Clinical trial

Development of an Eating Behavior Risk Score

Opening soon · Not applicable · 1 countries · Registry ID NCT07266506

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age7 Years to 9 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Childhood

Full registry criteria

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.

Treatments and study arms

Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological Measures

Behavioral

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.

Primary outcomes

fMRI Neural Response to Food Portion Size ImagesBaseline

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.

PACE (Portion Size Susceptibility, Appetite Awareness, Loss of Control Eating, and Eating Speed) Phenotype ScoreBaseline 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.

Child AdiposityBaseline 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.

Family Socioeconomic Status (SES)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.

PACE Phenotype Score Consistency Over TimeBaseline 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.

Study locations

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Metabolic Kitchen and Children's Eating Behavior Lab🇺🇸 State College, Pennsylvania, United States

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Kathleen L Keller, Ph.DPrincipal Investigator