Clinical trial NCT06504654: Interoception and Eating Behaviors in Children
Official title: Interoception and Eating Behaviors in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Childhood
Eating Behavior
Keywords: interoception
eating behavior
ghrelin
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 7-10 years old and their parents

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.

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.

Eligibility 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

Primary outcomes:
measure: Kcal consumed in the Eating in the Absence of Hunger protocol
timeFrame: Visit 2 (1-3 weeks after enrollment at Visit 1)
Secondary outcomes:
measure: Pattern of salivary ghrelin in response to a meal
timeFrame: Visit 2 (1-3 weeks after enrollment at Visit 1)
measure: Pattern of salivary leptin in response to a meal
timeFrame: Visit 2 (1-3 weeks after enrollment at Visit 1)
measure: Heart beat counting accuracy
timeFrame: Visit 1 (Enrollment)
measure: Gastric interoception
timeFrame: Visit 1 (Enrollment)
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)-youth version
timeFrame: Visit 1 (Enrollment)
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
References: