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临床试验/NCT06504654
NCT06504654已完成不适用

Interoception and Eating Behaviors in Children

Penn State University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年10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
120
试验地点
2
主要终点
Kcal consumed in the Eating in the Absence of Hunger protocol

研究概览

简要总结

The purpose of this study is to examine how individual differences in interoception (the ability to sense, interpret, and act on bodily feelings like hunger, fullness, thirst, hot, cold, etc.) relate to eating behaviors in children ages 7-10 years. Findings will inform whether interventions targeting interoceptive awareness may be helpful for prevention of obesity and related chronic diseases.

详细描述

The overall goal of this project is to examine if interoception (the process by which internal bodily states, like hunger and fullness, are sensed, integrated, interpreted, and regulated) is associated with BMI and obesity-related eating behaviors in children age 7-10 years. The specific aims are:

Aim 1: Determine associations between interoception and non-homeostatic eating H1: Multi-systems measures of interoceptive awareness (e.g., heartbeat perception, gastric interoception, self-reported interoceptive awareness) will be inversely associated with intake (kcal) in the eating in the absence of hunger (EAH) task

Aim 2: Assess salivary ghrelin and leptin as interoceptive signals of hunger/satiety H1: Children with greater postprandial suppression of ghrelin will eat less in the EAH task H2: Children with greater postprandial suppression of ghrelin will have better interoceptive awareness H3: Children with higher leptin will exhibit less sensitivity to changes in ghrelin

Aim 3 (Exploratory): Identify interoceptive phenotypes that may predict obesity risk Using k-means cluster analysis, we aim to identify subgroups of individuals who exhibit different combinations of interoceptive variables. We will then examine differences in eating behavior and weight between clusters.

Participants will attend two study visits at the Clinical Research Center at Penn State University Park campus. At the first visit, children will have their height, weight, and body composition measured, complete measures of interoception, and complete surveys/interview. Parents will complete a survey. At the second visit, children will eat a meal, taste snacks, provide saliva samples, and play cognitive games on a tablet.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Child must be 7-10 years of age
  • Participating parent must be at least 18 years of age, but there is no upper age limit
  • Able to understand and answer questions in English

排除标准

  • (all applicable to child only):
  • BMI for age <5th percentile
  • Monogenic obesity condition (e.g., Prader Willi syndrome)
  • Autism/autism spectrum disorder
  • Developmental delay
  • Eating disorder
  • Heart condition
  • Taking medications impacting appetite (e.g., stimulants, weight control medications)
  • Any other condition significantly impacting growth, eating behavior, or cardiac function
  • Allergy or dietary restriction to study foods
  • Severe/untreated oral/dental health problems
  • Orthodontic procedure or adjustment of braces within the past omonth
  • Oral surgery or major oral/dental procedure within past month
  • Had an x-ray within the past month

结局指标

主要结局

Kcal consumed in the Eating in the Absence of Hunger protocol

时间窗: Visit 2 (1-3 weeks after enrollment at Visit 1)

Children will be provide with an array of snacks following a meal and will have 10 minutes to consume any snacks that they would like. Intake will be measured by pre- and post-weighing snacks

次要结局

  • Pattern of salivary ghrelin in response to a meal(Visit 2 (1-3 weeks after enrollment at Visit 1))
  • Pattern of salivary leptin in response to a meal(Visit 2 (1-3 weeks after enrollment at Visit 1))
  • Heart beat counting accuracy(Visit 1 (Enrollment))
  • Gastric interoception(Visit 1 (Enrollment))
  • Multidimensional Assessment of Interoceptive Awareness (MAIA)-youth version(Visit 1 (Enrollment))

研究者

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

Emily Hohman

Associate Research Professor

Penn State University

研究点 (2)

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