跳至主要内容
临床试验/NCT04345185
NCT04345185已完成不适用

Effects of Infant Egg Consumption on Child Health and Cognition Development

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 5,374 人开始时间: 1999年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,374
试验地点
1
主要终点
Fat mass

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Fat mass

时间窗: 14-15 years

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

Lean mass

时间窗: 14-15 years

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

Trunk fat mass

时间窗: 14-15 years

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

Systolic blood pressure

时间窗: 14-15 years (mid-teen)

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

Diastolic blood pressure

时间窗: 14-15 years (mid-teen)

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

Weight

时间窗: 6 years

In IFPS II, mothers reported infant weight in survey.

Height

时间窗: 6 years

In IFPS II, mothers reported infant height in survey.

Waist Circumference

时间窗: 14-15 years

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

Skinfold thickness

时间窗: 14-15 years

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

Diagnosis of food allergy

时间窗: 6 years

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

Intelligence (PPVT-III test)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaozhong Wen

Principal Investigator

State University of New York at Buffalo

研究点 (1)

Loading locations...

相似试验