The Pennsylvania State University
University Park, Pennsylvania, 16802, United States
Location status: Recruiting
Location contact
Kathleen L Keller, Ph.D.
PRINCIPAL_INVESTIGATOR
Kyle M Hallisky, B.S.
CONTACT
Terri L Cravener, M.S.
CONTACT
NCT Number: NCT05073185
Strong empirical evidence shows food marketing promotes excess energy intake and obesity. Yet, not all children are susceptible to its effects and this variability is poorly understood. Identifying sources of this variability is a public health priority not only because it may elucidate characteristics of children who are most susceptible, but also because it may highlight novel sources of resiliency to overconsumption. The proposed research will use state-of-the art, data-driven approaches to identify neural, cognitive and behavioral phenotypes associated with resiliency to food-cue (i.e. food advertisement) induced overeating and determine whether these phenotypes protect children from weight gain during the critical pre-adolescent period.
Interested in participating?
Request Info7 year–9 year
All sexes
Observational
University Park, Pennsylvania, 16802, United States
Location status: Recruiting
Kathleen L Keller, Ph.D.
PRINCIPAL_INVESTIGATOR
Kyle M Hallisky, B.S.
CONTACT
Terri L Cravener, M.S.
CONTACT
The investigator's central hypothesis is that children who are resistant to food-cue induced overeating will exhibit a distinct cluster of neural, behavioral, and cognitive traits that protect them from weight gain, even in the context of high-familial obesity risk. Identifying these traits is critical to the development of successful, individually tailored obesity prevention programs. This hypothesis is informed by compelling preliminary research showing that children who are less susceptible to food-cue induced eating in the laboratory show decreased neural activation in somatosensory (i.e., post-central gyrus) and reward (i.e., striatum) regions and increased activation in cognitive control regions (i.e., dorsolateral prefrontal cortex-dlPFC) following food commercial exposure.
These results provide a strong foundation for characterizing neural responses that are associated with resiliency to food-cue induced eating, but highlight major gaps in the literature that must be addressed to advance the field. This proposal will make three novel contributions to the understanding of the etiology of obesity. Using a prospective, family-risk design, the investigators will follow 100, 7-9 year-old children who have healthy weight but vary by risk for obesity (based on maternal weight status) for 1 year to characterize neural and behavioral responses to food commercials and identify common neural networks associated with resiliency to food-cue induced overconsumption. Second, the investigators will use sophisticated behavioral coding to characterize children's eating following food commercial exposure at both homeostatic (i.e., meal consumed when hungry) and non-homeostatic (i.e., eating in the absence of hunger - EAH snack buffet) events and relate individual differences in eating behavior to neural phenotypes. Finally, the investigators will follow children over 1 year to determine whether the neural and behavioral responses at baseline are protective against adiposity gains, during a critical period where children are cognizant of the purpose of advertising, but cannot fully defend against its effects.
Baseline data will be collected over 4 weekly initial visits, followed by a 5th visit one year later.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Child Inclusion Criteria:
Parent Inclusion Criteria:
Exclusion criteria
Children would be excluded if:
Parent Exclusion Criteria:
Time frame: baseline
Whole-brain response to food commercials, followed by images of high and low energy density foods in a fMRI scan
Time frame: baseline
Whole-brain response to toy commercials, followed by images of high and low energy density foods in a fMRI scan
Time frame: baseline
Intake in grams from an eating in the absence of hunger paradigm consumed following advertisement exposure when children are not hungry (i.e., non-homeostatic intake)
Time frame: baseline
Intake in kcals from an eating in the absence of hunger paradigm consumed following advertisement exposure when children are not hungry (i.e., non-homeostatic intake)
Time frame: baseline
Intake in grams from an eating in the absence of hunger paradigm consumed following advertisement exposure when children are not hungry (i.e., non-homeostatic intake)
Time frame: baseline
Intake in kcals from an eating in the absence of hunger paradigm consumed following advertisement exposure when children are not hungry (i.e., non-homeostatic intake)
Time frame: 1 year
Intake in grams from an eating in the absence of hunger paradigm consumed following advertisement exposure when children are not hungry (i.e., non-homeostatic intake)
Time frame: 1 year
Intake in kcals from an eating in the absence of hunger paradigm consumed following advertisement exposure when children are not hungry (i.e., non-homeostatic intake)
Time frame: baseline
Intake in grams from an eating in the absence of hunger paradigm consumed following advertisement exposure when children are not hungry (i.e., non-homeostatic intake)
Time frame: baseline
Intake in kcals from an eating in the absence of hunger paradigm consumed following advertisement exposure when children are not hungry (i.e., non-homeostatic intake)
Time frame: baseline
A digital recording of the Child eating the Test Meal and the EAH snack buffet will be saved. We have developed a behavior coding technique to count specific behaviors while the child eats. We will also be transcribing the audio.
Time frame: 1 year
A digital recording of the Child eating the Test Meal and the EAH snack buffet will be saved. We have developed a behavior coding technique to count specific behaviors while the child eats. We will also be transcribing the audio.
Time frame: baseline
Examine change in children's fat mass index = total fat mass(kg) / height (m2)
Time frame: baseline
We will examine the strength of the neural connections between reward/somatosensory and cognitive control regions.
Time frame: baseline
We will examine the strength of the neural connections between reward/somatosensory and cognitive control regions.
Time frame: Baseline and 1 year
Android fat mass (%) = (Android fat mass (kg) / total fat mass (kg))*100
Time frame: Baseline and 1 year
Gynoid fat mass (%) = (Gynoid fat mass (kg) / total fat mass (kg))*100
Time frame: Baseline and 1 year
Child questionnaire quantifying the number of hours per day a child is exposed to different types of media.
Time frame: Baseline and 1 year
Child's brand awareness assessed by a child computerized task. Children are asked to match pictures of products and brand logos. No scaling is used.
Time frame: Baseline and 1 year
The Flanker is a measure of executive function, specifically tapping inhibitory control and attention. 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.
Time frame: Baseline and 1 year
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.
Time frame: Baseline and 1 year
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.
Time frame: Baseline
Height (cm) will be measured. Body mass index (BMI) and BMI z scores will be calculated.
Time frame: Baseline
Weight (kg) will be measured. Body mass index (BMI) and BMI z scores will be calculated.
Time frame: 1 year
Height (cm) will be measured. Body mass index (BMI) and BMI z scores will be calculated.
Time frame: 1 year
Weight (kg) will be measured. Body mass index (BMI) and BMI z scores will be calculated.
Time frame: Baseline
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).
Time frame: 1 Year
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).
Time frame: Baseline
The child will be given an IQ test (Wechsler Abbreviated Scale of Intelligence) to determine cognitive ability measures. It is a battery of two subtests: Vocabulary (31-item) and Matrix Reasoning (30-item). Each of the 2 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.
Time frame: 1 year
The child will be given an IQ test (Wechsler Abbreviated Scale of Intelligence) to determine cognitive ability measures. The WASI is a battery of two subtests: Vocabulary (31-item) and Matrix Reasoning (30-item). Each of the 2 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.
Time frame: Baseline
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. They will be asked to make a total of 2 ratings using this scale, one immediately before each meal, and one following the meal.
Time frame: 1 year
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. They will be asked to make a total of 2 ratings using this scale, one immediately before each meal, and one following the meal.
Time frame: Baseline
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.
Time frame: Baseline
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).
Time frame: Baseline
The stop signal task (SST) is used to capture individual differences in response inhibition. There is no max/min range for performance. For both the Stop-signal reaction time and the stop-signal delay: lower values indicate better control. This is administered in the fMRI scanner.
Time frame: Baseline
Parent reported questionnaires of television and internet use and exposure to shows and commercials
Time frame: 1 year
Parent reported questionnaires of television and internet use and exposure to shows and commercials
Time frame: Baseline
Parental questionnaire:Child Puberty and Tanner Questionnaire. Scoring: 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.
Time frame: 1 year
Parental questionnaire:Child Puberty and Tanner Questionnaire. Scoring: 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.
Time frame: Baseline
Parental questionnaire: Child Feeding Questionnaire (CFQ). Scored on a scale of 1-5 with lower values being better (score is the average of items for each subscale).
Time frame: Baseline
Parental questionnaire: The Child Eating Behaviour 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.
Time frame: 1 Year
Parent Questionnaire: Parental 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.
Time frame: Baseline
Behavioral Avoidance/Inhibition Scale Questionnaire. The BIS/BAS Scale is a self-report questionnaire designed to measure two motivational systems: the behavioral inhibition system (BIS), which corresponds to motivation to avoid aversive outcomes, and the behavioral activation system (BAS), which corresponds to motivation to approach goal-oriented outcomes. Participants respond to questions using a 4-point Likert scale. The scale has four subscales; BAS Drive, BAS Fun Seeking, BAS Reward Responsiveness and BIS. Higher values suggest more drive, increased fun seeking, responsiveness to reward, and avoidance of unpleasantness.
Time frame: Baseline
Parental 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.
Time frame: 1 Year
Parental 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.
Time frame: Baseline
Parental questionnaire; Children's Leisure Activities Study Scale (CLASS). This questionnaire asks how much time the child spends in numerous types of physical activity. It is a count of time spent, not a scale.
Time frame: 1 Year
Parental questionnaire; Children's Leisure Activities Study Scale (CLASS). This questionnaire asks how much time the child spends in numerous types of physical activity. It is a count of time spent, not a scale.
Time frame: Baseline
Parental questionnaire: Child sleep 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.
Time frame: 1 Year
Parental questionnaire: Child sleep 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.
Time frame: Baseline
Parental questionnaire: External Food Cue Responsiveness Scale Questionnaire. Nine questions are asked related to external food cues, answered in a 1 (never) -5 (always) scale. Higher scores indicate an increased responsiveness to external food cues.
Time frame: Baseline
Parent questionnaire:Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed to assess alcohol consumption, drinking behaviors, and alcohol-related problems. A score of 0 (nondrinker) to 40 is possible. A score of 8 or more indicates a strong likelihood of hazardous or harmful alcohol consumption.
Time frame: 1 year
Parent questionnaire: Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed to assess alcohol consumption, drinking behaviors, and alcohol-related problems. A score of 0 (nondrinker) to 40 is possible. A score of 8 or more indicates a strong likelihood of hazardous or harmful alcohol consumption.
Time frame: Baseline
Parent questionnaire: 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.
Time frame: Baseline
Parent questionnaire: Household Food Security Survey Module (HFFSM). Households are classified into food security status categories (1) food secure (fewer than 3 food-insecure responses); (2) low food security (more than 2 but fewer than 8 food-insecure responses among households with children); and (3) very low food security (8 or more food-insecure responses among the 18 questions for households with children) based on the number of food-insecure responses to questions. The scales differ on each question, but higher overall scores correspond with greater food insecurity. Families are said to be food insecure if they fall in categories 2 or 3.
Time frame: Baseline
Parent questionnaire: Household Food Insecurity Access Scale (HFIAS). The HFIAS consists of two types of related questions. The first question type is called an occurrence question. There are nine occurrence questions that ask whether a specific condition associated with the experience of food insecurity ever occurred during the previous four weeks (30 days). Each severity question is followed by a frequency-of-occurrence question, which asks how often a reported condition occurred during the previous four weeks (1 = rarely, 2 = sometimes, 3 = often). Scoring ranges from 0-27, with higher scores indicating more food insecurity.
Time frame: Baseline
Parent questionnaire: Community Childhood Hunger ID Project (CCHIP) is regarded as a model for measuring hunger in low-income families. A series of 8 questions are asked about child hunger in light of available resources, with yes or no as possible answers. Children are classified into one of 3 categories. A child is "not hungry" with a score of 0 affirmatives, "at risk" with 1-4 and "hungry" with 5 or more.
Time frame: Baseline
Parental questionnaire assessing the types of food kept in the home food inventory
Time frame: Baseline
Parent questionnaire: information describing the cultural, social and financial characteristics of the family.
Time frame: 1 Year
Parent questionnaire: information describing the cultural, social and financial characteristics of the family.
Time frame: Baseline
The Behavioral Choice Task (Relative Reinforcing Value Task) is a computer task developed for use of reinforcement paradigms in humans. It has the ability to measure reinforcing value of food and toys through the use of flexible reinforcement schedules.
Time frame: Baseline
Modified version of a decision-making task developed by Kool et al. (2017), which examine model-based decision making via the manipulation of high and low stake rewards.
Time frame: Baseline
Child questionnaire: alternative design to the Big Five Model, used to measure personality traits using images. There are 15 items (3 items from each scale: extraversion, neuroticism, openness, agreeableness, and conscientiousness), which are answered on a 3-point scale.
Time frame: Baseline
Child questionnaire: 21 item questionnaire developed to assess stress (physical and emotional) in children. The questions are answered using a 4-point Likert scale (1=never, 4 = very often).
Time frame: Baseline
Child questionnaire: the questionnaire assesses whether someone experienced a subjective episode of loss of control eating in the past three months. If answered "Yes", participants are instructed to respond to additional questions on before, during and after the loss of control eating occurred. No scaling is used.
Time frame: Baseline
Parent questionnaire: The Perceived Stress Scale (PSS) is used to understand how different situations affect our perceived stress. The questions ask about feelings and thoughts over the past 3 months. Questions are answered using 5 points (0 = never, 4 = very often) Likert scale. 4 questions are reversed scored (0 = 4, 4 = 0). Scores from 0-13 indicate low stress, 14-26 indicate moderate stress, 27-40 indicate high stress.
Time frame: Baseline
Parent questionnaire: Confusion, Hubbub and Order Scale (CHAOS) is a 15 question survey describing the home environment. Questions are answered using 4 points (1 = Very much like your own home, 4 = Non at all like your own home). Final scores are summed across the 15 items.
Time frame: Baseline
Parent questionnaire: The Lifestyle Behavior Checklist is a 25 item, two-scale questionnaire. It is used to identify parental perception of problematic behaviors in the context of overweight and obesity (Problem Scale). The questionnaire also assesses the ability of the parent to deal with problematic behaviors (Confidence Scale). Each question on the Problem Scale is scored from 1 (not at all) to 7 (very much). Each question on the Confidence Scale is scored from 1 (Certain I can't do it) to 10 (Certain I can do i).
Time frame: Baseline
Parent questionnaire: The Binge Eating Scale (BES) is a 16-item questionnaire used to identify certain binge eating behaviors. < 17 indicates non-binging, 18-26 indicates moderate binging, and >27 indicates severe binging.
Time frame: Baseline
Parent questionnaire: The Family Food Behavior Survey (FFBS) is a 20-item questionnaire that examines the degree to which adult monitor and make decisions about their child's eating behavior. Each of the 20 questions is scored using a 5 point Likert scale (0 = never true, 4 = always true). Their are four scales, (1). Maternal control of child feeding, (2). Maternal presence, (3). Child choice, (4). Organization. Higher scores on any scale indicate greater involvement by child or mother.
Time frame: Baseline
Parent questionnare: The Sensitivity to Punishment and Reward Questionnaire (SPSRQ) consists of 48 questions. Parents respond with "Yes" or "No" and it is scored on two scales. One scale is for sensitivity to punishment, and one scale is for sensitivity to reward. The items are summed to make a final score for each subscale.
Time frame: Baseline
Parent questionnaire: 24 item questionnaire assessing weight loss strategies over the last two years. Items are measured on a 5-point scale from 1 = Never, 5 = Always. There are 11 items relating to healthy weight loss factors and 9 items related to unhealthy weight loss factors.
Time frame: Baseline
Parent Questionnaire: The Three Factor Eating Questionnaire - Revised 18 items - is an 18-item questionnaire assessing feelings and experiences towards eating behaviors. It is scored on three sub-scales: uncontrolled eating, cognitive restraint and emotional eating. Any items answered 1-2 are scored 1; 3-4 are scored as 2; 5-6 scored as 3, and 7-8 are scored as 4.
Time frame: Baseline
Parent Questionnaire: The Parental Strategies to Teach about Advertising is a questionnaire assessing parental attitudes, beliefs and behaviors towards media and advertising use. There is no scaling used.
Time frame: Baseline
Parent Questionnaire: The Structure and Control in Parent Feeding (SCPF) questionnaire assesses positive aspects of parental feeding practices. The Structure Model consists of 22 questions and the Control Model consists of 12 questions. The items are answered using a 5 points scale 0 = Never, 4 = Always.
Time frame: Baseline
Parent Questionnaire: The Comprehensive Feeding Practices Questionnaire is a 49-item, 12 factor survey. The factors include Monitoring, Emotional Regulation, Food as Reward. Child Control, Modeling, Restriction for Weight, Restriction for Health, Teaching Nutrition, Encourage Balance, Pressure to Eat, Healthy Environment and Involvement.
Time frame: 1 Year
Parent Questionnaire: The Comprehensive Feeding Practices Questionnaire is a 49-item, 12 factor survey. The factors include Monitoring, Emotional Regulation, Food as Reward. Child Control, Modeling, Restriction for Weight, Restriction for Health, Teaching Nutrition, Encourage Balance, Pressure to Eat, Healthy Environment and Involvement.
Contact information is provided by the study sponsor or research team.
Kyle M Hallisky, B.S.
CONTACT
Terri L Cravener, MS
CONTACT
Penn State University
Other
Characterizing Resilience to Food-cue Induced Overeating in Children
Acronym: REACH
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