ClinicalTrials.Veeva

Menu

Interoception and Eating Behaviors in Children (I-EAT)

The Pennsylvania State University (PENNSTATE) logo

The Pennsylvania State University (PENNSTATE)

Status

Begins enrollment this month

Conditions

Eating Behavior
Obesity, Childhood

Study type

Observational

Funder types

Other

Identifiers

NCT06504654
STUDY00024712

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

7+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • 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

Exclusion Criteria (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
  • Diabetes
  • 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

Trial contacts and locations

0

Loading...

Central trial contact

Emily Hohman, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems