Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504654
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Interoception and Eating Behaviors in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Interoception and Eating Behaviors in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
I-EAT
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 eg 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 hungersatiety 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 surveysinterview 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
Aim 1 Determine associations between interoception and non-homeostatic eating H1 Multi-systems measures of interoceptive awareness eg 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 hungersatiety 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 surveysinterview 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None