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OpenTrials
Completed

NCT Number: NCT05456516

Study of Brain, Reward, and Kids' Eating

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).

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Key information

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chandlee Laboratory

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • 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

Treatment and study plan

Food Rating

Behavioral

Children will rate foods on taste, health, and desire to eat. The order in which they rate the food characteristics is randomly assigned and counter-balanced across participants

Primary outcomes

  1. Child Body Mass Index

    Time frame: baseline and 1 year follow-up

    child height and weight will be measured

  2. Body Composition

    Time frame: 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

  3. Food Intake in Grams During a Standard Meal

    Time frame: baseline and 1-year follow-up

    Intake in grams from standard meal

  4. Food Intake in kcal During a Standard Meal

    Time frame: baseline and 1-year follow-up

    Intake in kcal during a standard meal

  5. Food Intake in Grams During a Snack Buffet When Not Hungry

    Time frame: baseline

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

  6. Food Intake in kcal During a Snack Buffet When Not Hungry

    Time frame: baseline

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

Other outcomes

  1. Oxy- and Deoxyhemoglobin in Response to Rating Food Health, Taste, and Wanting

    Time frame: baseline

    Functional near infrared spectroscopy will measure brain activity through oxy- and deoxyhemoglobin while children rate food images on health, taste and wanting

  2. Oxy- and Deoxyhemoglobin in Response to Food Choice

    Time frame: baseline

    Functional near infrared spectroscopy will measure brain activity through oxy- and deoxyhemoglobin while children choose which of two foods they would like to eat

  3. Oxy- and Deoxyhemoglobin in Response to Consumption of Foods

    Time frame: 1-year follow-up

    Functional near infrared spectroscopy (fNIRS) will measure brain activity through oxy- and deoxyhemoglobin in response to consumption of taste-test samples of foods both before and after a standard laboratory meal

  4. Oxy- and Deoxyhemoglobin in Response to Rating Food Taste and Wanting After Consumption

    Time frame: 1-year follow-up.

    Functional near infrared spectroscopy will measure brain activity through oxy- and deoxyhemoglobin while children rate how much they want foods samples and how each sample tasted after consumption. This is completed before and after a standard test meal

  5. Taste Testing to Measure Liking of Foods

    Time frame: baseline and 1-year follow-up

    Ratings of how much a child likes a food is measured on a computerized visual scale. The scale is from 1 (Hate It) to 5 (Love It).

  6. Child Fullness

    Time frame: baseline and 1-year follow-up

    Child fullness will be measured using a pictorial fullness scale termed a Freddy Fullness scale. Prior to the visit, children will be instructed to fast for at least 3hrs. They are then instructed on use of the scale by trained research personnel. Following this, children will be asked to report current fullness on the scale, which measures a fullness range of 0 to 150 mm. This will be done before and after each meal and taste test. The scale will also be used before and after the fNIRS session.

  7. Physical Activity

    Time frame: baseline and 1-year follow-up

    An ActiGraph watch will be given to the parent with instruction. The child will be wearing the wrist watch for one week in the baseline time period (other than when showering, bathing or in a pool) and will hand it back at their next visit.

  8. Sleep Efficiency

    Time frame: baseline and 1-year follow-up

    An ActiGraph watch will be given to the parent with instruction. The child will be wearing the wrist watch for one week in the baseline time period (other than when showering, bathing or in a pool).

  9. Children's Anxiety Meter Scale

    Time frame: baseline and 1-year follow-up

    Self-report questionnaire for child: The Children's Anxiety Meter Scale measures state anxiety before and after the fNRIS session

  10. Perceived Stress Scale

    Time frame: baseline

    Self-report questionnaire for child: The Perceived Stress Scale asks the child about feelings over the last month to assess perceived stress

  11. Loss of Control Eating Questionnaire

    Time frame: baseline and 1-year follow-up

    Self-report questionnaire for child: The loss of control eating questionnaire asks children if they have recently experienced and episode of loss of control eating

  12. Demographics

    Time frame: baseline and 1-year follow-up

    Parental report questionnaire: information describing the cultural, social and financial characteristics of the family.

  13. Child Pubertal Development Assessment

    Time frame: baseline and 1-year follow-up

    Parental report questionnaire: Child Puberty and Tanner Questionnaire is score in the following way: Male genitals are scored on a scale of 1 to 5 maturity, female breasts on a scale of 1 to 5 and both males and females on a scale of 1 to 5 for pubic hair quality and extension. Higher values indicate more pubertal development

  14. Child Feeding Questionnaire

    Time frame: baseline and 1-year follow-up

    Parental report questionnaire: Child Feeding Questionnaire (CFQ) is scored on a scale of 1-5 with lower values being better (score is the average of items for each subscale).

  15. Child Eating Behavior Questionnaire

    Time frame: baseline

    Parental report questionnaire: The Child Eating Behavior Questionnaire (CEBQ) was designed to assess children's eating scale styles. It is a parent-report measure comprised of 35 items, each rated on a five-point likert scale that ranges from never to always. It is made up of eight scales: Food responsiveness, Emotional over-eating, Enjoyment of food, Desire to drink, Satiety responsiveness, Slowness in eating, Emotional under-eating, and Food fussiness.

  16. Children's Behavior Questionnaire

    Time frame: baseline

    Parental report questionnaire: The Child Behavior questionnaire (CBQ) is an assessment of temperament.Children are assessed on 15 primary temperament characteristics using a 7 point Likert scale.

  17. Behavior Rating Inventory of Executive Function - 2

    Time frame: baseline

    Parental report report questionnaire: The Behavior Rating Inventory of Executive Function (BRIEF-2) assesses executive function and self-regulation. Questions are answered on a 3-point scale (never, sometimes, often). This rating is scored by taking a sum of all items and referencing and age- and sex-normalized tables to get T-scores and percentiles; Higher T-scores indicate less Executive Function.

  18. Binge Eating Scale

    Time frame: baseline and 1-year follow-up

    Parental report questionnaire: The Binge Eating Scale asks parents about children's eating behaviors related to binge eating and overeating. Response are from 1 - 4 which scales from the least to most severe

  19. Child Sleep Habits Questionnaire

    Time frame: baseline and 1-year follow-up

    Parental report questionnaire: The Child Sleep Habits Questionnaire contains 8 questions describing a child's sleep habits. The answers are on a 3 point scale with an opportunity to note if the answer indicates a problem.

  20. External Food Cues Responsiveness Scale

    Time frame: baseline and 1-year follow-up

    Parental report questionnaire: The External Food Cue Responsiveness Scale Questionnaire asks nine questions related to external food cues, answered in a 1 (never) -5 (always) scale. Higher scores indicate an increased responsiveness to external food cues.

  21. Family Food Behavior Survey

    Time frame: baseline

    Parental report questionnaire: The Family Food Behavior Survey asks parents about the food and feeding behaviors in the home and has the following sub scales: and provides subscale scores for the following behaviors: Maternal Control, Maternal Presences, Child Choice, and Organization. Questions are scored from 0 - Never True, 1 - Rarely True, 2 - Sometimes, 3 - Often True, 4 - Always True

  22. Sensitivity to Punishment and Reward Questionnaire

    Time frame: baseline

    Parental report questionnaire: The Sensitivity to Punishment and Reward Questionnaire asks about child behaviors and has the follow sub scales: Fear/Shyness, Anxiety, Conflict Avoidance, Sensory Reward, Drive, Responsiveness to Social Approval, Impulsivity/Fun Seeking. The original 4 subscales (2004; 34 item subscales): Sensitivity to Punishment, Impulsivity/Fun Seeking, Drive, and Reward Responsiveness. Parents respond from 1 - Strongly Disagree, 2 - Disagree, 3 - Neither Agree nor Disagree, 4 - Agree, 5 - Strongly Agree

  23. Three Factor Eating Questionnaire

    Time frame: baseline

    Self-report questionnaire for the parent: The Three Factor Eating Questionnaire asks the parents about their own eating behaviors and has the following subscales - Cognitive Control of Eating Behaviors, Disinhibition of Control, and Susceptibility to Hunger.

  24. Parent Weight Loss Behavior Questionnaire

    Time frame: baseline and 1-year follow-up

    Self-report questionnaire for the parent: The Parent Weight Loss Behavior Questionnaire asks parents about their use of healthy and unhealthy weight loss behaviors

  25. IQ Estimation

    Time frame: baseline

    The child will be given the Wechsler Abbreviated Scale of Intelligence to estimate cognitive ability. It is a battery of four subtests: Vocabulary (31-item), Block Design (13-item), Similarities (24-item) and Matrix Reasoning (30-item). Each of the 4 subtests is scored by taking a sum of all items and referencing and age- and sex- normed tables to get standardized scores; these standardized scores are then added to get the 3 subscale scores, their associated IQ scores percentiles; Higher scores indicate a higher IQ.

  26. Processing Speed and Flexibility

    Time frame: baseline

    The Dellis-Kaplan Executive Function System Trail Making Test, Design Fluency, and Verbal Fluency will be used to assess motor processing speed, cognitive processing speed, fluency, and switching

  27. NIH Toolbox - Flanker Test

    Time frame: baseline

    The Flanker is a measure of interference. Scoring is based on a combination of accuracy and reaction time. A 2-vector scoring method is employed that uses accuracy and reaction time, where each of these "vectors" ranges in value between 0 and 5, and the computed score, combining each vector score, ranges in value from 0-10. For any given individual, accuracy is considered first. If accuracy levels for the participant are less than or equal to 80%, the final "total" computed score is equal to the accuracy score. If accuracy levels for the participant reach more than 80%, the reaction time score and accuracy score are combined. Higher scores indicate higher levels of ability to attend to relevant stimuli and inhibit attention from irrelevant stimuli.

  28. NIH Toolbox - List Sorting Test

    Time frame: baseline

    The List Sorting Working memory test assesses working memory. The List Sorting test requires immediate recall and sequencing of different visually and orally presented stimuli (i.e., "working memory"). Pictures of different foods and animals are displayed with accompanying audio recording and written text (e.g., "elephant"), and the participant is asked to say the items back in size order from smallest to largest, first within a single dimension (either animals or foods, called 1-List) and then on two dimensions (foods, then animals, called 2-List). The test takes approximately seven minutes to administer. List Sorting is scored by summing the total number of items correctly recalled and sequenced on 1-List and 2-List, which can range from 0-26.Higher scores on each of these indicate higher levels of working memory within the normative standard being applied.

  29. NIH Toolbox - Dimensional Card Sorting Test

    Time frame: baseline

    The Dimensional Change Card Sort Test is used to measure cognitive flexibility. Two target pictures are presented that vary along two dimensions (e.g., shape and color). Scoring is based on a combination of accuracy and reaction time. A 2-vector scoring method is employed that uses accuracy and reaction time, scores ranging from 0-10. For any given individual, accuracy is considered first. If accuracy levels for the participant are less than or equal to 80%, the final "total" computed score is equal to the accuracy score. If accuracy levels for the participant reach more than 80%, the reaction time score and accuracy score are combined. Higher scores indicate higher levels of cognitive flexibility.

  30. Child Adiposity

    Time frame: baseline and 1-year follow-up

    An air displacement plethysmograph (BodPod) will be used to measure child body composition

  31. Parent Body Mass Index

    Time frame: baseline and 1-year follow-up

    The parent who primarily makes food related decisions in the house will accompany the child to the visit and will have their height and weight measured. They will also report on the height and weight of the other parent

  32. Home Food Inventory

    Time frame: baseline and 1-year follow-up

    Parental report questionnaire: The Home Food Inventory is a pre-specified list of foods that parents mark as present or not in the home. This is completed by the parent while at home.

  33. Food Frequency Questionnaire

    Time frame: baseline and 1-year follow-up

    Parental report questionnaire: The HELIX study short, quantitative food frequency questionnaire asks parents to report the frequency with which their child consumes various foods.

  34. Home Food Environment

    Time frame: baseline and 1-year follow-up

    Parental report questionnaire: Parents report on various aspect of the home and neighborhood environment

  35. Structure and Control in Parent Feeding

    Time frame: baseline

    Parental report questionnaire: The Structure and Control in Parent Feeding is an assessment of parental feeding practices

  36. Feeding to Manage Child Behavior Questionnaire

    Time frame: baseline

    Parental report questionnaire: the Feeding to Manage Child Behavior Questionnaire is an assessment of parental use of food to manage or control their child's behaviors

  37. Body Image Scale

    Time frame: 1-year follow-up

    Child report questionnaire: The Body Image Scale assesses children's own perception of their body size and their ideal body size

  38. Weight Concerns Scale

    Time frame: 1-year follow-up

    Child report questionnaire: The Weight Concerns Scale assesses the extent to which children are concerned about their weight

  39. Stress in Children Questionnaire

    Time frame: baseline and 1-year follow-up

    Child report questionnaire: The Stress in Children Questionnaire assesses child stress

  40. Lifestyle Behavior Checklist

    Time frame: baseline

    Parental report questionnaire: The Lifestyle Behavior Checklist is a list of problematic food- and eating-related behaviors that parents rate the frequency of and indicate if they consider it problematic

  41. Dietary Metabolites (Urine)

    Time frame: baseline and 1-year follow-up

    Metabolites from first-void child urine samples

  42. Video Coding of Meals

    Time frame: baseline and followup

    Children will be video recorded and eating behaviors will be coded including bites, meal duration, latency to first bite, and distraction behaviors. Other microstructure behaviors will be computed such as bite size and eating rate.

  43. Video Coding of Snack Buffet

    Time frame: baseline

    Children will be video recorded and eating behaviors will be coded including bites, meal duration, latency to first bite, and distraction behaviors. Other microstructure behaviors will be computed such as bite size and eating rate. Additionally, approach and self-control behaviors will be codes from videos (e.g., smelling food, distraction from food).

  44. Space Game Task

    Time frame: Baseline

    This is a two-stage reward-related decision making tasks that will be assessed with a computational model of reinforcement learning that estimates parameters such as weighting, reward decay, choice and response 'stickiness' and tendency to switch.

  45. Value Modulated Attentional Capture

    Time frame: baseline

    This is a visual attention task that measures response speed when there is a presence of a rewarded or non-rewarded visual distraction. Key outcome is response speed difference between trials with rewarded visual cue versus not.

  46. Pavlovian Instrumental Transfer Task

    Time frame: followup

    The pavlovian instrumental transfer task for children measures extent to which stimuli previously associated with reward (or other outcomes) enhance or bias independently learned goal-directed actions. Outcomes will assess general and specific PIT scores

  47. Population Density

    Time frame: baseline and followup

    The population density of primary home address and school address will be assessed using the National Center for Education Statistics locale definitions.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Neurocognitive and Behavioral Factors That Promote Resiliency to Pediatric Obesity

Acronym: BRAKE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2022
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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