Growth & DevelopmentNCT04345185
Effects of Infant Egg Consumption on Child Health and Cognition Development
An observational study of Growth & Development and Obesity, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth & Development, Obesity, Cardiovascular Risk Factor
- What is being tested?
- Infant egg consumption (i.e., age of introduction and frequency of intake)
- How many people
- 5,374 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 1999to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Children with complete data on infant egg consumption and the corresponding health and cognition outcomes.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
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
About this study
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.
Read the 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.
- Conditions
- Growth & Development, Obesity, Cardiovascular Risk Factor, Metabolic Syndrome, Food Allergy, Cognitive Developmental Delay
- Being tested
- Infant egg consumption (i.e., age of introduction and frequency of intake)
- Medical subject headings
- Obesity, Metabolic Syndrome, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant egg consumption (i.e., age of introduction and frequency of intake)Other
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Infant egg consumption (i.e., age of introduction and frequency of intake) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Research staff measured children's weight in Project Viva.
Measured: At 6 months (infancy)
Weight
Research staff measured children's weight in Project Viva.
Measured: 3 years (early childhood)
Weight
Research staff measured children's weight in Project Viva.
Measured: 7 years (mid-childhood)
Weight
Research staff measured children's weight in Project Viva.
Measured: 12-13 years (early teen)
Weight
Research staff measured children's weight in Project Viva.
Measured: 14-15 years (mid-teen)
Weight
In IFPS II, mothers reported infant weight in survey.
Measured: 3 months
Weight
In IFPS II, mothers reported infant weight survey.
Measured: 5 months
Weight
In IFPS II, mothers reported infant weight in survey.
Measured: 7 months
Weight
In IFPS II, mothers reported infant weight in survey.
Measured: 12 months
Weight
In IFPS II, mothers reported infant weight in survey.
Measured: 6 years
Height
Research staff measured children's height in Project Viva.
Measured: 6 months
Height
Research staff measured children's height in Project Viva.
Measured: 3 years
Height
Research staff measured children's height in Project Viva.
Measured: 7 years
Height
Research staff measured children's height in Project Viva.
Measured: 12-13 years
Height
Research staff measured children's height in Project Viva.
Measured: 14-15 years
Height
In IFPS II, mothers reported infant height in survey.
Measured: 3 months
Height
In IFPS II, mothers reported infant height in survey.
Measured: 5 months
Height
In IFPS II, mothers reported infant height in survey.
Measured: 7 months
Height
In IFPS II, mothers reported infant height in survey.
Measured: 12 months
Height
In IFPS II, mothers reported infant height in survey.
Measured: 6 years
Waist Circumference
Research staff measured children's waist circumference in Project Viva.
Measured: 6 months
Waist Circumference
Research staff measured children's waist circumference in Project Viva.
Measured: 3 years
Waist Circumference
Research staff measured children's waist circumference in Project Viva.
Measured: 7 years
Waist Circumference
Research staff measured children's waist circumference in Project Viva.
Measured: 12-13 years
Waist Circumference
Research staff measured children's waist circumference in Project Viva.
Measured: 14-15 years
Skinfold thickness
Research staff measured children's skinfold thickness in Project Viva.
Measured: 3 years
Skinfold thickness
Research staff measured children's skinfold thickness in Project Viva.
Measured: 7 years
Skinfold thickness
Research staff measured children's skinfold thickness in Project Viva.
Measured: 12-13 years
Skinfold thickness
Research staff measured children's skinfold thickness in Project Viva.
Measured: 14-15 years
Fat mass
Research staff measured children's fat mass in Project Viva.
Measured: 7 years
Fat mass
Research staff measured children's fat mass in Project Viva.
Measured: 12-13 years
Fat mass
Research staff measured children's fat mass in Project Viva.
Measured: 14-15 years
Lean mass
Research staff measured children's lean mass in Project Viva.
Measured: 7 years
Lean mass
Research staff measured children's lean mass in Project Viva.
Measured: 12-13 years
Lean mass
Research staff measured children's lean mass in Project Viva.
Measured: 14-15 years
Trunk fat mass
Research staff measured children's trunk fat mass in Project Viva.
Measured: 7 years
Trunk fat mass
Research staff measured children's trunk fat mass in Project Viva.
Measured: 12-13 years
Trunk fat mass
Research staff measured children's trunk fat mass in Project Viva.
Measured: 14-15 years
Systolic blood pressure
Research staff measured children's systolic blood pressure in Project Viva.
Measured: 7 years (mid-childhood)
Systolic blood pressure
Research staff measured children's systolic blood pressure in Project Viva.
Measured: 12-13 years (early teen)
Systolic blood pressure
Research staff measured children's systolic blood pressure in Project Viva.
Measured: 14-15 years (mid-teen)
Diastolic blood pressure
Research staff measured children's diastolic blood pressure in Project Viva.
Measured: 7 years
Diastolic blood pressure
Research staff measured children's diastolic blood pressure in Project Viva.
Measured: 12-13 years (early teen)
Diastolic blood pressure
Research staff measured children's diastolic blood pressure in Project Viva.
Measured: 14-15 years (mid-teen)
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 2 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 3 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 4 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 5 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 6 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 7 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 8 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 9 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 10 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 11 years
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 12-13 years (early teen)
Diagnosis of food allergy
Research staff measured children's food allergy in Project Viva.
Measured: 14-15 years (mid-teen)
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 2 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 3 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 4 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 5 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 6 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 7 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 8 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 9 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 10 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 11 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 12 months
Diagnosis of food allergy
In the IFPS-II mothers reported the child's food allergy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Jan 1999
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth & DevelopmentStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,374 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Xiaozhong Wen, State University of New York at Buffalo
- Investigators
- Xiaozhong Wen, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345185
- Sponsor's protocol ID
- STUDY00004022
- Status last verified
- Oct 2020
- First submitted
- 4 Apr 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Infant Egg Consumption on Child Health and Cognition Development
- ClinicalTrials.gov ID
- NCT04345185
- Acronym / sponsor ID
- STUDY00004022
- Conditions
- Growth & Development, Obesity, Cardiovascular Risk Factor, Metabolic Syndrome, Food Allergy, Cognitive Developmental Delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,374 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project Viva | – | Other: Infant egg consumption (i.e., age of introduction and frequency of intake)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 | – | Other: Infant egg consumption (i.e., age of introduction and frequency of intake)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. |
Who may qualify
- Ages
- 0 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children with complete data on infant egg consumption and the corresponding health and cognition outcomes.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant egg consumption (i.e., age of introduction and frequency of intake) | Other | Infant Feeding Practices Study II, Project Viva |
Primary outcome
Weight
Time frame: At 6 months (infancy)
Research staff measured children's weight in Project Viva.
Weight
Time frame: 3 years (early childhood)
Research staff measured children's weight in Project Viva.
Weight
Time frame: 7 years (mid-childhood)
Research staff measured children's weight in Project Viva.
Weight
Time frame: 12-13 years (early teen)
Research staff measured children's weight in Project Viva.
Weight
Time frame: 14-15 years (mid-teen)
Research staff measured children's weight in Project Viva.
Weight
Time frame: 3 months
In IFPS II, mothers reported infant weight in survey.
Weight
Time frame: 5 months
In IFPS II, mothers reported infant weight survey.
Weight
Time frame: 7 months
In IFPS II, mothers reported infant weight in survey.
Weight
Time frame: 12 months
In IFPS II, mothers reported infant weight in survey.
Weight
Time frame: 6 years
In IFPS II, mothers reported infant weight in survey.
Height
Time frame: 6 months
Research staff measured children's height in Project Viva.
Height
Time frame: 3 years
Research staff measured children's height in Project Viva.
Height
Time frame: 7 years
Research staff measured children's height in Project Viva.
Height
Time frame: 12-13 years
Research staff measured children's height in Project Viva.
Height
Time frame: 14-15 years
Research staff measured children's height in Project Viva.
Height
Time frame: 3 months
In IFPS II, mothers reported infant height in survey.
Height
Time frame: 5 months
In IFPS II, mothers reported infant height in survey.
Height
Time frame: 7 months
In IFPS II, mothers reported infant height in survey.
Height
Time frame: 12 months
In IFPS II, mothers reported infant height in survey.
Height
Time frame: 6 years
In IFPS II, mothers reported infant height in survey.
Waist Circumference
Time frame: 6 months
Research staff measured children's waist circumference in Project Viva.
Waist Circumference
Time frame: 3 years
Research staff measured children's waist circumference in Project Viva.
Waist Circumference
Time frame: 7 years
Research staff measured children's waist circumference in Project Viva.
Waist Circumference
Time frame: 12-13 years
Research staff measured children's waist circumference in Project Viva.
Waist Circumference
Time frame: 14-15 years
Research staff measured children's waist circumference in Project Viva.
Skinfold thickness
Time frame: 3 years
Research staff measured children's skinfold thickness in Project Viva.
Skinfold thickness
Time frame: 7 years
Research staff measured children's skinfold thickness in Project Viva.
Skinfold thickness
Time frame: 12-13 years
Research staff measured children's skinfold thickness in Project Viva.
Skinfold thickness
Time frame: 14-15 years
Research staff measured children's skinfold thickness in Project Viva.
Fat mass
Time frame: 7 years
Research staff measured children's fat mass in Project Viva.
Fat mass
Time frame: 12-13 years
Research staff measured children's fat mass in Project Viva.
Fat mass
Time frame: 14-15 years
Research staff measured children's fat mass in Project Viva.
Lean mass
Time frame: 7 years
Research staff measured children's lean mass in Project Viva.
Lean mass
Time frame: 12-13 years
Research staff measured children's lean mass in Project Viva.
Lean mass
Time frame: 14-15 years
Research staff measured children's lean mass in Project Viva.
Trunk fat mass
Time frame: 7 years
Research staff measured children's trunk fat mass in Project Viva.
Trunk fat mass
Time frame: 12-13 years
Research staff measured children's trunk fat mass in Project Viva.
Trunk fat mass
Time frame: 14-15 years
Research staff measured children's trunk fat mass in Project Viva.
Systolic blood pressure
Time frame: 7 years (mid-childhood)
Research staff measured children's systolic blood pressure in Project Viva.
Systolic blood pressure
Time frame: 12-13 years (early teen)
Research staff measured children's systolic blood pressure in Project Viva.
Systolic blood pressure
Time frame: 14-15 years (mid-teen)
Research staff measured children's systolic blood pressure in Project Viva.
Diastolic blood pressure
Time frame: 7 years
Research staff measured children's diastolic blood pressure in Project Viva.
Diastolic blood pressure
Time frame: 12-13 years (early teen)
Research staff measured children's diastolic blood pressure in Project Viva.
Diastolic blood pressure
Time frame: 14-15 years (mid-teen)
Research staff measured children's diastolic blood pressure in Project Viva.
Diagnosis of food allergy
Time frame: 2 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 3 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 4 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 5 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 6 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 7 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 8 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 9 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 10 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 11 years
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 12-13 years (early teen)
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 14-15 years (mid-teen)
Research staff measured children's food allergy in Project Viva.
Diagnosis of food allergy
Time frame: 2 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 3 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 4 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 5 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 6 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 7 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 8 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 9 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 10 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 11 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 12 months
In the IFPS-II mothers reported the child's food allergy.
Diagnosis of food allergy
Time frame: 6 years
In the IFPS-II mothers reported the child's food allergy.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaozhong Wen principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth & Development and Obesity, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: At 6 months (infancy)). The study lists 73 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.