NCT03341247

Brief Summary

The proposed research will follow healthy weight children who vary by family risk for obesity to identify the neurobiological and appetitive traits that are implicated in overeating and weight gain during the critical pre-adolescent period. The investigator's central hypothesis is that increased intake from large portions of energy dense foods is due in part to reduced activity in brain regions implicated in inhibitory control and decision making, combined with increased activity in reward processing pathways. To test this hypothesis, the investigators will recruit 120 healthy weight children, aged 7-8 years, at two levels of obesity risk (i.e., 60 high-risk and 60 low-risk) based on parent weight status. This will result in 240 participants: 120 children and their parents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

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

October 11, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

5.4 years

First QC Date

October 11, 2017

Last Update Submit

December 28, 2023

Conditions

Keywords

ObesityPortion Size EffectfMRIFunctional Magnetic Resonance ImagingInhibitionDecision MakingSatiety ResponsivenessAnthropometricsDXAReward ProcessingWorking MemoryMeal microstructure

Outcome Measures

Primary Outcomes (3)

  • Brain Responses to Portion Size

    The investigators will use functional magnetic resonance imaging to characterize the brain regions which are activated in response to food portion size and compare these regions between high- and low-risk children.

    baseline

  • Food Intake Relationship to Portion Size

    The investigators will determine the relationship between brain response to visual portion size cues and measured food intake when portions are increased in laboratory meals.

    baseline

  • The Change in DXA analysis of child adiposity after 1 year

    The investigators will determine the extent to which baseline brain and behavioral responses to portion size predict gains in adiposity assessed by anthropometrics (body weight, height, and dual-energy x-ray absorptiometry). Body weight (kg) and Height (m) will be aggregated to report BMI in kg/m\^2.

    From baseline visit to 1 year later

Secondary Outcomes (6)

  • Brain Response Relationships

    baseline

  • Inhibitory control assessed by a Stop Signal test

    baseline

  • Reward-related design

    baseline and 1 year later

  • Working memory

    baseline and 1 year later

  • Meal microstructure

    baseline and 1 year later

  • +1 more secondary outcomes

Other Outcomes (3)

  • Physical Activity

    baseline

  • Loss of control eating

    baseline

  • Parent-described eating behaviors

    baseline

Study Arms (2)

Low-risk of obesity

Children whose biological mother and biological father have a body mass index between 18.5 - 25 kg/m2.

High-risk of obesity

Children whose biological mother has a body mass index greater than or equal to 30 kg/m2 and whose biological father have a body mass index greater than or equal to 25 kg/m2.

Eligibility Criteria

Age7 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Parents and their 7-8 year old children in Centre County, Pennsylvania and surrounding areas.

You may qualify if:

  • Child is in good health based on parental self-report
  • Child has no learning disabilities (e.g., ADHD)
  • Child has no diagnosed psychological or medical conditions/devices, or metal in/on the body that may impact comfort or safety in the fMRI (e.g., anxiety, insulin pump)
  • Child is not on any medications known to influence body weight, taste, food intake, behavior, or blood flow
  • Child is not claustrophobic
  • Child is between the ages of 7-8 years-old at enrollment
  • Child's immediate family members have not been diagnosed with a psychological disorder, including depression, anxiety, schizophrenia, etc.
  • Child's biological mother and biological father have a body mass index either between 18.5 - 25 kg/m2 (low-risk group) or biological mother has a body mass index greater than or equal to 30 kg/m2 and biological father has a body mass index greater than or equal to 25 kg/m2 (high-risk group)
  • Child's parent participating in study must be available to attend visits with child

You may not qualify if:

  • Child is not in good health based on parent self-report
  • Child has any learning disabilities (e.g., ADHD)
  • Child has any psychological or medical conditions/devices that may impact comfort in the fMRI (e.g., anxiety, insulin pump)
  • Child is taking any medications known to influence body weight, taste, food intake, behavior, or blood flow
  • Child is claustrophobic
  • Child is less than 7 or greater than 8 years-old at enrollment
  • Child has any immediate family members diagnosed with a psychological disorder, including depression, anxiety, schizophrenia, etc.
  • Child's biological mother or biological father's body mass index do not fit into the parameters for either group (both biological parents \< 18.5 for low-risk group or biological mother is \< 30 and biological father is \< 25 for high-risk group)
  • Child's parent participating in study is not available to attend visits with child
  • Child is blue/green colorblind
  • Child is not fluent in the English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (12)

  • Burger KS, Stice E. Variability in reward responsivity and obesity: evidence from brain imaging studies. Curr Drug Abuse Rev. 2011 Sep;4(3):182-9. doi: 10.2174/1874473711104030182.

    PMID: 21999692BACKGROUND
  • Bruce AS, Martin LE, Savage CR. Neural correlates of pediatric obesity. Prev Med. 2011 Jun;52 Suppl 1:S29-35. doi: 10.1016/j.ypmed.2011.01.018. Epub 2011 Feb 1.

    PMID: 21291906BACKGROUND
  • De Silva A, Salem V, Matthews PM, Dhillo WS. The use of functional MRI to study appetite control in the CNS. Exp Diabetes Res. 2012;2012:764017. doi: 10.1155/2012/764017. Epub 2012 May 8.

    PMID: 22719753BACKGROUND
  • French SA, Mitchell NR, Wolfson J, Harnack LJ, Jeffery RW, Gerlach AF, Blundell JE, Pentel PR. Portion size effects on weight gain in a free living setting. Obesity (Silver Spring). 2014 Jun;22(6):1400-5. doi: 10.1002/oby.20720. Epub 2014 Feb 19.

    PMID: 24510841BACKGROUND
  • Grammer JK, Carrasco M, Gehring WJ, Morrison FJ. Age-related changes in error processing in young children: a school-based investigation. Dev Cogn Neurosci. 2014 Jul;9:93-105. doi: 10.1016/j.dcn.2014.02.001. Epub 2014 Feb 11.

    PMID: 24631799BACKGROUND
  • Morrell, J. (1999). The Infant Sleep Questionnaire: A new tool to assess infant sleep problems for clinical and research purposes. Child Psychology and Psychiatry Review 4, 20-26.

    BACKGROUND
  • Tetley A, Brunstrom J, Griffiths P. Individual differences in food-cue reactivity. The role of BMI and everyday portion-size selections. Appetite. 2009 Jun;52(3):614-620. doi: 10.1016/j.appet.2009.02.005. Epub 2009 Feb 25.

    PMID: 19501758BACKGROUND
  • Tanner, J.M. (1962). Growth at adolescence.(Oxford: Blackwell Scientific Publications).

    BACKGROUND
  • Bhat YR, Keller KL, Brick TR, Pearce AL. ByteTrack: a deep learning approach for bite count and bite rate detection using meal videos in children. Front Nutr. 2025 Oct 3;12:1610363. doi: 10.3389/fnut.2025.1610363. eCollection 2025.

  • Bhat YR, Rolls BJ, Wilson SJ, Rose E, Geier CF, Fuchs B, Garavan H, Keller KL. Eating in the Absence of Hunger Is a Stable Predictor of Adiposity Gains in Middle Childhood. J Nutr. 2024 Dec;154(12):3726-3739. doi: 10.1016/j.tjnut.2024.10.008. Epub 2024 Oct 10.

  • Keller KL, Pearce AL, Fuchs B, Rolls BJ, Wilson SJ, Geier CF, Rose E, Garavan H. PACE: a Novel Eating Behavior Phenotype to Assess Risk for Obesity in Middle Childhood. J Nutr. 2024 Jul;154(7):2176-2187. doi: 10.1016/j.tjnut.2024.05.019. Epub 2024 May 23.

  • Neuwald NV, Pearce AL, Cunningham PM, Koczwara L, Setzenfand MN, Rolls BJ, Keller KL. Switching between foods is reliably associated with intake across eating events in children. Appetite. 2024 Jun 1;197:107325. doi: 10.1016/j.appet.2024.107325. Epub 2024 Mar 26.

Related Links

MeSH Terms

Conditions

Pediatric ObesityInhibition, PsychologicalObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Kathleen L Keller, Ph.D.

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 11, 2017

First Posted

November 14, 2017

Study Start

January 31, 2018

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

January 3, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

De-identified data will be shared with other investigators by special request made by email to the PI (Kathleen L. Keller klk37@psu.edu). For investigators who request use of the data, we will request acknowledgement of our research group and Penn State University in any public presentation of the results obtained from this study.

Locations