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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002015 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Other | There is only 1 arm in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Child Body Mass Index | child height and weight will be measured | baseline and 1 year follow-up |
| Body Composition | The BodPod uses air displacement plethysmography to assess body composition including fat mass and fat-free mass in children | baseline and 1-year follow-up |
| Food Intake in Grams During a Standard Meal | Intake in grams from standard meal | baseline and 1-year follow-up |
| Food Intake in kcal During a Standard Meal | Intake in kcal during a standard meal | baseline and 1-year follow-up |
| Food Intake in Grams During a Snack Buffet When Not Hungry | Intake in grams during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake) | baseline |
| Food Intake in kcal During a Snack Buffet When Not Hungry | Intake in kcal during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake) | baseline |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxy- and Deoxyhemoglobin in Response to Rating Food Health, Taste, and Wanting | Functional near infrared spectroscopy will measure brain activity through oxy- and deoxyhemoglobin while children rate food images on health, taste and wanting | baseline |
| Oxy- and Deoxyhemoglobin in Response to Food Choice |
Child Inclusion Criteria:
Parent Inclusion Criteria:
Exclusion Criteria:
Parent Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandlee Laboratory | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32505786 | Background | Pearce AL, Adise S, Roberts NJ, White C, Geier CF, Keller KL. Individual differences in the influence of taste and health impact successful dietary self-control: A mouse tracking food choice study in children. Physiol Behav. 2020 Sep 1;223:112990. doi: 10.1016/j.physbeh.2020.112990. Epub 2020 Jun 4. | |
| 34662600 | Background | Pearce AL, Cevallos MC, Romano O, Daoud E, Keller KL. Child meal microstructure and eating behaviors: A systematic review. Appetite. 2022 Jan 1;168:105752. doi: 10.1016/j.appet.2021.105752. Epub 2021 Oct 16. |
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All protocols, methods, and data obtained from this project will be made publicly available following the National Institutes of Health's FAIR principles on Open Science Framework or other sites for data sharing. The final dataset will be published with a persistent identifier to ensure that the dataset will be Findable even if the hosting platforms change. Rich meta-data will be published to ensure the data are Accessible. Where possible, meta-data will use formal and searchable language and terms based on common ontologies so that the data are Interoperable. In order to ensure Reusability, meta-data will include detailed information about the protocols and methods following scientific community standards. Data intended for broader use will be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of individual subjects.
The data will be available within 6 mo of completion of data collection
No access criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | This is a single arm study - all participants completed the same protocols. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 1 year followup |
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Difference at 1-year follow-up reflects loss to follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This is a single arm study - all participants completed the same protocols. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Child Body Mass Index | child height and weight will be measured | Posted | Mean | Standard Deviation | kg/m-squred | baseline and 1 year follow-up |
|
|
from enrollment until end of follow-up, up to 1.5 years
This was a minimal risk study with no intervention beyond the random assignment of behavioral task condition orders in healthy children.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Baseline | baseline data collection | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alaina Pearce | Pennsylvania State University | 3206305713 | azp271@psu.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2024 | Mar 23, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Functional near infrared spectroscopy will measure brain activity through oxy- and deoxyhemoglobin while children choose which of two foods they would like to eat |
| baseline |
| Oxy- and Deoxyhemoglobin in Response to Consumption of Foods | 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 | 1-year follow-up |
| Oxy- and Deoxyhemoglobin in Response to Rating Food Taste and Wanting After Consumption | 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 | 1-year follow-up. |
| Taste Testing to Measure Liking of Foods | 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). | baseline and 1-year follow-up |
| Child Fullness | 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. | baseline and 1-year follow-up |
| Physical Activity | 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. | baseline and 1-year follow-up |
| Sleep Efficiency | 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). | baseline and 1-year follow-up |
| Children's Anxiety Meter Scale | Self-report questionnaire for child: The Children's Anxiety Meter Scale measures state anxiety before and after the fNRIS session | baseline and 1-year follow-up |
| Perceived Stress Scale | Self-report questionnaire for child: The Perceived Stress Scale asks the child about feelings over the last month to assess perceived stress | baseline |
| Loss of Control Eating Questionnaire | 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 | baseline and 1-year follow-up |
| Demographics | Parental report questionnaire: information describing the cultural, social and financial characteristics of the family. | baseline and 1-year follow-up |
| Child Pubertal Development Assessment | 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 | baseline and 1-year follow-up |
| Child Feeding Questionnaire | 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). | baseline and 1-year follow-up |
| Child Eating Behavior Questionnaire | 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. | baseline |
| Children's Behavior Questionnaire | 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. | baseline |
| Behavior Rating Inventory of Executive Function - 2 | 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. | baseline |
| Binge Eating Scale | 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 | baseline and 1-year follow-up |
| Child Sleep Habits Questionnaire | 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. | baseline and 1-year follow-up |
| External Food Cues Responsiveness Scale | 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. | baseline and 1-year follow-up |
| Family Food Behavior Survey | 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 | baseline |
| Sensitivity to Punishment and Reward Questionnaire | 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 | baseline |
| Three Factor Eating Questionnaire | 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. | baseline |
| Parent Weight Loss Behavior Questionnaire | Self-report questionnaire for the parent: The Parent Weight Loss Behavior Questionnaire asks parents about their use of healthy and unhealthy weight loss behaviors | baseline and 1-year follow-up |
| IQ Estimation | 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. | baseline |
| Processing Speed and Flexibility | 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 | baseline |
| NIH Toolbox - Flanker Test | 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. | baseline |
| NIH Toolbox - List Sorting Test | 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. | baseline |
| NIH Toolbox - Dimensional Card Sorting Test | 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. | baseline |
| Child Adiposity | An air displacement plethysmograph (BodPod) will be used to measure child body composition | baseline and 1-year follow-up |
| Parent Body Mass Index | 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 | baseline and 1-year follow-up |
| Home Food Inventory | 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. | baseline and 1-year follow-up |
| Food Frequency Questionnaire | Parental report questionnaire: The HELIX study short, quantitative food frequency questionnaire asks parents to report the frequency with which their child consumes various foods. | baseline and 1-year follow-up |
| Home Food Environment | Parental report questionnaire: Parents report on various aspect of the home and neighborhood environment | baseline and 1-year follow-up |
| Structure and Control in Parent Feeding | Parental report questionnaire: The Structure and Control in Parent Feeding is an assessment of parental feeding practices | baseline |
| Feeding to Manage Child Behavior Questionnaire | 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 | baseline |
| Body Image Scale | Child report questionnaire: The Body Image Scale assesses children's own perception of their body size and their ideal body size | 1-year follow-up |
| Weight Concerns Scale | Child report questionnaire: The Weight Concerns Scale assesses the extent to which children are concerned about their weight | 1-year follow-up |
| Stress in Children Questionnaire | Child report questionnaire: The Stress in Children Questionnaire assesses child stress | baseline and 1-year follow-up |
| Lifestyle Behavior Checklist | 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 | baseline |
| Dietary Metabolites (Urine) | Metabolites from first-void child urine samples | baseline and 1-year follow-up |
| Video Coding of Meals | 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. | baseline and followup |
| Video Coding of Snack Buffet | 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). | baseline |
| Space Game Task | 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. | Baseline |
| Value Modulated Attentional Capture | 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. | baseline |
| Pavlovian Instrumental Transfer Task | 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 | followup |
| Population Density | The population density of primary home address and school address will be assessed using the National Center for Education Statistics locale definitions. | baseline and followup |
| 34489782 | Background | Fuchs BA, Roberts NJ, Adise S, Pearce AL, Geier CF, White C, Oravecz Z, Keller KL. Decision-Making Processes Related to Perseveration Are Indirectly Associated With Weight Status in Children Through Laboratory-Assessed Energy Intake. Front Psychol. 2021 Aug 18;12:652595. doi: 10.3389/fpsyg.2021.652595. eCollection 2021. |
| 24270272 | Background | Rangel A. Regulation of dietary choice by the decision-making circuitry. Nat Neurosci. 2013 Dec;16(12):1717-24. doi: 10.1038/nn.3561. Epub 2013 Nov 22. |
| 27473844 | Background | van Meer F, Charbonnier L, Smeets PA. Food Decision-Making: Effects of Weight Status and Age. Curr Diab Rep. 2016 Sep;16(9):84. doi: 10.1007/s11892-016-0773-z. |
| 31972203 | Background | Colaizzi JM, Flagel SB, Joyner MA, Gearhardt AN, Stewart JL, Paulus MP. Mapping sign-tracking and goal-tracking onto human behaviors. Neurosci Biobehav Rev. 2020 Apr;111:84-94. doi: 10.1016/j.neubiorev.2020.01.018. Epub 2020 Jan 20. |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Body Composition | The BodPod uses air displacement plethysmography to assess body composition including fat mass and fat-free mass in children | With the BodPod, all models were developed using predominantly white children. Therefore, there is a higher chance of miscalculations with children from other racial/ethnic groups. Additionally, some children were uncomfortable with the procedure and elected to not complete. | Posted | Mean | Standard Deviation | percent body fat | baseline and 1-year follow-up |
|
|
|
| Primary | Food Intake in Grams During a Standard Meal | Intake in grams from standard meal | Posted | Mean | Standard Deviation | grams | baseline and 1-year follow-up |
|
|
|
| Primary | Food Intake in kcal During a Standard Meal | Intake in kcal during a standard meal | Posted | Mean | Standard Deviation | kcal | baseline and 1-year follow-up |
|
|
|
| Primary | Food Intake in Grams During a Snack Buffet When Not Hungry | Intake in grams during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake) | Posted | Mean | Standard Deviation | grams | baseline |
|
|
|
| Primary | Food Intake in kcal During a Snack Buffet When Not Hungry | Intake in kcal during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake) | Posted | Mean | Standard Deviation | kcal | baseline |
|
|
|
| Other Pre-specified | Oxy- and Deoxyhemoglobin in Response to Rating Food Health, Taste, and Wanting | Functional near infrared spectroscopy will measure brain activity through oxy- and deoxyhemoglobin while children rate food images on health, taste and wanting | Not Posted | baseline | Participants |
| Other Pre-specified | Oxy- and Deoxyhemoglobin in Response to Food Choice | Functional near infrared spectroscopy will measure brain activity through oxy- and deoxyhemoglobin while children choose which of two foods they would like to eat | Not Posted | baseline | Participants |
| Other Pre-specified | Oxy- and Deoxyhemoglobin in Response to Consumption of Foods | 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 | Not Posted | 1-year follow-up | Participants |
| Other Pre-specified | Oxy- and Deoxyhemoglobin in Response to Rating Food Taste and Wanting After Consumption | 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 | Not Posted | 1-year follow-up. | Participants |
| Other Pre-specified | Taste Testing to Measure Liking of Foods | 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). | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Child Fullness | 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. | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Physical Activity | 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. | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Sleep Efficiency | 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). | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Children's Anxiety Meter Scale | Self-report questionnaire for child: The Children's Anxiety Meter Scale measures state anxiety before and after the fNRIS session | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Perceived Stress Scale | Self-report questionnaire for child: The Perceived Stress Scale asks the child about feelings over the last month to assess perceived stress | Not Posted | baseline | Participants |
| Other Pre-specified | Loss of Control Eating Questionnaire | 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 | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Demographics | Parental report questionnaire: information describing the cultural, social and financial characteristics of the family. | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Child Pubertal Development Assessment | 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 | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Child Feeding Questionnaire | 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). | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Child Eating Behavior Questionnaire | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | Children's Behavior Questionnaire | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | Behavior Rating Inventory of Executive Function - 2 | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | Binge Eating Scale | 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 | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Child Sleep Habits Questionnaire | 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. | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | External Food Cues Responsiveness Scale | 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. | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Family Food Behavior Survey | 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 | Not Posted | baseline | Participants |
| Other Pre-specified | Sensitivity to Punishment and Reward Questionnaire | 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 | Not Posted | baseline | Participants |
| Other Pre-specified | Three Factor Eating Questionnaire | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | Parent Weight Loss Behavior Questionnaire | Self-report questionnaire for the parent: The Parent Weight Loss Behavior Questionnaire asks parents about their use of healthy and unhealthy weight loss behaviors | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | IQ Estimation | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | Processing Speed and Flexibility | 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 | Not Posted | baseline | Participants |
| Other Pre-specified | NIH Toolbox - Flanker Test | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | NIH Toolbox - List Sorting Test | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | NIH Toolbox - Dimensional Card Sorting Test | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | Child Adiposity | An air displacement plethysmograph (BodPod) will be used to measure child body composition | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Parent Body Mass Index | 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 | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Home Food Inventory | 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. | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Food Frequency Questionnaire | Parental report questionnaire: The HELIX study short, quantitative food frequency questionnaire asks parents to report the frequency with which their child consumes various foods. | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Home Food Environment | Parental report questionnaire: Parents report on various aspect of the home and neighborhood environment | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Structure and Control in Parent Feeding | Parental report questionnaire: The Structure and Control in Parent Feeding is an assessment of parental feeding practices | Not Posted | baseline | Participants |
| Other Pre-specified | Feeding to Manage Child Behavior Questionnaire | 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 | Not Posted | baseline | Participants |
| Other Pre-specified | Body Image Scale | Child report questionnaire: The Body Image Scale assesses children's own perception of their body size and their ideal body size | Not Posted | 1-year follow-up | Participants |
| Other Pre-specified | Weight Concerns Scale | Child report questionnaire: The Weight Concerns Scale assesses the extent to which children are concerned about their weight | Not Posted | 1-year follow-up | Participants |
| Other Pre-specified | Stress in Children Questionnaire | Child report questionnaire: The Stress in Children Questionnaire assesses child stress | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Lifestyle Behavior Checklist | 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 | Not Posted | baseline | Participants |
| Other Pre-specified | Dietary Metabolites (Urine) | Metabolites from first-void child urine samples | Not Posted | baseline and 1-year follow-up | Participants |
| Other Pre-specified | Video Coding of Meals | 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. | Not Posted | baseline and followup | Participants |
| Other Pre-specified | Video Coding of Snack Buffet | 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). | Not Posted | baseline | Participants |
| Other Pre-specified | Space Game Task | 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. | Not Posted | Baseline | Participants |
| Other Pre-specified | Value Modulated Attentional Capture | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | Pavlovian Instrumental Transfer Task | 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 | Not Posted | followup | Participants |
| Other Pre-specified | Population Density | The population density of primary home address and school address will be assessed using the National Center for Education Statistics locale definitions. | Not Posted | baseline and followup | Participants |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | 1-year Follow-up | follow-up after 1 year | 0 | 63 | 0 | 63 | 0 | 63 |
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |