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临床试验/NCT05456516
NCT05456516已完成不适用

Neurocognitive and Behavioral Factors That Promote Resiliency to Pediatric Obesity

Penn State University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
2
主要终点
Child Body Mass Index

研究概览

简要总结

Children from rural communities are at greater risk for obesity than children from more urban communities. However, some children are resilient to obesity despite greater exposure to obesogenic influences in rural communities (e.g., fewer community-level physical activity or healthy eating resources). Identifying factors that promote this resiliency could inform obesity prevention. Eating habits are learned through reinforcement (e.g., hedonic, familial environment), the process through which environmental food cues become valued and influence behavior. Therefore, understanding individual differences in reinforcement learning is essential to uncovering the causes of obesity. Preclinical models have identified two reinforcement learning phenotypes that may have translational importance for understanding excess consumption in humans: 1) goal-tracking-environmental cues have predictive value; and 2) sign-tracking-environmental cues have predictive and hedonic value (i.e., incentive salience). Sign-tracking is associated with poorer attentional control, greater impulsivity, and lower prefrontal cortex (PFC) engagement in response to reward cues. This parallels neurocognitive deficits observed in pediatric obesity (i.e., worse impulsivity, lower PFC food cue reactivity). The proposed research aims to determine if reinforcement learning phenotype (i.e., sign- and goal-tracking) is 1) associated with adiposity due to its influence on neural food cue reactivity, 2) associated with reward-driven overconsumption and meal intake due to its influence on eating behaviors; and 3) associated with changes in adiposity over 1 year. The investigators hypothesize that goal-tracking will promote resiliency to obesity due to: 1) reduced attribution of incentive salience and greater PFC engagement to food cues; and 2) reduced reward-driven overconsumption. Finally, the investigators hypothesize reinforcement learning phenotype will be associated due to its influence on eating behaviors associated with overconsumption (e.g., larger bites, faster bite rat and eating sped). To test this hypothesis, the investigators will enroll 76, 8-10-year-old children, half with healthy weight and half with obesity based on Centers for Disease Control definitions. Methods will include computer tasks to assess reinforcement learning, dual x-ray absorptiometry to assess adiposity, and neural food cue reactivity from functional near-infrared spectroscopy (fNIRS).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child Inclusion Criteria:
  • In order to be enrolled, children must be of good health based on parental self-report.
  • Have no neurodevelopmental disorder (e.g., attention deficit hyperactivity disorder - ADHD) or learning disabilities (e.g., dyslexia).
  • Have no allergies to the foods or ingredients used in the study.
  • Not be taking any medications known to influence body weight, taste, food intake, behavior, or blood flow.
  • Be 8-10 years-old at enrollment.
  • speaks English.
  • Parent Inclusion Criteria:
  • The parent who has the most knowledge of the child's eating behavior, sleep and behavior must be available to attend the visits with their child. This would be decided among the parents.

排除标准

  • They are not within the age requirements (< than 8 years old or > than 10 years-old at baseline).
  • If they are taking cold or allergy medication, or other medications known to influence cognitive function, taste, appetite, or blood flow.
  • don't speak English.
  • are colorblind.
  • has a learning disability, ADHD, language delays, autism or other neurological or psychological conditions.
  • has a pre-existing medical condition such as type I or type II diabetes, rheumatoid arthritis, Cushing's syndrome, Down's syndrome, severe lactose intolerance, Prader-Willi syndrome, HIV, cancer, renal failure, or cerebral palsy.
  • is allergic to foods or ingredients used in the study.
  • Parent Exclusion Criteria:
  • the parent is unable to attend the study visits

研究组 & 干预措施

All participants

Other

There is only 1 arm in this study

干预措施: Food Rating (Behavioral)

结局指标

主要结局

Child Body Mass Index

时间窗: baseline and 1 year follow-up

child height and weight will be measured

Food Intake in Grams During a Standard Meal

时间窗: baseline and 1-year follow-up

Intake in grams from standard meal

Food Intake in kcal During a Standard Meal

时间窗: baseline and 1-year follow-up

Intake in kcal during a standard meal

Food Intake in Grams During a Snack Buffet When Not Hungry

时间窗: baseline

Intake in grams during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)

Food Intake in kcal During a Snack Buffet When Not Hungry

时间窗: baseline

Intake in kcal during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)

Child body mass index

时间窗: baseline and 1 year follow-up

child height and weight will be measured

Oxy- and deoxyhemoglobin in response to food cues

时间窗: baseline

Functional near infrared spectroscopy (fNIRS) will measure brain activity through oxy- and deoxyhemoglobin in response to images of high and low energy dense foods.

Food intake in grams during a standard meal

时间窗: baseline and 1-year follow-up

Intake in grams from standard meal

Food intake in kcal during a standard meal

时间窗: baseline and 1-year follow-up

Intake in kcal during a standard meal

Video coding of standard meal

时间窗: baseline and 1-year follow-up

A digital recording of the child eating a standard meal will be saved. We have developed a behavior coding protocol to measure child meal microstructure (e.g., bites, bite size, meal duration). We have also validated a computational model to assess cumulative intake curves from video coded bite data.

Food intake in grams during a snack buffet when not hungry

时间窗: baseline

Intake in grams during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)

Food intake in kcal during a snack buffet when not hungry

时间窗: baseline

Intake in kcal during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)

Reward-related decision making during 2-stage reinforcement learning task

时间窗: baseline

The 2-stage reinforcement learning task has a first stage two arm bandit with deterministic stage progression and a second stage one arm bandit. Reward distributions between the two second-stage states gradually drift throughout the task. Half the trials will be 'bonus' trials. Performance will be assessed using a computational model in addition to looking at trial-to-trial decisions.

Value modulated attentional capture

时间窗: baseline

The value-modulated attentional capture task uses two phases - a training phase during which high and low reward conditions are learned and a test phase during which participants complete a task that no longer depends upon the previously learned reward contingencies. During the test phase, stimuli from the training phase are used as distractors. Attentional capture is measured by comparing performance on trials that have distractors previously associated with high reward to those with distractors previously associated with low reward.

Body Composition

时间窗: baseline and 1-year follow-up

The BodPod uses air displacement plethysmography to assess body composition including fat mass and fat-free mass in children

次要结局

  • Oxy- and deoxyhemoglobin in response to rating food health, taste, and wanting(baseline)
  • Oxy- and deoxyhemoglobin in response to food choice(baseline)
  • Eye-tracking during the value-modulated attentional capture task(baseline)
  • Eye-tracking during the food choice task (during functional near infrared spectroscopy)(baseline)
  • Video coding of snack buffet(baseline)
  • Population density(baseline)
  • Child Pavlovian Instrumental Transfer Task(1-year follow-up)
  • Oxy- and deoxyhemoglobin in response to consumption of foods(1-year follow-up)
  • Oxy- and deoxyhemoglobin in response to rating food taste and wanting after consumption(1-year follow-up.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaina Pearce

Assistant Research Professor

Penn State University

研究点 (2)

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