Pediatric ObesityRO1NCT03341247
Brain Mechanisms of Overeating in Children
An observational study of Pediatric Obesity and Inhibition, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Inhibition, Decision Making
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 20 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Parents and their 7-8 year old children in Centre County, Pennsylvania and surrounding areas.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
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.
Read the 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.
- Conditions
- Pediatric Obesity, Inhibition, Decision Making, fMRI
- Keywords
- Obesity, Portion Size Effect, fMRI, Functional Magnetic Resonance Imaging, Inhibition, Decision Making, Satiety Responsiveness, Anthropometrics, DXA, Reward Processing, Working Memory, Meal microstructure
- Medical subject headings
- Pediatric Obesity, Inhibition, Psychological, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Brain Responses to Portion Size
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.
Measured: baseline
Food Intake Relationship to Portion Size
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.
Measured: baseline
The Change in DXA analysis of child adiposity after 1 year
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.
Measured: From baseline visit to 1 year later
Secondary outcomes (6)
Brain Response Relationships
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).
Measured: baseline
Inhibitory control assessed by a Stop Signal test
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.
Measured: baseline
Reward-related design
Reward-related design making assessed by a computer task.
Measured: baseline and 1 year later
Working memory
Working memory assessed by an N-back task.
Measured: baseline and 1 year later
Meal microstructure
Meal microstructure assessed by observational meal coding.
Measured: baseline and 1 year later
Eating in the absence of hunger
Assessing child eating in the absence of hunger by buffet meal intake.
Measured: baseline and 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start31 Jan 2018
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Loralee Keller, Penn State University
- Investigators
- Kathleen L Keller, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341247
- Sponsor's protocol ID
- RO1 Study
- Acronym
- RO1
- Status last verified
- Dec 2023
- First submitted
- 11 Oct 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 21999692Bruce 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.
PubMed 21291906De 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.
PubMed 22719753French 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.
PubMed 24510841Grammer 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.
PubMed 24631799Morrell, 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.
PubMed 19501758Tanner, J.M. (1962). Growth at adolescence.(Oxford: Blackwell Scientific Publications).
Bhat YR, Keller KL, Brick TR, Pearce AL. ByteTrack: a deep learning approach for bite count and bite rate detection using meal videos in children. Front Nutr. 2025 Oct 3;12:1610363. doi: 10.3389/fnut.2025.1610363. eCollection 2025.
PubMed 41112744Neuwald NV, Pearce AL, Cunningham PM, Setzenfand MN, Koczwara L, Rolls BJ, Keller KL. Food switching at a meal is positively associated with change in adiposity among children at high-familial risk for obesity. Appetite. 2025 Apr 1;208:107915. doi: 10.1016/j.appet.2025.107915. Epub 2025 Feb 25.
PubMed 40010570Bhat YR, Rolls BJ, Wilson SJ, Rose E, Geier CF, Fuchs B, Garavan H, Keller KL. Eating in the Absence of Hunger Is a Stable Predictor of Adiposity Gains in Middle Childhood. J Nutr. 2024 Dec;154(12):3726-3739. doi: 10.1016/j.tjnut.2024.10.008. Epub 2024 Oct 10.
PubMed 39393498Keller KL, Pearce AL, Fuchs B, Rolls BJ, Wilson SJ, Geier CF, Rose E, Garavan H. PACE: a Novel Eating Behavior Phenotype to Assess Risk for Obesity in Middle Childhood. J Nutr. 2024 Jul;154(7):2176-2187. doi: 10.1016/j.tjnut.2024.05.019. Epub 2024 May 23.
PubMed 38795747Neuwald NV, Pearce AL, Cunningham PM, Koczwara L, Setzenfand MN, Rolls BJ, Keller KL. Switching between foods is reliably associated with intake across eating events in children. Appetite. 2024 Jun 1;197:107325. doi: 10.1016/j.appet.2024.107325. Epub 2024 Mar 26.
PubMed 38548135
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms of Overeating in Children
- ClinicalTrials.gov ID
- NCT03341247
- Acronym / sponsor ID
- RO1 / RO1 Study
- Conditions
- Pediatric Obesity, Inhibition, Decision Making, fMRI
- Keywords
- Obesity, Portion Size Effect, fMRI, Functional Magnetic Resonance Imaging, Inhibition, Decision Making, Satiety Responsiveness, Anthropometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Parents and their 7-8 year old children in Centre County, Pennsylvania and surrounding areas.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Brain Response Relationships
Time frame: baseline
Inhibitory control assessed by a Stop Signal test
Time frame: baseline
Reward-related design
Time frame: baseline and 1 year later
Working memory
Time frame: baseline and 1 year later
Meal microstructure
Time frame: baseline and 1 year later
Eating in the absence of hunger
Time frame: baseline and 1 year later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 21999692Burger 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.
- Background: PubMed 21291906Bruce 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.
- Background: PubMed 22719753De 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.
- Background: PubMed 24510841French 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.
- Background: PubMed 24631799Grammer 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.
- BackgroundMorrell, 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.
- Background: PubMed 19501758Tetley 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.
- BackgroundTanner, J.M. (1962). Growth at adolescence.(Oxford: Blackwell Scientific Publications).
- Derived from this study: PubMed 41112744Bhat YR, Keller KL, Brick TR, Pearce AL. ByteTrack: a deep learning approach for bite count and bite rate detection using meal videos in children. Front Nutr. 2025 Oct 3;12:1610363. doi: 10.3389/fnut.2025.1610363. eCollection 2025.
- Derived from this study: PubMed 40010570Neuwald NV, Pearce AL, Cunningham PM, Setzenfand MN, Koczwara L, Rolls BJ, Keller KL. Food switching at a meal is positively associated with change in adiposity among children at high-familial risk for obesity. Appetite. 2025 Apr 1;208:107915. doi: 10.1016/j.appet.2025.107915. Epub 2025 Feb 25.
- Derived from this study: PubMed 39393498Bhat YR, Rolls BJ, Wilson SJ, Rose E, Geier CF, Fuchs B, Garavan H, Keller KL. Eating in the Absence of Hunger Is a Stable Predictor of Adiposity Gains in Middle Childhood. J Nutr. 2024 Dec;154(12):3726-3739. doi: 10.1016/j.tjnut.2024.10.008. Epub 2024 Oct 10.
- Derived from this study: PubMed 38795747Keller KL, Pearce AL, Fuchs B, Rolls BJ, Wilson SJ, Geier CF, Rose E, Garavan H. PACE: a Novel Eating Behavior Phenotype to Assess Risk for Obesity in Middle Childhood. J Nutr. 2024 Jul;154(7):2176-2187. doi: 10.1016/j.tjnut.2024.05.019. Epub 2024 May 23.
- Dr. Kathleen Keller's current researchLink provided by the sponsor.
- Dr. Stephen Wilson's current researchLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen L Keller, Ph.D. principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity and Inhibition, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Responses to Portion Size (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03341247, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.