Study of Brain, Reward, and Kids' Eating (BRAKE)

March 24, 2026 updated by: Alaina Pearce, Penn State University

Neurocognitive and Behavioral Factors That Promote Resiliency to Pediatric Obesity

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alaina L Pearce, PhD
  • Phone Number: 814-863-2120
  • Email: azp271@psu.edu

Study Contact Backup

  • Name: Kathleen L Keller, PhD
  • Phone Number: 814-863-2915
  • Email: klk37@psu.edu

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Chandlee Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Study Population

Children will be recruited from the local community in central PA. The sample will included children from both metropolitan and non-metropolitan areas.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: All participants
There is only 1 arm in this study
Behavioral: Food Rating
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline and 1-year follow-up
Child Body Mass Index
Time Frame: baseline and 1 year follow-up
child height and weight will be measured
baseline and 1 year follow-up
Food Intake in Grams During a Standard Meal
Time Frame: baseline and 1-year follow-up
Intake in grams from standard meal
baseline and 1-year follow-up
Food Intake in kcal During a Standard Meal
Time Frame: baseline and 1-year follow-up
Intake in kcal during a standard meal
baseline and 1-year follow-up
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)
baseline
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)
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline
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
baseline
Eye-tracking during the value-modulated attentional capture task
Time Frame: baseline
The extent to which previously reward distractors capture attention will be assessed with eye tracking
baseline
Eye-tracking during the food choice task (during functional near infrared spectroscopy)
Time Frame: baseline
Eye-tracking will be measured to determine if attention is drawn to the tastier food item prior to making a food choice
baseline
Video coding of snack buffet
Time Frame: baseline
A digital recording of the child during the eating in the absence of hunger protocol will be saved. We will use the video to characterize the amount of attention children give toward the food items when they are not hungry and code behaviors associated with self-control
baseline
Population density
Time Frame: baseline
The population density of the child's primary residence will be used as a measure of rurality
baseline
Child Pavlovian Instrumental Transfer Task
Time Frame: 1-year follow-up
An experimental task assessing pavlovian instrumental transfer for food cues.
1-year follow-up
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
1-year follow-up
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
1-year follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
baseline
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.
baseline
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.
baseline
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.
baseline
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
baseline
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
baseline
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.
baseline
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.
baseline
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.
baseline
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.
baseline
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).
baseline and 1-year follow-up
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
baseline and 1-year follow-up
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
baseline and 1-year follow-up
Demographics
Time Frame: baseline and 1-year follow-up
Parental report questionnaire: information describing the cultural, social and financial characteristics of the family.
baseline and 1-year follow-up
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).
baseline and 1-year follow-up
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
baseline and 1-year follow-up
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.
baseline and 1-year follow-up
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.
baseline and 1-year follow-up
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
baseline and 1-year follow-up
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.
baseline and 1-year follow-up
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.
baseline and 1-year follow-up
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
baseline and 1-year follow-up
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
baseline
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
baseline
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
1-year follow-up
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
1-year follow-up
Stress in Children Questionnaire
Time Frame: baseline and 1-year follow-up
Child report questionnaire: The Stress in Children Questionnaire assesses child stress
baseline and 1-year follow-up
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
baseline
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
baseline
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
baseline
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
1-year follow-up
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
1-year follow-up.
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).
baseline and 1-year follow-up
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.
baseline and 1-year follow-up
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.
baseline and 1-year follow-up
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
baseline and 1-year follow-up
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.
baseline
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
baseline
Child Adiposity
Time Frame: baseline and 1-year follow-up
An air displacement plethysmograph (BodPod) will be used to measure child body composition
baseline and 1-year follow-up
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
baseline and 1-year follow-up
Dietary Metabolites (Urine)
Time Frame: baseline and 1-year follow-up
Metabolites from first-void child urine samples
baseline and 1-year follow-up
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.
baseline and followup
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).
baseline
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.
Baseline
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.
baseline
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
followup
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.
baseline and followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Advancing Translational Sciences (NCATS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00020463
  • KL2TR002015 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will be available within 6 mo of completion of data collection

IPD Sharing Access Criteria

No access criteria

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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