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ObesityPACENCT07266506

Development of an Eating Behavior Risk Score

A study testing Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological Measures in people with Obesity and Childhood, run by Penn State University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 7 to 9 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood
What is being tested?
Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological Measures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
1 siteUnited States
Study dates
1 Jul 2026to 30 Jun 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kathleen L Keller, Ph.D. contact

814-863-2915

klk37@psu.edu

United States1 site
  • Metabolic Kitchen and Children's Eating Behavior Lab

    State College, Pennsylvania, 16802

    Kathleen L Keller, Ph.D

Other trials in United States

About this study

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.

Read the 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.

Conditions
Obesity, Childhood
Being tested
Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological Measures
Keywords
Obesity, Eating Behaviors, Appetite Regulation, Functional magnetic resonance imaging, Food-cue reactivity
Medical subject headings
Obesity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological MeasuresBehavioural

    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.

Study groups in NCT07266506
Study groupRoleWhat they receive
Children in PACE Phenotype StudyExperimentalA 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.
Receives: Behavioral: Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological Measures

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline and 12-month follow-up

Secondary outcomes (25)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline

  5. Rurality of family home

    Determined by family home zip code to classify rural versus urban residency, assessing environmental influences on child health and behavior.

    Measured: Baseline

  6. Parent-reported feeding practices

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

    Measured: Baseline

  7. Parent-reported appetitive traits

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

    Measured: Baseline

  8. Child temperament

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

    Measured: Baseline

  9. 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.

    Measured: Baseline

  10. Child sleep patterns (parent-reported)

    Parent-reported child sleep duration and quality via standardized sleep questionnaires to evaluate potential effects on weight and behavior.

    Measured: Baseline

  11. Executive functioning

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

    Measured: Baseline

  12. Child IQ

    Standardized assessment of child intelligence quotient using WASI-II.

    Measured: Baseline

  13. Food liking and wanting during laboratory meals

    Child's hedonic ratings of food items consumed during laboratory meals to assess preferences influencing intake.

    Measured: Through study completion, an average of 1 year

  14. 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.

    Measured: Through study completion, an average of 1 year

  15. 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.

    Measured: Through study completion, an average of 1 year

  16. 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.

    Measured: Baseline

  17. Child interoceptive awareness questionnaire

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

    Measured: Baseline

  18. Physical activity by accelerometry and questionnaire

    Objective measurement of physical activity through accelerometer devices combined with parent and child questionnaires to quantify movement levels.

    Measured: Baseline

  19. Sleep duration assessed by accelerometry

    Sleep duration in hours per night

    Measured: Baseline

  20. 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.

    Measured: Baseline

  21. 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.

    Measured: Baseline

  22. Relative reinforcing value of food assessed on computer task

    Behavioral task evaluating the motivational value of food compared to alternative rewards, indicating reward sensitivity.

    Measured: Baseline

  23. 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.

    Measured: Baseline

  24. Sleep Efficiency Percentage

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

    Measured: Baseline

  25. Wake after sleep onset (WASO)

    Minutes awake after onset of sleep.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion30 Jun 2031 (estimated)
  4. Study completion30 Jun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07266506
Sponsor's protocol ID
STUDY00023903
Acronym
PACE
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Assessment of PACE Eating Phenotype and Related Behavioral and Neurobiological Measures in people with Obesity and Childhood, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kathleen L Keller, Ph.D. (814-863-2915, klk37@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fMRI Neural Response to Food Portion Size Images (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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Development of an Eating Behavior Risk Score | AzTrials