Development of an Eating Behavior Risk Score

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

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

Идентификаторы

NCT: NCT07266506 · STUDY00023903

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗