Brain Mechanisms of Overeating in Children (RO1)

• ClinicalTrials.gov Identifier: NCT03341247
• Recruitment Status: Enrolling by invitation
• First Posted: November 14, 2017
• Last Update Posted: April 1, 2022
• Sponsor: Penn State University
• Information provided by (Responsible Party): Kathleen Loralee Keller, Penn State University

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
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
• Estimated Enrollment: 240 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Brain Mechanisms of Overeating in Children
• Actual Study Start Date: January 31, 2018
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: December 31, 2023

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 8 Years (Child)
• Sexes Eligible for Study: All
• 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.

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

Contacts and Locations

Locations

United States, Pennsylvania

The Pennsylvania State University

University Park, Pennsylvania, United States, 16802

Sponsors and Collaborators

Penn State University

Investigators

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

More Information

Additional Information:

Dr. Kathleen Keller's current research 

Dr. Barbara Rolls' current research 

Dr. Stephen Wilson's current research 

Publications:

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.

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.

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.

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.

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.

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.

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.

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

• Responsible Party: Kathleen Loralee Keller, Director, Penn State University
• ClinicalTrials.gov Identifier: NCT03341247
• Other Study ID Numbers: RO1 Study
• First Posted: November 14, 2017
• Last Update Posted: April 1, 2022
• Last Verified: March 2022

Individual Participant Data (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathleen Loralee Keller, Penn State University:

Obesity; Portion Size Effect; fMRI; Functional Magnetic Resonance Imaging; Inhibition; Decision Making; Satiety Responsiveness; Anthropometrics; DXA; Reward Processing; Working Memory; Meal microstructure

Additional relevant MeSH terms:

Pediatric Obesity; Hyperphagia; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Digestive