Interoception and Eating Behaviors in Children (I-EAT)

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood; Eating Behavior

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children 7-10 years old and their parents

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kcal consumed in the Eating in the Absence of Hunger protocol	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	Visit 2 (1-3 weeks after enrollment at Visit 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pattern of salivary ghrelin in response to a meal	Children will provide saliva samples at fasting, +30 minutes, +60 minutes, and +90 minutes from start of a meal, which will be analyzed for active ghrelin	Visit 2 (1-3 weeks after enrollment at Visit 1)
Pattern of salivary leptin in response to a meal	Children will provide saliva samples at fasting, +30 minutes, +60 minutes, and +90 minutes from the start of a meal, which will be analyzed for leptin	Visit 2 (1-3 weeks after enrollment at Visit 1)
Heart beat counting accuracy	Participants will be fitted with a heart rate monitor and will be asked to count their heartbeat over several time intervals. Reported counts will be compared to measured heart rate to determine percent accuracy	Visit 1 (Enrollment)
Gastric interoception	Children will be asked to drink plain water until their stomach feels 'just right', and then will be asked to drink further water until their stomach feels maximally full. The amount of water consumed in each phase will be measured by changes in weight of the water bottle. The ratio of the two volumes is a measure of gastric interoception that is not confounded by stomach capacity	Visit 1 (Enrollment)
Multidimensional Assessment of Interoceptive Awareness (MAIA)-youth version	Children will complete a questionnaire via interview to assess their perception of their interoceptive awareness	Visit 1 (Enrollment)

Collaborators and Investigators

• Sponsor: Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Actual): April 15, 2026
• Study Completion (Actual): April 15, 2026

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ghrelin; eating behavior; interoception
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Behavior, Animal; Pediatric Obesity; Feeding Behavior
• Other Study ID Numbers: STUDY00024712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be shared in a repository at the end of the study
• IPD Sharing Time Frame: Data will be shared at the conclusion of the funding period (July 2027)
• IPD Sharing Access Criteria: Data will be shared in accordance with access criteria of the selected repository (to be determined)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No