Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brain Mechanisms of Overeating in Children (RO1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03341247
Recruitment Status : Enrolling by invitation
First Posted : November 14, 2017
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Kathleen Loralee Keller, Penn State University

Tracking Information
First Submitted Date October 11, 2017
First Posted Date November 14, 2017
Last Update Posted Date January 14, 2021
Actual Study Start Date January 31, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 11, 2021)
  • 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).
  • 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.
  • Reward-related design [ Time Frame: baseline and 1 year later ]
    Reward-related design making assessed by a computer task.
  • Working memory [ Time Frame: baseline and 1 year later ]
    Working memory assessed by an N-back task.
  • Meal microstructure [ Time Frame: baseline and 1 year later ]
    Meal microstructure assessed by observational meal coding.
  • 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.
Original Secondary Outcome Measures
 (submitted: November 13, 2017)
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).
Current Other Pre-specified Outcome Measures
 (submitted: January 11, 2021)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: November 13, 2017)
  • 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.
  • Inhibitory control assessed by a go/no go 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 go/no go test.
  • 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.
  • Parent-described eating behaviors [ Time Frame: baseline ]
    An additional endpoint include the relationship between child behavioral and brain response to food portion size and Parent-described eating behaviors.
 
Descriptive Information
Brief Title Brain Mechanisms of Overeating in Children
Official Title Brain Mechanisms of Overeating in Children
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.
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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Parents and their 7-8 year old children in Centre County, Pennsylvania and surrounding areas.
Condition
  • Pediatric Obesity
  • Inhibition
  • Decision Making
  • fMRI
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: January 11, 2021)
240
Original Estimated Enrollment
 (submitted: November 13, 2017)
120
Estimated Study Completion Date December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 8 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03341247
Other Study ID Numbers RO1 Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
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.
Responsible Party Kathleen Loralee Keller, Penn State University
Study Sponsor Penn State University
Collaborators Not Provided
Investigators
Principal Investigator: Kathleen L Keller, Ph.D. Penn State University
PRS Account Penn State University
Verification Date January 2021