Pennsylvania State University
University Park, Pennsylvania, 16802, United States
NCT Number: NCT06504654
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.
Looking for future studies?
Notify Me7 year and older
All sexes
Observational
University Park, Pennsylvania, 16802, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(all applicable to child only):
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
Time frame: Visit 2 (1-3 weeks after enrollment at Visit 1)
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
Time frame: Visit 2 (1-3 weeks after enrollment at Visit 1)
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
Time frame: Visit 1 (Enrollment)
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
Time frame: Visit 1 (Enrollment)
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
Time frame: Visit 1 (Enrollment)
Children will complete a questionnaire via interview to assess their perception of their interoceptive awareness
Penn State University
Other
Acronym: I-EAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05456516
Behavior, Behavior, Animal
University Park, Pennsylvania, United States
View Trial DetailsNCT04477577
Behavior, Behavior, Animal
Boston, Massachusetts, United States
View Trial DetailsNCT05225350
Behavior, Behavior, Animal
Halmstad, Halland County, Sweden
View Trial DetailsNCT03170700
Behavior, Behavior, Animal
Fort Collins, Colorado, United States
View Trial Details