Development of an Eating Behavior Risk Score (PACE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Childhood
• Intervention / Treatment: Behavioral: Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological Measures

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen L Keller, Ph.D.; Phone Number: 814-863-2915; Email: klk37@psu.edu

Study Locations

• United States
  • Pennsylvania
    • State College, Pennsylvania, United States, 16802
      • Metabolic Kitchen and Children's Eating Behavior Lab
      • Principal Investigator: Kathleen L Keller, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Children :

• Children must be of good health (with the exception of obesity being allowed) based on parental self-report.
• Children should have no learning disabilities or developmental delays (e.g., ADHD, Autism, dyslexia)
• Children should speak English fluently.
• Children should not be on any medications known to influence body weight, taste, food intake, behavior, or blood flow, not be claustrophobic.
• Children should between the ages of 7-9 years-old at enrollment.
• Children must have a BMI-for-age % < 85 or ≥ 95 to be enrolled.
• The biological mother must have a BMI between 18.5 - 25.0 kg/m2 or a BMI ≥ 30.0 kg/m2. The parent primarily in charge of feeding must be able to accompany children to the visits.

Parents :

• The biological mother must have a BMI between 18.5 - 25.0 kg/m2 or a BMI ≥ 30.0 kg/m2. The parent primarily in charge of feeding must be able to accompany children to the visits.
• The parent who has the most knowledge of the child's eating behavior, media access, sleep and behavior must be available to attend the visits with their child. This would be decided among the parents.

Exclusion Criteria:

Children :

• They are not within the age requirements (< 7 years-old or > 9 years-old) at baseline.
• They are taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow.
• They are red/green colorblind.
• They do not speak English fluently.
• They report being claustrophobic, or if they have any of the following: a learning disability, ADD/ADHD, language delays, autism, dyslexia, a pre-existing medical condition such as type I or type II diabetes, rheumatoid arthritis, Cushing's syndrome, Down's syndrome, food allergies, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, or cerebral palsy.
• They have tattoos, permanent makeup, dental ware, pacemakers, or metal implants that would preclude safe completion of the MRI.
• They have received an X-ray in the previous month.
• Their BMI-for-age percentile is between 85-95th

Parents :

• The biological mother has a body mass index < 18.5 kg/m2 or between 25-29.9 kg/m2.
• The primary parent in charge of making feeding decisions is unable to attend the study visits.
• The family reports plans to move away from the area in the next year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Children in PACE Phenotype Study; A total of 210 child-parent dyads (420 participants total) will be followed for 12 months to investigate the neurobiological and behavioral aspects of the PACE eating phenotype and its relationship to adiposity in children. Children will be 7 to 9 years old, with a body mass index (BMI)-for-age percentile either below the 85th or at or above the 95th percentile. The biological mother will have a BMI categorized as either normal weight (18.5-25.0 kg/m²) or obese (≥30.0 kg/m²). The study will assess brain responses to food cues, eating behaviors, and body fat using DXA scans, along with family socioeconomic and feeding factors that may influence weight gain trajectories.

Behavioral: Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological Measures; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI Neural Response to Food Portion Size Images	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.	Baseline
PACE (Portion Size Susceptibility, Appetite Awareness, Loss of Control Eating, and Eating Speed) Phenotype Score	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.	Baseline and 12-month follow-up
Child Adiposity	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.	Baseline and 12-month follow-up
Family Socioeconomic Status (SES)	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.	Baseline
PACE Phenotype Score Consistency Over Time	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.	Baseline and 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent-reported race and ethnicity	Parent-reported information on the child's race and ethnicity collected via standardized questionnaire to capture demographic diversity and potential confounding factors.	Baseline
Parent-reported socioeconomic status	Highest level of education completed by parents, self-reported, to help understand socioeconomic context and potential impact on child health and behavior.	Baseline
Parent-reported educational attainment	Highest level of education completed by parents, self-reported, to help understand socioeconomic context and potential impact on child health and behavior.	Baseline
Food security status	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.	Baseline
Rurality of family home	Determined by family home zip code to classify rural versus urban residency, assessing environmental influences on child health and behavior.	Baseline
Parent-reported feeding practices	Parent questionnaires assessing feeding styles, strategies, and control over child's food intake, providing insight into family eating environment.	Baseline
Parent-reported appetitive traits	Parent assessment of child's appetite-related behaviors using standardized questionnaires to capture tendencies influencing eating patterns.	Baseline
Child temperament	Parent-reported measures of child temperament characteristics to explore behavioral factors that might influence eating and activity.	Baseline
Parent rating of child Tanner stage	Pubertal development stage assessed by parent report using Tanner scale, to account for physiological maturation impacting metabolism and behavior.	Baseline
Child sleep patterns (parent-reported)	Parent-reported child sleep duration and quality via standardized sleep questionnaires to evaluate potential effects on weight and behavior.	Baseline
Executive functioning	Direct child assessment of executive functions such as working memory, attention, and cognitive flexibility using the NIH Toolbox standardized tests.	Baseline
Child IQ	Standardized assessment of child intelligence quotient using WASI-II.	Baseline
Food liking and wanting during laboratory meals	Child's hedonic ratings of food items consumed during laboratory meals to assess preferences influencing intake.	Through study completion, an average of 1 year
Food liking and wanting during fMRI scanning	Child's ratings of liking and wanting for foods presented during fMRI scans to correlate brain activation with subjective food reward.	Through study completion, an average of 1 year
Pre-meal hunger and fullness ratings	Child self-reported hunger and fullness before meals using visual analog scales to control for appetite state during intake measures.	Through study completion, an average of 1 year
Child visceral interoceptive awareness	Assessment of child's awareness of internal bodily signals via heartbeat perception task, indicating sensitivity to visceral cues potentially linked to eating behavior.	Baseline
Child interoceptive awareness questionnaire	Child self-reported questionnaire measuring awareness of internal bodily sensations relevant to appetite and satiety.	Baseline
Physical activity by accelerometry and questionnaire	Objective measurement of physical activity through accelerometer devices combined with parent and child questionnaires to quantify movement levels.	Baseline
Sleep duration assessed by accelerometry	Sleep duration in hours per night	Baseline
Intake at a standard baseline meal	Amount of food consumed by the child during a standardized meal in the laboratory setting to assess baseline intake independent of portion manipulation.	Baseline
Intake of snacks and treats in the absence of hunger	Measurement of child's consumption of palatable snacks offered after a meal when not hungry, assessing loss of control or hedonic eating.	Baseline
Relative reinforcing value of food assessed on computer task	Behavioral task evaluating the motivational value of food compared to alternative rewards, indicating reward sensitivity.	Baseline
Sleep fragmentation index	Sleep fragmentation index is the number of 1 minute bouts of sleep divided by the total sleep time. Higher scores equal worse quality sleep.	Baseline
Sleep Efficiency Percentage	Percent of time in bed that is spent asleep, with higher scores equal to better quality sleep.	Baseline
Wake after sleep onset (WASO)	Minutes awake after onset of sleep.	Baseline

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: Kathleen L Keller, Ph.D., Penn State University

Publications and helpful links

Helpful Links

• Link to PACE publication

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Food-cue reactivity; Eating Behaviors; Functional magnetic resonance imaging; Appetite Regulation
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Behavior, Animal; Obesity; Feeding Behavior
• Other Study ID Numbers: STUDY00023903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No