Development of an Eating Behavior Risk Score

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.

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.

Interventions

• 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

Primary outcome measures

• fMRI Neural Response to Food Portion Size Images [Time frame: Baseline]
• PACE (Portion Size Susceptibility, Appetite Awareness, Loss of Control Eating, and Eating Speed) Phenotype Score [Time frame: Baseline and 12-month follow-up]
• Child Adiposity [Time frame: Baseline and 12-month follow-up]
• Family Socioeconomic Status (SES) [Time frame: Baseline]
• PACE Phenotype Score Consistency Over Time [Time frame: Baseline and 12-month follow-up]

Secondary outcome measures (12)

• Parent-reported race and ethnicity [Time frame: Baseline]
• Parent-reported socioeconomic status [Time frame: Baseline]
• Parent-reported educational attainment [Time frame: Baseline]
• Food security status [Time frame: Baseline]
• Rurality of family home [Time frame: Baseline]
• Parent-reported feeding practices [Time frame: Baseline]
• Parent-reported appetitive traits [Time frame: Baseline]
• Child temperament [Time frame: Baseline]
• Parent rating of child Tanner stage [Time frame: Baseline]
• Child sleep patterns (parent-reported) [Time frame: Baseline]
• Executive functioning [Time frame: Baseline]
• Child IQ [Time frame: Baseline]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Metabolic Kitchen and Children's Eating Behavior Lab — State College

Identifiers

NCT: NCT07266506 · STUDY00023903

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗