NCT05456516

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

July 6, 2022

Results QC Date

February 11, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

reinforcement learningfNIRSfood-cue reactivity

Outcome Measures

Primary Outcomes (6)

  • 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

Other Outcomes (47)

  • Oxy- and Deoxyhemoglobin in Response to Rating Food Health, Taste, and Wanting

    baseline

  • Oxy- and Deoxyhemoglobin in Response to Food Choice

    baseline

  • Oxy- and Deoxyhemoglobin in Response to Consumption of Foods

    1-year follow-up

  • +44 more other outcomes

Study Arms (1)

All participants

OTHER

There is only 1 arm in this study

Behavioral: Food Rating

Interventions

Food RatingBEHAVIORAL

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

All participants

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • the parent is unable to attend the study visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chandlee Laboratory

University Park, Pennsylvania, 16802, United States

Location

Related Publications (6)

  • 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.

    PMID: 32505786BACKGROUND
  • 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.

    PMID: 34662600BACKGROUND
  • 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.

    PMID: 34489782BACKGROUND
  • 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.

    PMID: 24270272BACKGROUND
  • 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.

    PMID: 27473844BACKGROUND
  • 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.

    PMID: 31972203BACKGROUND

MeSH Terms

Conditions

Pediatric ObesityFeeding Behavior

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Results Point of Contact

Title
Alaina Pearce
Organization
Pennsylvania State University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 13, 2022

Study Start

January 10, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

April 13, 2026

Results First Posted

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
The data will be available within 6 mo of completion of data collection
Access Criteria
No access criteria

Locations