跳至主要内容
临床试验/NCT04723264
NCT04723264进行中(未招募)不适用

The Development of Eating Behavior in Infancy: Associations With Behavior, Diet, and Growth at School Age

University of Michigan2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年4月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400
试验地点
2
主要终点
Body Mass Index z - score (BMIz)

研究概览

简要总结

This study will examine children's eating behavior. The study will enroll approximately 400 participants (200 child/parent pairs).

At certain time points, participants will engage in activities involving the presentation of food and the observation of behavioral responses to these presentations, as well as the completion of questionnaires

详细描述

This research study is a complex, long term investigation of the relationships between children's eating behaviors, and parent-child interaction during eating and their associations with BMI and dietary intake. It builds on earlier observational research which, like this research, had small experimental components used to classify children into different phenotypic groups based on different responses to the experimental conditions. The small activities and experiments of this follow up study constitute a trial as defined by NIH, registered here. The exploratory outcomes measured from these activities are not listed in this registration for reasons of scientific integrity. To be clear, the bigger structure of this research is essentially an observational follow up study with the same children who were previously studied as infants. The goal of the project is to identify potential future intervention targets.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for Children (ages 5-7.99) and their parents (18 and older):
  • Prior participation in "The Development of Eating Behavior in Infancy" project
  • Family lives within reasonable driving distance of the University of Michigan

排除标准

  • Significant developmental delays that would impede child's ability to participate
  • Foster child
  • Child has developed significant health problems that affect appetite, eating, or growth.

研究组 & 干预措施

Eating behavior activities

Experimental

干预措施: Food protocols (Behavioral)

结局指标

主要结局

Body Mass Index z - score (BMIz)

时间窗: 1- 2 years

Children will be weighed and measured using a portable stadiometer. BMI will be calculated and child BMI z-score derived using age- and sex-specific norms from Centers for Disease Control and Prevention (CDC) growth charts.

次要结局

  • Dietary Intake(1- 2 years)

研究者

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

Julie Lumeng

Thomas P Borders Family Research Professor of Child Behavior and Development, Professor of Pediatrics, Associate Dean for Research, Medical School, Professor of Nutritional Sciences

University of Michigan

研究点 (2)

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