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Obesity, ChildhoodBRAKENCT05456516

Study of Brain, Reward, and Kids' Eating

A study testing Food Rating in people with Obesity, Childhood and Eating Behavior, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 8 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood, Eating Behavior
What is being tested?
Food Rating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
10 Jan 2023to 30 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 9Show fewer
  • is allergic to foods or ingredients used in the study.
  • Parent Exclusion Criteria:
  • the parent is unable to attend the study visits

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chandlee Laboratory

    University Park, Pennsylvania, 16802

Other trials in United States

About this study

Official title: 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).

Being tested
Food Rating
Keywords
reinforcement learning, fNIRS, food-cue reactivity
Medical subject headings
Pediatric Obesity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food RatingBehavioural

    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

Study groups in NCT05456516
Study groupRoleWhat they receive
All participantsOtherThere is only 1 arm in this study
Receives: Behavioral: Food Rating

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child Body Mass Index

    child height and weight will be measured

    Measured: baseline and 1 year follow-up

  2. Body Composition

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

    Measured: baseline and 1-year follow-up

  3. Food Intake in Grams During a Standard Meal

    Intake in grams from standard meal

    Measured: baseline and 1-year follow-up

  4. Food Intake in kcal During a Standard Meal

    Intake in kcal during a standard meal

    Measured: baseline and 1-year follow-up

  5. 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)

    Measured: baseline

  6. 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)

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start10 Jan 2023
  3. Primary completion30 Dec 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05456516
Sponsor's protocol ID
STUDY00020463
Other IDs
KL2TR002015
Acronym
BRAKE
Status last verified
Mar 2026
First submitted
6 Jul 2022
Last updated
13 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 32505786

  • 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.

    PubMed 34662600

  • 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.

    PubMed 34489782

  • 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.

    PubMed 24270272

  • 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.

    PubMed 27473844

  • 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.

    PubMed 31972203

Questions about this trial

What is this clinical trial studying?

A study testing Food Rating in people with Obesity, Childhood and Eating Behavior, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Body Mass Index (time frame: baseline and 1 year follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05456516, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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