RO1: Brain Mechanisms of Overeating in Children

Sponsor

Penn State University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03341247

Collaborator

(none)

240

Enrollment

Location

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity Inhibition Decision Making fMRI

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 Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Brain Mechanisms of Overeating in Children

Actual Study Start Date :

Jan 31, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Brain Responses to Portion Size [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 [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 [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.

Secondary Outcome Measures

Brain Response Relationships [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 [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 [baseline and 1 year later]
Reward-related design making assessed by a computer task.
Working memory [baseline and 1 year later]
Working memory assessed by an N-back task.
Meal microstructure [baseline and 1 year later]
Meal microstructure assessed by observational meal coding.
Eating in the absence of hunger [baseline and 1 year later]
Assessing child eating in the absence of hunger by buffet meal intake.

Other Outcome Measures

Physical Activity [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 [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 [baseline]
An additional endpoint includes the relationship between child behavioral and brain response to food portion size and Parent-described eating behaviors.

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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