Development of an Eating Behavior Risk Score

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-9
SponsorPenn State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

420 Participants
are divided into 1 treatment group
Group A: Children in PACE Phenotype StudyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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