Metabolic Kitchen and Children's Eating Behavior Lab
State College, Pennsylvania, 16802, United States
Location contact
Kathleen L Keller, Ph.D
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07266506
This study will explore how children's eating behaviors are connected to brain activity and body fat levels. Researchers are especially interested in a behavior pattern called the PACE phenotype, which includes how much children eat when offered large portions, how quickly they eat, their appetite traits, and their ability to control eating. The goal is to better understand why some children are more likely to gain weight than others.
The study will include children between the ages of 7 and 9 and will follow them for one year. Researchers will use brain scans, lab-based meal observations, and questionnaires to study how children respond to food and how their eating patterns relate to body fat at the start of the study and one year later. The study will also look at how family background, parenting, and other factors might protect some children from gaining excess weight even if they show risky eating behaviors. Results may help identify which children are most at risk for obesity and guide future strategies for prevention.
Trial opening soon.
Get Notified7 year–9 year
All sexes
Interventional
Not applicable
State College, Pennsylvania, 16802, United States
Kathleen L Keller, Ph.D
PRINCIPAL_INVESTIGATOR
This is a one-year observational study designed to better understand how certain eating behaviors in children relate to brain function and weight gain over time. These behaviors will be assessed using a combination of laboratory meal tasks, caregiver questionnaires, and behavioral coding. Children will be invited to six research visits-four at the beginning of the study and two 12 months later-during which they will participate in structured meals where portion sizes are adjusted, complete computer-based and paper assessments, and undergo brain imaging while viewing pictures of food. Body composition will be measured at both timepoints using a DXA scan. In addition, researchers will collect information on children's sleep, physical activity, executive function, dietary intake, and interoceptive awareness. Parents will be asked to complete surveys about their family's socioeconomic background, food security, feeding practices, and their child's behavior, temperament, and development. One of the study's goals is to examine how brain regions involved in appetite regulation and self-control respond to food cues in children with different PACE scores. Another goal is to determine whether children with higher PACE scores tend to have more body fat and whether those scores predict changes in body fat over one year. The study will also explore whether children from families with higher or lower socioeconomic status show different patterns of risk. Finally, researchers will use a machine learning approach to identify children who seem resilient to weight gain, despite having high-risk eating patterns, and to better understand what family or individual characteristics might explain that resilience.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Children :
Parents :
Exclusion criteria
Children :
Parents :
This study does not involve an active intervention. The exposures of interest include the children's eating behaviors as measured by the PACE phenotype score, which encompasses portion size responsiveness, appetite traits, loss of control eating, and eating rate. Brain responses to food cues assessed by fMRI, body composition measured by DXA, and family socioeconomic status will also be evaluated as key exposures. These measures will be collected at baseline and at 12-month follow-up to examine associations with adiposity and behavioral outcomes.
Time frame: Baseline
Functional magnetic resonance imaging (fMRI) will be used to measure brain activation in response to images of palatable, energy-dense food portions of varying sizes. Activation will be assessed in brain regions involved in visceral interoception (e.g., insula, cerebellum) and self-regulation (e.g., dorsolateral prefrontal cortex). These neural responses will be correlated with children's PACE phenotype scores to explore neurobiological underpinnings of eating behaviors.
Time frame: Baseline and 12-month follow-up
The PACE score will be calculated as a composite measure including: 1) children's food intake during two laboratory meals with varying portion sizes, 2) parent-reported appetite traits via the Children's Eating Behavior Questionnaire, 3) loss of control eating measured with the Pediatric Eating Disorder Screener, and 4) eating rate quantified through video-recorded meals and behavioral coding of bite rate and eating speed. This score reflects obesogenic eating phenotypes.
Time frame: Baseline and 12-month follow-up
Child body fat percentage and adiposity will be measured using DXA scans, a validated imaging technique providing precise assessment of body composition. This measure will serve as the primary dependent variable to evaluate associations with PACE phenotype and changes over time.
Time frame: Baseline
Family SES will be assessed via parent self-report questionnaires, including family income levels and parental educational attainment. SES will be analyzed as a moderator of the relationship between PACE scores and child adiposity to explore social determinants of obesity risk.
Time frame: Baseline and 12-month follow-up
PACE scores obtained at baseline and 12-month follow-up will be compared to evaluate the stability and trajectory of obesogenic eating behaviors in children over one year.
Time frame: Baseline
Parent-reported information on the child's race and ethnicity collected via standardized questionnaire to capture demographic diversity and potential confounding factors.
Time frame: Baseline
Highest level of education completed by parents, self-reported, to help understand socioeconomic context and potential impact on child health and behavior.
Time frame: Baseline
Highest level of education completed by parents, self-reported, to help understand socioeconomic context and potential impact on child health and behavior.
Time frame: Baseline
Parent-reported assessment of food security in the household using a validated food security questionnaire, to examine potential impact on child eating behaviors and adiposity.
Time frame: Baseline
Determined by family home zip code to classify rural versus urban residency, assessing environmental influences on child health and behavior.
Time frame: Baseline
Parent questionnaires assessing feeding styles, strategies, and control over child's food intake, providing insight into family eating environment.
Time frame: Baseline
Parent assessment of child's appetite-related behaviors using standardized questionnaires to capture tendencies influencing eating patterns.
Time frame: Baseline
Parent-reported measures of child temperament characteristics to explore behavioral factors that might influence eating and activity.
Time frame: Baseline
Pubertal development stage assessed by parent report using Tanner scale, to account for physiological maturation impacting metabolism and behavior.
Time frame: Baseline
Parent-reported child sleep duration and quality via standardized sleep questionnaires to evaluate potential effects on weight and behavior.
Time frame: Baseline
Direct child assessment of executive functions such as working memory, attention, and cognitive flexibility using the NIH Toolbox standardized tests.
Time frame: Baseline
Standardized assessment of child intelligence quotient using WASI-II.
Time frame: Through study completion, an average of 1 year
Child's hedonic ratings of food items consumed during laboratory meals to assess preferences influencing intake.
Time frame: Through study completion, an average of 1 year
Child's ratings of liking and wanting for foods presented during fMRI scans to correlate brain activation with subjective food reward.
Time frame: Through study completion, an average of 1 year
Child self-reported hunger and fullness before meals using visual analog scales to control for appetite state during intake measures.
Time frame: Baseline
Assessment of child's awareness of internal bodily signals via heartbeat perception task, indicating sensitivity to visceral cues potentially linked to eating behavior.
Time frame: Baseline
Child self-reported questionnaire measuring awareness of internal bodily sensations relevant to appetite and satiety.
Time frame: Baseline
Objective measurement of physical activity through accelerometer devices combined with parent and child questionnaires to quantify movement levels.
Time frame: Baseline
Sleep duration in hours per night
Time frame: Baseline
Amount of food consumed by the child during a standardized meal in the laboratory setting to assess baseline intake independent of portion manipulation.
Time frame: Baseline
Measurement of child's consumption of palatable snacks offered after a meal when not hungry, assessing loss of control or hedonic eating.
Time frame: Baseline
Behavioral task evaluating the motivational value of food compared to alternative rewards, indicating reward sensitivity.
Time frame: Baseline
Sleep fragmentation index is the number of 1 minute bouts of sleep divided by the total sleep time. Higher scores equal worse quality sleep.
Time frame: Baseline
Percent of time in bed that is spent asleep, with higher scores equal to better quality sleep.
Time frame: Baseline
Minutes awake after onset of sleep.
Contact information is provided by the study sponsor or research team.
Penn State University
Other
Acronym: PACE
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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.
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