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Study of Brain, Reward, and Kids' Eating

Neurocognitive and Behavioral Factors That Promote Resiliency to Pediatric Obesity

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05456516
Acronym
BRAKE
Enrollment
76
Registered
2022-07-13
Start date
2023-01-10
Completion date
2024-12-30
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Behavior, Obesity, Childhood

Keywords

reinforcement learning, fNIRS, food-cue reactivity

Brief 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). 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).

Interventions

BEHAVIORALFood 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

Sponsors

Penn State University
Lead SponsorOTHER
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Child Body Mass Indexbaseline and 1 year follow-upchild height and weight will be measured
Body Compositionbaseline and 1-year follow-upThe BodPod uses air displacement plethysmography to assess body composition including fat mass and fat-free mass in children
Food Intake in Grams During a Standard Mealbaseline and 1-year follow-upIntake in grams from standard meal
Food Intake in kcal During a Standard Mealbaseline and 1-year follow-upIntake in kcal during a standard meal
Food Intake in Grams During a Snack Buffet When Not HungrybaselineIntake in grams during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)
Food Intake in kcal During a Snack Buffet When Not HungrybaselineIntake in kcal during a snack buffet using a standard eating in the absence of hunger paradigm (i.e., non-homeostatic intake)

Countries

United States

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
76 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
76 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
3 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
66 Participants
Sex: Female, Male
Female
48 Participants
Sex: Female, Male
Male
28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 760 / 63
other
Total, other adverse events
0 / 760 / 63
serious
Total, serious adverse events
0 / 760 / 63

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026