Brain Mechanisms of Overeating in Children (RO1)

December 28, 2023 updated by: Kathleen Loralee Keller, Penn State University
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.

Study Overview

Status

Completed

Conditions

Detailed Description

In aim one, 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.

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

Third, the investigators will determine the relationship between brain response to large portions and other validated measures of overeating, including satiety responsiveness and the amount of calories children consumed from high calorie snacks when they are not hungry (i.e., eating in the absence of hunger).

Fourth, the investigators will conduct follow-up visits one year after baseline to 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).

Secondary study endpoints include the relationship between child behavioral and brain response to food portion size and physical activity assessed by accelerometry and questionnaires, inhibitory control assessed by a stop signal test, reward-related design making assessed by a computer task, working memory assessed by an N-back task loss of control eating, child sleep, child working memory, child meal microstructure assessed by observational meal coding, parent rated eating behaviors, and parental feeding practices.

Study Type

Observational

Enrollment (Actual)

254

Contacts and Locations

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

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • The Pennsylvania State University

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

Ages Eligible for Study

7 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Responses to Portion Size
Time Frame: baseline
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
Time Frame: baseline
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
Time Frame: From baseline visit to 1 year later
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Response Relationships
Time Frame: baseline
The investigators will determine the relationship between brain response to large portions and other validated measures of overeating, including satiety responsiveness and the amount of calories children consumed from high calorie snacks when they are not hungry (i.e., eating in the absence of hunger).
baseline
Inhibitory control assessed by a Stop Signal test
Time Frame: baseline
An additional endpoint includes the relationship between child behavioral and brain response to food portion size and Inhibitory control assessed by a Stop Signal test.
baseline
Reward-related design
Time Frame: baseline and 1 year later
Reward-related design making assessed by a computer task.
baseline and 1 year later
Working memory
Time Frame: baseline and 1 year later
Working memory assessed by an N-back task.
baseline and 1 year later
Meal microstructure
Time Frame: baseline and 1 year later
Meal microstructure assessed by observational meal coding.
baseline and 1 year later
Eating in the absence of hunger
Time Frame: baseline and 1 year later
Assessing child eating in the absence of hunger by buffet meal intake.
baseline and 1 year later

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: baseline
An additional endpoint include the relationship between child behavioral and brain response to food portion size and physical activity assessed by accelerometry.
baseline
Loss of control eating
Time Frame: baseline
An additional endpoint include the relationship between child behavioral and brain response to food portion size and Loss of control eating.
baseline
Parent-described eating behaviors
Time Frame: baseline
An additional endpoint includes the relationship between child behavioral and brain response to food portion size and Parent-described eating behaviors.
baseline

Collaborators and Investigators

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

Sponsor

Penn State University

Investigators

  • Principal Investigator: Kathleen L Keller, Ph.D., Penn State University

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

Helpful Links

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)

January 31, 2018

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RO1 Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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