- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04117542
Working Memory in Overweight Children With and Without Loss of Control Eating
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:
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Weight Control & Diabetes Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Overweight/Obese (>85% expected body mass)
- Right-handed
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Overweight/Obesity Control
Adolescents who have overweight/obesity, but do not report loss of control eating.
|
Observational data will be obtained through participant self-response, parental response, cognitive performance, and neural imaging.
|
|
Overweight/Obesity Experimental
Adolescents who have overweight/obesity, and report loss of control eating.
|
Observational data will be obtained through participant self-response, parental response, cognitive performance, and neural imaging.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BMI
Time Frame: 1 day
|
Body Mass Index calculated with height/weight (cm/g)
|
1 day
|
|
Eating Behavior
Time Frame: 1 day
|
Eating behavior will be assessed using the Eating Disorders Examination (EDE), a semi-structured interview.
|
1 day
|
|
Neural Activity
Time Frame: Up to 2 weeks
|
Neural activation will be assessed using functional magnetic resonance imaging (fMRI) data
|
Up to 2 weeks
|
|
Working Memory
Time Frame: 1 day
|
Working memory will be assessed using the NIH Toolbox list sort task.
|
1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrea B. Goldschmidt, Ph.D., Warren Alpert Medical School of Brown University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1205595
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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