OverweightChildLearnNCT03254576
Cue-Reward Learning and Weight Gain in Youth
An observational study of Overweight and Obesity, run by University of California, San Diego at 1 site in United States.
Trial summary
The objective of the study is to compare children at low risk for obesity (two healthy weight parents) to children at high risk for obesity (two overweight parents) in their response rate to food taste and in their rate of learning using fMRI. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Functional MRI
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 27 Dec 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy-weight children (5-75thBMI%) between the ages of 8 and 11 years old with either two over-weight parents (BMI>25) or two healthy-weight parents (BMI = 18-24.9)
Who may be able to join
- Healthy weight children between the ages of 8 and 11 Years
- BMI 5-75th percentile
- Child must be right-handed
- Child must be willing to participate in an fMRI scan
- Either two biological parents who are overweight/obese or no biological parents that are overweight/obese
- One biological parent willing to bring child to assessment visits
- Child and participating parent Fluent in English for speaking, reading, and writing
- Child must like cheese pizza and chocolate milkshake
Who cannot join
- Child overweight (BMI≥85th percentile)
- Child diagnoses of a serious chronic physical disease (e.g., diabetes) for which physician supervision of diet and exercise prescription are needed
- Child who is taking medications that may impact brain responses (can take kids who are stable on meds)
- Child with MRI contraindications (presence of metallic foreign object or device in body, piercings that cannot be removed, tattooed permanent makeup that contain metal, braces, head trauma, claustrophobia, use of Bigen permanent hair dye)
- Child with an active eating disorder (reported on EDE interview) or with first degree relative with Anorexia Nervosa or Bulimia Nervosa
- Cognitive impairment or disability determined through parent and child self-report measures, and parent reported child individual education plan
Show all 10Show fewer
- Vision problems uncorrectable with lenses
- Food allergies related to cheese pizza, chocolate milkshake, or the snack foods used in the study
- Menarche in female participants at time of enrollment
- Children scoring within the midpubertal range or higher based on the Pubertal Development Scale
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92093
About this study
The objective of the study is to compare children at low risk for obesity (two healthy weight parents) to children at high risk for obesity (two overweight parents) in their response rate to food taste and in their rate of learning using fMRI.
Read the detailed description
The primary aim of this project is to conduct an adequately powered study that compares children at low risk for obesity to children at high risk for obesity on their brain responses to food tastes during a pavlovian learning task. Seven assessment visits will be conducted at three separate time points; baseline, 1-year follow up, and 2-year follow up. Assessments will include anthropometry, interviews, computer tasks, questionnaires, and an fMRI scan. This program of research tests a novel hypothesis regarding overeating and the development of obesity in children, and could provide critical data on individual vulnerabilities to overeating for further research. Furthermore, this study could provide mechanisms for intervention with regards to cue-reward learning in children, to ultimately prevent obesity in youth.
- Conditions
- Overweight, Obesity
- Being tested
- Functional MRI
- Keywords
- Overweight, Obesity, Body Mass Index, Weight, Brain imaging, Child, Learning
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Children at high-risk for obesity | Healthy-weight children (5th-75thBMI%) with two overweight/obese parents (BMI>25) Receives: Other: Functional MRI | |
| Children at low-risk for obesity | Healthy-weight children (5th-75thBMI%) with two healthy-weight parents (BMI = 18-24.9) Receives: Other: Functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue-reward learning
Whether rate of the shift in BOLD response from food cue to neutral cue is different between high and low-risk children
Measured: Baseline only
Reward Sensitivity
Whether the BOLD response to food cue differs between high and low-risk children
Measured: Baseline only
Weight gain
Whether rate of cue reward and reward sensitivity predict weight gain
Measured: Change from baseline at an average of 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study startDec 2016
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kerri Boutelle, University of California, San Diego
- Investigators
- Kerri Boutelle, Ph.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254576
- Sponsor's protocol ID
- 161468
- Other IDs
- R01DK111106
- Acronym
- ChildLearn
- Status last verified
- Jan 2024
- First submitted
- 16 Aug 2017
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boutelle KN, Wierenga CE, Bischoff-Grethe A, Melrose AJ, Grenesko-Stevens E, Paulus MP, Kaye WH. Increased brain response to appetitive tastes in the insula and amygdala in obese compared with healthy weight children when sated. Int J Obes (Lond). 2015 Apr;39(4):620-8. doi: 10.1038/ijo.2014.206. Epub 2014 Dec 11.
PubMed 25582522Mestre ZL, Bischoff-Grethe A, Eichen DM, Wierenga CE, Strong D, Boutelle KN. Hippocampal atrophy and altered brain responses to pleasant tastes among obese compared with healthy weight children. Int J Obes (Lond). 2017 Oct;41(10):1496-1502. doi: 10.1038/ijo.2017.130. Epub 2017 Jun 2.
PubMed 28572588
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cue-Reward Learning and Weight Gain in Youth
- ClinicalTrials.gov ID
- NCT03254576
- Acronym / sponsor ID
- ChildLearn / 161468
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Body Mass Index, Weight, Brain imaging, Child, Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Study start
- Dec 2016 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 18 Aug 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 objective of the study is to compare children at low risk for obesity (two healthy weight parents) to children at high risk for obesity (two overweight parents) in their response rate to food taste and in their rate of learning using fMRI.
Detailed description
The primary aim of this project is to conduct an adequately powered study that compares children at low risk for obesity to children at high risk for obesity on their brain responses to food tastes during a pavlovian learning task. Seven assessment visits will be conducted at three separate time points; baseline, 1-year follow up, and 2-year follow up. Assessments will include anthropometry, interviews, computer tasks, questionnaires, and an fMRI scan. This program of research tests a novel hypothesis regarding overeating and the development of obesity in children, and could provide critical data on individual vulnerabilities to overeating for further research. Furthermore, this study could provide mechanisms for intervention with regards to cue-reward learning in children, to ultimately prevent obesity in youth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children at high-risk for obesity | – | Other: Functional MRIHealthy-weight children (5th-75thBMI%) with two overweight/obese parents (BMI>25) |
| Children at low-risk for obesity | – | Other: Functional MRIHealthy-weight children (5th-75thBMI%) with two healthy-weight parents (BMI = 18-24.9) |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy-weight children (5-75thBMI%) between the ages of 8 and 11 years old with either two over-weight parents (BMI>25) or two healthy-weight parents (BMI = 18-24.9)
Key inclusion criteria (8 listed)
- Healthy weight children between the ages of 8 and 11 Years
- BMI 5-75th percentile
- Child must be right-handed
- Child must be willing to participate in an fMRI scan
- Either two biological parents who are overweight/obese or no biological parents that are overweight/obese
Key exclusion criteria (10 listed)
- Child overweight (BMI≥85th percentile)
- Child diagnoses of a serious chronic physical disease (e.g., diabetes) for which physician supervision of diet and exercise prescription are needed
- Child who is taking medications that may impact brain responses (can take kids who are stable on meds)
- Child with MRI contraindications (presence of metallic foreign object or device in body, piercings that cannot be removed, tattooed permanent makeup that contain metal, braces, head trauma, claustrophobia, use of Bigen permanent hair dye)
- Child with an active eating disorder (reported on EDE interview) or with first degree relative with Anorexia Nervosa or Bulimia Nervosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRI | Other | Children at high-risk for obesity, Children at low-risk for obesity |
Primary outcome
Cue-reward learning
Time frame: Baseline only
Whether rate of the shift in BOLD response from food cue to neutral cue is different between high and low-risk children
Reward Sensitivity
Time frame: Baseline only
Whether the BOLD response to food cue differs between high and low-risk children
Weight gain
Time frame: Change from baseline at an average of 12 months and 24 months
Whether rate of cue reward and reward sensitivity predict weight gain
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 29 Jan 2024.
- Background: PubMed 25582522Boutelle KN, Wierenga CE, Bischoff-Grethe A, Melrose AJ, Grenesko-Stevens E, Paulus MP, Kaye WH. Increased brain response to appetitive tastes in the insula and amygdala in obese compared with healthy weight children when sated. Int J Obes (Lond). 2015 Apr;39(4):620-8. doi: 10.1038/ijo.2014.206. Epub 2014 Dec 11.
- Background: PubMed 28572588Mestre ZL, Bischoff-Grethe A, Eichen DM, Wierenga CE, Strong D, Boutelle KN. Hippocampal atrophy and altered brain responses to pleasant tastes among obese compared with healthy weight children. Int J Obes (Lond). 2017 Oct;41(10):1496-1502. doi: 10.1038/ijo.2017.130. Epub 2017 Jun 2.
- Individual participant dataSharing planned: Undecided
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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.
Kerri Boutelle, Ph.D. principal investigator
UCSD
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 Overweight and Obesity, run by University of California, San Diego 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 8 inclusion and 10 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 29 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?
Cue-reward learning (time frame: Baseline only). 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 NCT03254576, which also lists 2 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 29 Jan 2024.