Binge EatingNCT04117542
Working Memory in Overweight Children With and Without Loss of Control Eating
An observational study of Binge Eating and Pediatric Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Loss of control (LOC) eating in children is associated with multiple physical and mental health impairments, including obesity and eating disorders. Little is known about the developmental neurobiology of LOC, which is crucial to specifying its pathophysiology and the development of effective preventive interventions. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Binge Eating, Pediatric Obesity
- What is being tested?
- Observational
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2018to 31 Dec 2020
- 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 10 to 17 years
- All sexes
- Child
Study population: Participants will be 30 children, ages 10-17, 15 of whom who are overweight/obese and report loss of control eating (i.e., at least 3 objectively or subjectively large loss of control episodes in the past 3 months), and 15 of whom who will serve as overweight/obese controls.
Who may be able to join
- Overweight/Obese (>85% expected body mass)
- Right-handed
Who cannot join
- Currently taking any medications known to affect their weight/appetite
- Report current or past medical or psychiatric conditions known to significantly affect eating or weight (e.g., diabetes, bulimia nervosa), with the exception of binge eating disorder
- Have an intelligence quotient (IQ) in the borderline range or lower, or any condition affecting executive functioning (e.g., recent concussion, history of traumatic brain injury)
- Are unable to read or comprehend study materials
- Are receiving concurrent treatment for overweight/obesity
- Have metallic foreign bodies, face or neck tattoos, or other conditions that would prohibit fMRI scanning
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Neural Substrates of Context-dependent Working Memory in Youth With Overweight/Obesity and Loss of Control Eating
Loss of control (LOC) eating in children is associated with multiple physical and mental health impairments, including obesity and eating disorders. Little is known about the developmental neurobiology of LOC, which is crucial to specifying its pathophysiology and the development of effective preventive interventions. Individual differences in working memory (WM) appear to be related to LOC eating and excess weight status in youth, but the specificity and neural correlates of these individual differences are unclear. Failure to adequately understand the nature of associations between WM and eating behavior in children with overweight/obesity limits the development of appropriately-targeted, neuro-developmentally informed interventions addressing problematic eating and related weight gain in youth. To close this clinical research gap, the current study proposes to investigate the context-dependence of WM impairment and its neural correlates in children with concomitant overweight/ obesity and LOC eating as compared to their overweight/obese peers.
Specific aims are to investigate:
Read more
1)WM performance in youth with LOC eating relative to overweight/obese controls during recalls in the context of food-related versus neutral distractors; and 2) neural activation patterns during WM performance across both food-related and neutral stimuli. We hypothesize that, relative to their overweight/obese peers, youth with LOC eating will show 1) more errors and slower response times during recalls involving food-related vs. neutral distractors, and fewer errors and faster response times during recalls involving food-related vs. neutral targets; 2) increased activation in prefrontal regions during WM performance across stimuli types relative to overweight/obese controls, and 3) even greater activation in the context of food-related versus neutral distractors.
The proposed study is the first to use state-of-the-science neuroimaging methodology to clarify the relations between WM and LOC eating, with strong potential to advance understanding of the associations among executive functioning, excess weight status, and eating pathology, and inform the development of interventions (e.g., WM training) to alleviate their cumulative personal and societal burden.
- Conditions
- Binge Eating, Pediatric Obesity
- Being tested
- Observational
- Keywords
- Loss of Control Eating, Working Memory
- Medical subject headings
- Bulimia, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational data will be obtained through participant self-response, parental response, cognitive performance, and neural imaging.
| Study group | Role | What they receive |
|---|---|---|
| Overweight/Obesity Control | Adolescents who have overweight/obesity, but do not report loss of control eating. Receives: Other: Observational | |
| Overweight/Obesity Experimental | Adolescents who have overweight/obesity, and report loss of control eating. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Body Mass Index calculated with height/weight (cm/g)
Measured: 1 day
Eating Behavior
Eating behavior will be assessed using the Eating Disorders Examination (EDE), a semi-structured interview.
Measured: 1 day
Neural Activity
Neural activation will be assessed using functional magnetic resonance imaging (fMRI) data
Measured: Up to 2 weeks
Working Memory
Working memory will be assessed using the NIH Toolbox list sort task.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start18 Oct 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Sponsor
- Investigators
- Andrea B. Goldschmidt, Ph.D., Principal investigator, Warren Alpert Medical School of Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117542
- Sponsor's protocol ID
- 1205595
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Substrates of Context-dependent Working Memory in Youth With Overweight/Obesity and Loss of Control Eating
- ClinicalTrials.gov ID
- NCT04117542
- Acronym / sponsor ID
- 1205595
- Conditions
- Binge Eating, Pediatric Obesity
- Keywords
- Loss of Control Eating, Working Memory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Oct 2019 (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.
Loss of control (LOC) eating in children is associated with multiple physical and mental health impairments, including obesity and eating disorders. Little is known about the developmental neurobiology of LOC, which is crucial to specifying its pathophysiology and the development of effective preventive interventions. Individual differences in working memory (WM) appear to be related to LOC eating and excess weight status in youth, but the specificity and neural correlates of these individual differences are unclear. Failure to adequately understand the nature of associations between WM and eating behavior in children with overweight/obesity limits the development of appropriately-targeted, neuro-developmentally informed interventions addressing problematic eating and related weight gain in youth. To close this clinical research gap, the current study proposes to investigate the context-dependence of WM impairment and its neural correlates in children with concomitant overweight/ obesity and LOC eating as compared to their overweight/obese peers.
Specific aims are to investigate:
1)WM performance in youth with LOC eating relative to overweight/obese controls during recalls in the context of food-related versus neutral distractors; and 2) neural activation patterns during WM performance across both food-related and neutral stimuli. We hypothesize that, relative to their overweight/obese peers, youth with LOC eating will show 1) more errors and slower response times during recalls involving food-related vs. neutral distractors, and fewer errors and faster response times during recalls involving food-related vs. neutral targets; 2) increased activation in prefrontal regions during WM performance across stimuli types relative to overweight/obese controls, and 3) even greater activation in the context of food-related versus neutral distractors.
The proposed study is the first to use state-of-the-science neuroimaging methodology to clarify the relations between WM and LOC eating, with strong potential to advance understanding of the associations among executive functioning, excess weight status, and eating pathology, and inform the development of interventions (e.g., WM training) to alleviate their cumulative personal and societal burden.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overweight/Obesity Control | – | Other: ObservationalAdolescents who have overweight/obesity, but do not report loss of control eating. |
| Overweight/Obesity Experimental | – | Other: ObservationalAdolescents who have overweight/obesity, and report loss of control eating. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Participants will be 30 children, ages 10-17, 15 of whom who are overweight/obese and report loss of control eating (i.e., at least 3 objectively or subjectively large loss of control episodes in the past 3 months), and 15 of whom who will serve as overweight/obese controls.
Key inclusion criteria (2 listed)
- Overweight/Obese (>85% expected body mass)
- Right-handed
Key exclusion criteria (6 listed)
- Currently taking any medications known to affect their weight/appetite
- Report current or past medical or psychiatric conditions known to significantly affect eating or weight (e.g., diabetes, bulimia nervosa), with the exception of binge eating disorder
- Have an intelligence quotient (IQ) in the borderline range or lower, or any condition affecting executive functioning (e.g., recent concussion, history of traumatic brain injury)
- Are unable to read or comprehend study materials
- Are receiving concurrent treatment for overweight/obesity
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 |
|---|---|---|
| ObservationalObservational data will be obtained through participant self-response, parental response, cognitive performance, and neural imaging. | Other | Overweight/Obesity Control, Overweight/Obesity Experimental |
Primary outcome
BMI
Time frame: 1 day
Body Mass Index calculated with height/weight (cm/g)
Eating Behavior
Time frame: 1 day
Eating behavior will be assessed using the Eating Disorders Examination (EDE), a semi-structured interview.
Neural Activity
Time frame: Up to 2 weeks
Neural activation will be assessed using functional magnetic resonance imaging (fMRI) data
Working Memory
Time frame: 1 day
Working memory will be assessed using the NIH Toolbox list sort task.
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 23 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Andrea B. Goldschmidt, Ph.D. principal investigator
Warren Alpert Medical School of Brown 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 Binge Eating and Pediatric Obesity, run by The Miriam Hospital 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 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 23 Feb 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?
BMI (time frame: 1 day). The study lists 4 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 23 Feb 2021.