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OpenTrials
Completed

NCT Number: NCT03341247

Brain Mechanisms of Overeating in Children

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.

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Key information

Age range

7 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. Reward-related design

    Time frame: baseline and 1 year later

    Reward-related design making assessed by a computer task.

  4. Working memory

    Time frame: baseline and 1 year later

    Working memory assessed by an N-back task.

  5. Meal microstructure

    Time frame: baseline and 1 year later

    Meal microstructure assessed by observational meal coding.

  6. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Acronym: RO1

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2017
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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