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Completed

NCT Number: NCT04345185

Effects of Infant Egg Consumption on Child Health and Cognition Development

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.

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Key information

Conditions

Growth & Development Body Weight Cardiovascular Risk Factor Cognitive Developmental Delay Food Allergy Food Hypersensitivity Glucose Metabolism Disorders Hyperinsulinism Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

0 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

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

Other

Primary outcomes

  1. Weight

    Time frame: At 6 months (infancy)

    Research staff measured children's weight in Project Viva.

  2. Weight

    Time frame: 3 years (early childhood)

    Research staff measured children's weight in Project Viva.

  3. Weight

    Time frame: 7 years (mid-childhood)

    Research staff measured children's weight in Project Viva.

  4. Weight

    Time frame: 12-13 years (early teen)

    Research staff measured children's weight in Project Viva.

  5. Weight

    Time frame: 14-15 years (mid-teen)

    Research staff measured children's weight in Project Viva.

  6. Weight

    Time frame: 3 months

    In IFPS II, mothers reported infant weight in survey.

  7. Weight

    Time frame: 5 months

    In IFPS II, mothers reported infant weight survey.

  8. Weight

    Time frame: 7 months

    In IFPS II, mothers reported infant weight in survey.

  9. Weight

    Time frame: 12 months

    In IFPS II, mothers reported infant weight in survey.

  10. Weight

    Time frame: 6 years

    In IFPS II, mothers reported infant weight in survey.

  11. Height

    Time frame: 6 months

    Research staff measured children's height in Project Viva.

  12. Height

    Time frame: 3 years

    Research staff measured children's height in Project Viva.

  13. Height

    Time frame: 7 years

    Research staff measured children's height in Project Viva.

  14. Height

    Time frame: 12-13 years

    Research staff measured children's height in Project Viva.

  15. Height

    Time frame: 14-15 years

    Research staff measured children's height in Project Viva.

  16. Height

    Time frame: 3 months

    In IFPS II, mothers reported infant height in survey.

  17. Height

    Time frame: 5 months

    In IFPS II, mothers reported infant height in survey.

  18. Height

    Time frame: 7 months

    In IFPS II, mothers reported infant height in survey.

  19. Height

    Time frame: 12 months

    In IFPS II, mothers reported infant height in survey.

  20. Height

    Time frame: 6 years

    In IFPS II, mothers reported infant height in survey.

  21. Waist Circumference

    Time frame: 6 months

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

  22. Waist Circumference

    Time frame: 3 years

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

  23. Waist Circumference

    Time frame: 7 years

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

  24. Waist Circumference

    Time frame: 12-13 years

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

  25. Waist Circumference

    Time frame: 14-15 years

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

  26. Skinfold thickness

    Time frame: 3 years

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

  27. Skinfold thickness

    Time frame: 7 years

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

  28. Skinfold thickness

    Time frame: 12-13 years

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

  29. Skinfold thickness

    Time frame: 14-15 years

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

  30. Fat mass

    Time frame: 7 years

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

  31. Fat mass

    Time frame: 12-13 years

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

  32. Fat mass

    Time frame: 14-15 years

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

  33. Lean mass

    Time frame: 7 years

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

  34. Lean mass

    Time frame: 12-13 years

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

  35. Lean mass

    Time frame: 14-15 years

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

  36. Trunk fat mass

    Time frame: 7 years

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

  37. Trunk fat mass

    Time frame: 12-13 years

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

  38. Trunk fat mass

    Time frame: 14-15 years

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

  39. Systolic blood pressure

    Time frame: 7 years (mid-childhood)

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

  40. Systolic blood pressure

    Time frame: 12-13 years (early teen)

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

  41. Systolic blood pressure

    Time frame: 14-15 years (mid-teen)

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

  42. Diastolic blood pressure

    Time frame: 7 years

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

  43. Diastolic blood pressure

    Time frame: 12-13 years (early teen)

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

  44. Diastolic blood pressure

    Time frame: 14-15 years (mid-teen)

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

  45. Diagnosis of food allergy

    Time frame: 2 years

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

  46. Diagnosis of food allergy

    Time frame: 3 years

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

  47. Diagnosis of food allergy

    Time frame: 4 years

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

  48. Diagnosis of food allergy

    Time frame: 5 years

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

  49. Diagnosis of food allergy

    Time frame: 6 years

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

  50. Diagnosis of food allergy

    Time frame: 7 years

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

  51. Diagnosis of food allergy

    Time frame: 8 years

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

  52. Diagnosis of food allergy

    Time frame: 9 years

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

  53. Diagnosis of food allergy

    Time frame: 10 years

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

  54. Diagnosis of food allergy

    Time frame: 11 years

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

  55. Diagnosis of food allergy

    Time frame: 12-13 years (early teen)

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

  56. Diagnosis of food allergy

    Time frame: 14-15 years (mid-teen)

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

  57. Diagnosis of food allergy

    Time frame: 2 months

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

  58. Diagnosis of food allergy

    Time frame: 3 months

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

  59. Diagnosis of food allergy

    Time frame: 4 months

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

  60. Diagnosis of food allergy

    Time frame: 5 months

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

  61. Diagnosis of food allergy

    Time frame: 6 months

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

  62. Diagnosis of food allergy

    Time frame: 7 months

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

  63. Diagnosis of food allergy

    Time frame: 8 months

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

  64. Diagnosis of food allergy

    Time frame: 9 months

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

  65. Diagnosis of food allergy

    Time frame: 10 months

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

  66. Diagnosis of food allergy

    Time frame: 11 months

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

  67. Diagnosis of food allergy

    Time frame: 12 months

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

  68. Diagnosis of food allergy

    Time frame: 6 years

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

  69. 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.

  70. 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.

  71. 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.

  72. 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.

  73. 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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • American Egg Board

Registry information

Important dates

Study start
1999
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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