Interoception and Eating Behaviors in Children

NCT06504654 | Completed

• 1 other identifier: STUDY00024712
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Childhood; Eating Behavior

Keywords

interoception; eating behavior; ghrelin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children 7-10 years old and their parents

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva samples will be collected at fasting and 30, 60, and 90 minutes after a meal

MeSH Terms

Conditions

Pediatric Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Professor

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: October 31, 2024
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be shared at the conclusion of the funding period (July 2027)
• Access Criteria: Data will be shared in accordance with access criteria of the selected repository (to be determined)

Locations

US (1)