Development of an Eating Behavior Risk Score

N/ANot Yet RecruitingNCT07266506

Penn State University420 enrolled

Overview

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.

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.

Purpose

BASIC_SCIENCE

Conditions

Obesity Childhood

Interventions

Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological MeasuresBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Metabolic Kitchen and Children's Eating Behavior Lab

State College, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 12-month follow-up

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Parent-reported feeding practices

Parent questionnaires assessing feeding styles, strategies, and control over child's food intake, providing insight into family eating environment.

Time frame: Baseline

Parent-reported appetitive traits

Parent assessment of child's appetite-related behaviors using standardized questionnaires to capture tendencies influencing eating patterns.

Time frame: Baseline

Child temperament

Central Contacts

Kathleen L Keller, Ph.D.

CONTACT

814-863-2915 klk37@psu.edu

Data from ClinicalTrials.gov

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Parent-reported measures of child temperament characteristics to explore behavioral factors that might influence eating and activity.

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Executive functioning

Direct child assessment of executive functions such as working memory, attention, and cognitive flexibility using the NIH Toolbox standardized tests.

Time frame: Baseline

Child IQ

Standardized assessment of child intelligence quotient using WASI-II.

Time frame: Baseline

Food liking and wanting during laboratory meals

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

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Child interoceptive awareness questionnaire

Child self-reported questionnaire measuring awareness of internal bodily sensations relevant to appetite and satiety.

Time frame: 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.

Time frame: Baseline

Sleep duration assessed by accelerometry

Sleep duration in hours per night

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Sleep Efficiency Percentage

Percent of time in bed that is spent asleep, with higher scores equal to better quality sleep.

Time frame: Baseline

Wake after sleep onset (WASO)

Minutes awake after onset of sleep.

Time frame: Baseline