Collaborators
Investigators
- 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)
January 1, 1999
Primary Completion (Actual)
November 30, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
April 4, 2020
First Submitted That Met QC Criteria
April 11, 2020
First Posted (Actual)
April 14, 2020
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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