Pediatric ObesityNCT02759523
Neural Mechanisms Underlying Children's Responses to Food Portion Size and Energy Density
An observational study of Pediatric Obesity, run by Penn State University.
Trial summary
Increased portion sizes of foods high in energy density (calories per gram of food) have been implicated in the obesity epidemic. Numerous studies show that children and adults eat more from larger portions of food than they do from smaller portions, a response known as the portion size effect. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Dec 2015
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between the ages of 7-10 years old and their parents
Who may be able to join
- Right-handedness
- English as native language
- Reading at /above grade level
- Not claustrophobic
- Generally healthy
Who cannot join
- Left-handedness
- Metal in or on the body that cannot be removed
- Claustrophobic
- Medication usage that could alter brain activity
- Medical disorder that may impact comfort in scanner
- Food allergies
About this study
Increased portion sizes of foods high in energy density (calories per gram of food) have been implicated in the obesity epidemic. Numerous studies show that children and adults eat more from larger portions of food than they do from smaller portions, a response known as the portion size effect. Despite the robust and consistent nature of these findings, the mechanisms underlying the portion size effect are not known. The long-term goal of this research is to identify the neural mechanisms involved in the portion size effect so that this information can be used to develop effective weight-management strategies. Differences in neural response to food cues, as demonstrated by functional magnetic resonance imaging (fMRI), can help clarify the factors that determine susceptibility to large portions. The goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children.
The investigators hypothesize that high relative to low energy density food images will be associated with increased activation in regions of the brain involved in reward- and sensory- processing and that large relative to small portion size food images will be associated with increased activation in regions of the brain involved in cognitive control. In addition, the investigators hypothesize that these brain responses will influence the relationship between portion size served and energy intake at laboratory meals.
Read the detailed description
What this study will add to the literature: The response to food images that vary by portion size using fMRI has not been previously reported. Furthermore, how the brain response to food portion size and energy density is related to energy intake has not been previously reported. The goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children.
- Conditions
- Pediatric Obesity
- Keywords
- Magnetic Resonance Imaging, Portion Size, Energy Intake
- Medical subject headings
- Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI blood oxygen level dependent (BOLD) response to food portion size and energy density
Whole-brain response to food images that varied at 2 levels of portion size and 2 levels of energy density
Measured: Collected at fMRI scan (1 of 1) at week 5
Energy intake
Energy intake (kcal and grams) of foods consumed ad libitum at each laboratory test-meal in response to 4 conditions of portion sizes (100% reference, 133%, 167%, 200%).
Measured: Collected at week 1, 2, 3, and 4
Secondary outcomes (1)
Region of Interest (ROI)-response to food portion size and energy density
Response in selected brain regions of interest to food images varied at 2 levels of portion size and 2 levels of energy density
Measured: Collected at fMRI scan (1 of 1) at week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Other
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Social Science Research Institute
- Responsible party
- Principal investigator, Kathleen Loralee Keller, Penn State University
- Investigators
- Kathleen Keller, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759523
- Sponsor's protocol ID
- FoodBehavior01
- Status last verified
- Dec 2020
- First submitted
- 26 Apr 2016
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
English L, Lasschuijt M, Keller KL. Mechanisms of the portion size effect. What is known and where do we go from here? Appetite. 2015 May;88:39-49. doi: 10.1016/j.appet.2014.11.004. Epub 2014 Nov 11.
PubMed 25447010Fearnbach SN, English LK, Lasschuijt M, Wilson SJ, Savage JS, Fisher JO, Rolls BJ, Keller KL. Brain response to images of food varying in energy density is associated with body composition in 7- to 10-year-old children: Results of an exploratory study. Physiol Behav. 2016 Aug 1;162:3-9. doi: 10.1016/j.physbeh.2016.03.007. Epub 2016 Mar 10.
PubMed 26973134Neuwald 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 40010570Diktas HE, Keller KL, Roe LS, Rolls BJ. Children's Portion Selection Is Predicted by Food Liking and Is Related to Intake in Response to Increased Portions. J Nutr. 2022 Oct 6;152(10):2287-2296. doi: 10.1093/jn/nxac162.
PubMed 35883226Keller KL, English LK, Fearnbach SN, Lasschuijt M, Anderson K, Bermudez M, Fisher JO, Rolls BJ, Wilson SJ. Brain response to food cues varying in portion size is associated with individual differences in the portion size effect in children. Appetite. 2018 Jun 1;125:139-151. doi: 10.1016/j.appet.2018.01.027. Epub 2018 Feb 2.
PubMed 29408590
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms Underlying Children's Responses to Food Portion Size and Energy Density
- ClinicalTrials.gov ID
- NCT02759523
- Acronym / sponsor ID
- FoodBehavior01
- Conditions
- Pediatric Obesity
- Keywords
- Magnetic Resonance Imaging, Portion Size, Energy Intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Social Science Research Institute
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 May 2016 (estimated)
- 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.
Increased portion sizes of foods high in energy density (calories per gram of food) have been implicated in the obesity epidemic. Numerous studies show that children and adults eat more from larger portions of food than they do from smaller portions, a response known as the portion size effect. Despite the robust and consistent nature of these findings, the mechanisms underlying the portion size effect are not known. The long-term goal of this research is to identify the neural mechanisms involved in the portion size effect so that this information can be used to develop effective weight-management strategies. Differences in neural response to food cues, as demonstrated by functional magnetic resonance imaging (fMRI), can help clarify the factors that determine susceptibility to large portions. The goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children.
The investigators hypothesize that high relative to low energy density food images will be associated with increased activation in regions of the brain involved in reward- and sensory- processing and that large relative to small portion size food images will be associated with increased activation in regions of the brain involved in cognitive control. In addition, the investigators hypothesize that these brain responses will influence the relationship between portion size served and energy intake at laboratory meals.
Detailed description
What this study will add to the literature: The response to food images that vary by portion size using fMRI has not been previously reported. Furthermore, how the brain response to food portion size and energy density is related to energy intake has not been previously reported. The goal of this study is to identify brain regions activated in response to portion size and energy density and relate these neural responses to laboratory eating behaviors in children.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between the ages of 7-10 years old and their parents
Key inclusion criteria (5 listed)
- Right-handedness
- English as native language
- Reading at /above grade level
- Not claustrophobic
- Generally healthy
Key exclusion criteria (6 listed)
- Left-handedness
- Metal in or on the body that cannot be removed
- Claustrophobic
- Medication usage that could alter brain activity
- Medical disorder that may impact comfort in scanner
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
fMRI blood oxygen level dependent (BOLD) response to food portion size and energy density
Time frame: Collected at fMRI scan (1 of 1) at week 5
Whole-brain response to food images that varied at 2 levels of portion size and 2 levels of energy density
Energy intake
Time frame: Collected at week 1, 2, 3, and 4
Energy intake (kcal and grams) of foods consumed ad libitum at each laboratory test-meal in response to 4 conditions of portion sizes (100% reference, 133%, 167%, 200%).
1 secondary outcome
Region of Interest (ROI)-response to food portion size and energy density
Time frame: Collected at fMRI scan (1 of 1) at week 5
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 17 Dec 2020.
- Background: PubMed 25447010English L, Lasschuijt M, Keller KL. Mechanisms of the portion size effect. What is known and where do we go from here? Appetite. 2015 May;88:39-49. doi: 10.1016/j.appet.2014.11.004. Epub 2014 Nov 11.
- Results publication: PubMed 26973134Fearnbach SN, English LK, Lasschuijt M, Wilson SJ, Savage JS, Fisher JO, Rolls BJ, Keller KL. Brain response to images of food varying in energy density is associated with body composition in 7- to 10-year-old children: Results of an exploratory study. Physiol Behav. 2016 Aug 1;162:3-9. doi: 10.1016/j.physbeh.2016.03.007. Epub 2016 Mar 10.
- 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 35883226Diktas HE, Keller KL, Roe LS, Rolls BJ. Children's Portion Selection Is Predicted by Food Liking and Is Related to Intake in Response to Increased Portions. J Nutr. 2022 Oct 6;152(10):2287-2296. doi: 10.1093/jn/nxac162.
- Derived from this study: PubMed 29408590Keller KL, English LK, Fearnbach SN, Lasschuijt M, Anderson K, Bermudez M, Fisher JO, Rolls BJ, Wilson SJ. Brain response to food cues varying in portion size is associated with individual differences in the portion size effect in children. Appetite. 2018 Jun 1;125:139-151. doi: 10.1016/j.appet.2018.01.027. Epub 2018 Feb 2.
- Individual participant dataSharing planned: Undecided
Related trials for Pediatric Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingPhase 3
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
Obesity
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
RecruitingPhase 3
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Obesity, Overweight
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 Keller, PhD principal investigator
The Pennsylvania State University
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity, run by Penn State University.
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 5 inclusion and 6 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
fMRI blood oxygen level dependent (BOLD) response to food portion size and energy density (time frame: Collected at fMRI scan (1 of 1) at week 5). The study lists 2 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 NCT02759523, which also lists 5 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 17 Dec 2020.