Pediatric ObesityNCT01908153
Taste Reward Processing in Pediatric Obesity
An observational study of Pediatric Obesity, run by Stanford University at 1 site in United States.
Trial summary
The study aims to provide a better understanding of the neural influence of eating behavior in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI brain response to pictures that signal delivery of a chocolate milkshake and to the taste itself. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Aug 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children ages 4-8
Who may be able to join
- ages 4-8
- parent available to complete surveys in English
Who cannot join
- no presence of metal in body
- no claustrophobia
- no psychiatric or neurological condition that will affect brain function
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Department of Psychiatry
Stanford, California, 94305
About this study
The study aims to provide a better understanding of the neural influence of eating behavior in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI brain response to pictures that signal delivery of a chocolate milkshake and to the taste itself. The brain response will be compared to body mass index percentile scores for each child to help us determine whether brain differences present in adolescents and adults with obesity are present in young children.
- Conditions
- Pediatric Obesity
- Keywords
- Picture food type, Taste type
- Medical subject headings
- Pediatric 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 |
|---|---|---|
| Overweight/Obese | Children with BMI percentile of 85 or above. | |
| Healthy Weight | Children with BMI percentile between 15 and 85. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI brain response to taste of chocolate milkshake
Measured: Baseline
fMRI brain response to picture cue
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Stanford 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
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Bohon, PhD, Stanford University
- Investigators
- Cara Bohon, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908153
- Sponsor's protocol ID
- UL1TR000093
- Status last verified
- Apr 2019
- First submitted
- 23 Jul 2013
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bohon C. Brain response to taste in overweight children: A pilot feasibility study. PLoS One. 2017 Feb 24;12(2):e0172604. doi: 10.1371/journal.pone.0172604. eCollection 2017.
PubMed 28235080
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste Reward Processing in Pediatric Obesity
- ClinicalTrials.gov ID
- NCT01908153
- Acronym / sponsor ID
- UL1TR000093
- Conditions
- Pediatric Obesity
- Keywords
- Picture food type, Taste type
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Jul 2013 (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 study aims to provide a better understanding of the neural influence of eating behavior in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI brain response to pictures that signal delivery of a chocolate milkshake and to the taste itself. The brain response will be compared to body mass index percentile scores for each child to help us determine whether brain differences present in adolescents and adults with obesity are present in young children.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overweight/Obese | – | –Children with BMI percentile of 85 or above. |
| Healthy Weight | – | –Children with BMI percentile between 15 and 85. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children ages 4-8
Key inclusion criteria (2 listed)
- ages 4-8
- parent available to complete surveys in English
Key exclusion criteria (3 listed)
- no presence of metal in body
- no claustrophobia
- no psychiatric or neurological condition that will affect brain function
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 brain response to taste of chocolate milkshake
Time frame: Baseline
fMRI brain response to picture cue
Time frame: Baseline
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 10 Apr 2019.
- Results publication: PubMed 28235080Bohon C. Brain response to taste in overweight children: A pilot feasibility study. PLoS One. 2017 Feb 24;12(2):e0172604. doi: 10.1371/journal.pone.0172604. eCollection 2017.
Related trials for Pediatric Obesity
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
Active, not recruitingObservational study
Investigating the Impact of Obesity on Pubertal Development in Girls
Obesity, Puberty
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.
Cara Bohon, PhD principal investigator
Stanford 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, run by Stanford 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 2 inclusion and 3 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 10 Apr 2019. 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?
fMRI brain response to taste of chocolate milkshake (time frame: Baseline). 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 NCT01908153, which also lists 1 linked publication.
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 10 Apr 2019.