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临床试验/NCT03341247
NCT03341247已完成不适用

Brain Mechanisms of Overeating in Children

Penn State University1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2018年1月31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
254
试验地点
1
主要终点
Brain Responses to Portion Size

研究概览

简要总结

The proposed research will follow healthy weight children who vary by family risk for obesity to identify the neurobiological and appetitive traits that are implicated in overeating and weight gain during the critical pre-adolescent period. The investigator's central hypothesis is that increased intake from large portions of energy dense foods is due in part to reduced activity in brain regions implicated in inhibitory control and decision making, combined with increased activity in reward processing pathways. To test this hypothesis, the investigators will recruit 120 healthy weight children, aged 7-8 years, at two levels of obesity risk (i.e., 60 high-risk and 60 low-risk) based on parent weight status. This will result in 240 participants: 120 children and their parents.

详细描述

In aim one, the investigators will use functional magnetic resonance imaging to characterize the brain regions which are activated in response to food portion size and compare these regions between high- and low-risk children.

Second, the investigators will determine the relationship between brain response to visual portion size cues and measured food intake when portions are increased in the laboratory.

Third, the investigators will determine the relationship between brain response to large portions and other validated measures of overeating, including satiety responsiveness and the amount of calories children consumed from high calorie snacks when they are not hungry (i.e., eating in the absence of hunger).

Fourth, the investigators will conduct follow-up visits one year after baseline to determine the extent to which baseline brain and behavioral responses to portion size predict gains in adiposity assessed by anthropometrics (body weight, height, and dual-energy x-ray absorptiometry).

Secondary study endpoints include the relationship between child behavioral and brain response to food portion size and physical activity assessed by accelerometry and questionnaires, inhibitory control assessed by a stop signal test, reward-related design making assessed by a computer task, working memory assessed by an N-back task loss of control eating, child sleep, child working memory, child meal microstructure assessed by observational meal coding, parent rated eating behaviors, and parental feeding practices.

研究设计

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

入排标准

年龄范围
7 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child is in good health based on parental self-report
  • Child has no learning disabilities (e.g., ADHD)
  • Child has no diagnosed psychological or medical conditions/devices, or metal in/on the body that may impact comfort or safety in the fMRI (e.g., anxiety, insulin pump)
  • Child is not on any medications known to influence body weight, taste, food intake, behavior, or blood flow
  • Child is not claustrophobic
  • Child is between the ages of 7-8 years-old at enrollment
  • Child's immediate family members have not been diagnosed with a psychological disorder, including depression, anxiety, schizophrenia, etc.
  • Child's biological mother and biological father have a body mass index either between 18.5 - 25 kg/m2 (low-risk group) or biological mother has a body mass index greater than or equal to 30 kg/m2 and biological father has a body mass index greater than or equal to 25 kg/m2 (high-risk group)
  • Child's parent participating in study must be available to attend visits with child

排除标准

  • Child is not in good health based on parent self-report
  • Child has any learning disabilities (e.g., ADHD)
  • Child has any psychological or medical conditions/devices that may impact comfort in the fMRI (e.g., anxiety, insulin pump)
  • Child is taking any medications known to influence body weight, taste, food intake, behavior, or blood flow
  • Child is claustrophobic
  • Child is less than 7 or greater than 8 years-old at enrollment
  • Child has any immediate family members diagnosed with a psychological disorder, including depression, anxiety, schizophrenia, etc.
  • Child's biological mother or biological father's body mass index do not fit into the parameters for either group (both biological parents < 18.5 for low-risk group or biological mother is < 30 and biological father is < 25 for high-risk group)
  • Child's parent participating in study is not available to attend visits with child
  • Child is blue/green colorblind
  • Child is not fluent in the English language

结局指标

主要结局

Brain Responses to Portion Size

时间窗: baseline

The investigators will use functional magnetic resonance imaging to characterize the brain regions which are activated in response to food portion size and compare these regions between high- and low-risk children.

Food Intake Relationship to Portion Size

时间窗: baseline

The investigators will determine the relationship between brain response to visual portion size cues and measured food intake when portions are increased in laboratory meals.

The Change in DXA analysis of child adiposity after 1 year

时间窗: From baseline visit to 1 year later

The investigators will determine the extent to which baseline brain and behavioral responses to portion size predict gains in adiposity assessed by anthropometrics (body weight, height, and dual-energy x-ray absorptiometry). Body weight (kg) and Height (m) will be aggregated to report BMI in kg/m\^2.

次要结局

  • Brain Response Relationships(baseline)
  • Inhibitory control assessed by a Stop Signal test(baseline)
  • Working memory(baseline and 1 year later)
  • Eating in the absence of hunger(baseline and 1 year later)
  • Reward-related design(baseline and 1 year later)
  • Meal microstructure(baseline and 1 year later)

研究者

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

Kathleen Loralee Keller

Director

Penn State University

研究点 (1)

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