Pediatric ObesityNCT02788838
The Impact of Food Advertisements on Brain Response and Eating Behavior in Children
An observational study of Pediatric Obesity, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this project is to examine the impact that television food advertisements have on brain responses and eating behavior in children. Food advertisements enhance children's liking and intake of foods that tend to be high in energy content and low in nutritional value. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to May 2017
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children ages 7-9 years old
Who may be able to join
- Right-handed
- English as native language
- Reading at/above grade level
- Not Claustrophobic
- Generally Healthy
Who cannot join
- Left-handedness
- Metal in or on body that cannot be removed
- Claustrophobic
- Medication usage that may alter brain activity or blood flow
- Medical disorder that may impact comfort or safety in MRI scanner
- Food allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
The purpose of this project is to examine the impact that television food advertisements have on brain responses and eating behavior in children. Food advertisements enhance children's liking and intake of foods that tend to be high in energy content and low in nutritional value. Although several studies have measured the differences in children's food intake after watching advertisements, none have shown the brain mechanisms associated with this change in behavior. In order to clarify the relationship between food advertising and eating behavior, the investigators have assembled a team with expertise in functional imaging, eating behaviors, and clinical pediatric research. First, the investigators will observe the differences in children's eating behaviors after being exposed to food commercials or non-food commercials. Second, the investigators will measure the difference in child brain response to high and low energy foods after being exposed to food commercials or non-food commercials. These data will allow us to identify which areas of the brain are specifically affected by exposure to food commercials and correlate activity in these areas with children's measured food intake in the laboratory. Children ages 7-9 will participate in this 5-visit study which will be completed over the course of 12 months. Understanding how food advertisements impact children's brain responses and subsequent eating behaviors will have implications for understanding why some children respond differently to these cues than others. These outcomes may also inform the development of more effective programs and policies to prevent childhood obesity.
- Conditions
- Pediatric Obesity
- Keywords
- Magnetic Resonance Imaging, Energy Intake, Commercials, Children
- Medical subject headings
- Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional magnetic resonance imaging (fMRI), blood oxygen level dependent (BOLD) response to high and low energy foods following food commercial priming
Whole-brain response to food images varied by 2 levels of energy viewed in 2 conditions
Measured: Collected at fMRI scan at week 4 or 5 (randomized)
Functional magnetic resonance imaging, blood oxygen level dependent (BOLD) response to high and low energy foods following toy commercial priming
Energy intake of foods consumed ad libitum at each laboratory test-meal in 3 conditions
Measured: Collected at fMRI scan at week 4 or 5 (randomized)
Baseline Energy Intake
Energy intake of foods consumed ad libitum at laboratory test-meal with no priming stimulus
Measured: Collected at week 1 of the study
Energy Intake following food commercials
Energy intake of foods consumed ad libitum at laboratory test-meal following food commercials priming
Measured: Collected at week 2 or 3 (randomized) of the study
Energy Intake following toy commercials
Energy intake of foods consumed ad libitum at laboratory test-meal following toy priming stimulus
Measured: Collected at week 2 or 3 (randomized) of the study
Secondary outcomes (1)
Region of Interest (ROI)-response to food type by condition
Response in selected regions of interest to images varied by 2 levels of energy viewed in 2 conditions
Measured: Collected at fMRI scans at weeks 4 and 5 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 88 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788838
- Sponsor's protocol ID
- CommercialEating01
- Status last verified
- Jan 2021
- First submitted
- 24 May 2016
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Food Advertisements on Brain Response and Eating Behavior in Children
- ClinicalTrials.gov ID
- NCT02788838
- Acronym / sponsor ID
- CommercialEating01
- Conditions
- Pediatric Obesity
- Keywords
- Magnetic Resonance Imaging, Energy Intake, Commercials, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Jun 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.
The purpose of this project is to examine the impact that television food advertisements have on brain responses and eating behavior in children. Food advertisements enhance children's liking and intake of foods that tend to be high in energy content and low in nutritional value. Although several studies have measured the differences in children's food intake after watching advertisements, none have shown the brain mechanisms associated with this change in behavior. In order to clarify the relationship between food advertising and eating behavior, the investigators have assembled a team with expertise in functional imaging, eating behaviors, and clinical pediatric research. First, the investigators will observe the differences in children's eating behaviors after being exposed to food commercials or non-food commercials. Second, the investigators will measure the difference in child brain response to high and low energy foods after being exposed to food commercials or non-food commercials. These data will allow us to identify which areas of the brain are specifically affected by exposure to food commercials and correlate activity in these areas with children's measured food intake in the laboratory. Children ages 7-9 will participate in this 5-visit study which will be completed over the course of 12 months. Understanding how food advertisements impact children's brain responses and subsequent eating behaviors will have implications for understanding why some children respond differently to these cues than others. These outcomes may also inform the development of more effective programs and policies to prevent childhood obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children ages 7-9 years old
Key inclusion criteria (5 listed)
- Right-handed
- English as native language
- Reading at/above grade level
- Not Claustrophobic
- Generally Healthy
Key exclusion criteria (6 listed)
- Left-handedness
- Metal in or on body that cannot be removed
- Claustrophobic
- Medication usage that may alter brain activity or blood flow
- Medical disorder that may impact comfort or safety in MRI 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
Functional magnetic resonance imaging (fMRI), blood oxygen level dependent (BOLD) response to high and low energy foods following food commercial priming
Time frame: Collected at fMRI scan at week 4 or 5 (randomized)
Whole-brain response to food images varied by 2 levels of energy viewed in 2 conditions
Functional magnetic resonance imaging, blood oxygen level dependent (BOLD) response to high and low energy foods following toy commercial priming
Time frame: Collected at fMRI scan at week 4 or 5 (randomized)
Energy intake of foods consumed ad libitum at each laboratory test-meal in 3 conditions
Baseline Energy Intake
Time frame: Collected at week 1 of the study
Energy intake of foods consumed ad libitum at laboratory test-meal with no priming stimulus
Energy Intake following food commercials
Time frame: Collected at week 2 or 3 (randomized) of the study
Energy intake of foods consumed ad libitum at laboratory test-meal following food commercials priming
Energy Intake following toy commercials
Time frame: Collected at week 2 or 3 (randomized) of the study
Energy intake of foods consumed ad libitum at laboratory test-meal following toy priming stimulus
1 secondary outcome
Region of Interest (ROI)-response to food type by condition
Time frame: Collected at fMRI scans at weeks 4 and 5 of study
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 13 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 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 13 Jan 2021. 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?
Functional magnetic resonance imaging (fMRI), blood oxygen level dependent (BOLD) response to high and low energy foods following food commercial priming (time frame: Collected at fMRI scan at week 4 or 5 (randomized)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2021.