Obesity, ChildhoodI-EATNCT06504654
Interoception and Eating Behaviors in Children
An observational study of Obesity, Childhood and Eating Behavior, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Eating Behavior
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children 7-10 years old and their parents
Who may be able to join
- 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
Who cannot join
- BMI for age <5th percentile
- Monogenic obesity condition (e.g., Prader Willi syndrome)
- Autism/autism spectrum disorder
- Developmental delay
- Eating disorder
- Diabetes
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
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.
Read the 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.
- Conditions
- Obesity, Childhood, Eating Behavior
- Keywords
- interoception, eating behavior, ghrelin
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visit 2 (1-3 weeks after enrollment at Visit 1)
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Visit 1 (Enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start31 Oct 2024
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Hohman, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504654
- Sponsor's protocol ID
- STUDY00024712
- Acronym
- I-EAT
- Status last verified
- Apr 2026
- First submitted
- 10 Jul 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared in a repository at the end of the study
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interoception and Eating Behaviors in Children
- ClinicalTrials.gov ID
- NCT06504654
- Acronym / sponsor ID
- I-EAT / STUDY00024712
- Conditions
- Obesity, Childhood, Eating Behavior
- Keywords
- interoception, eating behavior, ghrelin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children 7-10 years old and their parents
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- BMI for age <5th percentile
- Monogenic obesity condition (e.g., Prader Willi syndrome)
- Autism/autism spectrum disorder
- Developmental delay
- Eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kcal consumed in the Eating in the Absence of Hunger protocol
Time frame: 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
5 secondary outcomes
Pattern of salivary ghrelin in response to a meal
Time frame: Visit 2 (1-3 weeks after enrollment at Visit 1)
Pattern of salivary leptin in response to a meal
Time frame: Visit 2 (1-3 weeks after enrollment at Visit 1)
Heart beat counting accuracy
Time frame: Visit 1 (Enrollment)
Gastric interoception
Time frame: Visit 1 (Enrollment)
Multidimensional Assessment of Interoceptive Awareness (MAIA)-youth version
Time frame: Visit 1 (Enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared in a repository at the end of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood and Eating Behavior, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kcal consumed in the Eating in the Absence of Hunger protocol (time frame: Visit 2 (1-3 weeks after enrollment at Visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.