Working Memory in Overweight Children With and Without Loss of Control Eating

Pediatric Obesity Clinical Trial

Official title:

Neural Substrates of Context-dependent Working Memory in Youth With Overweight/Obesity and Loss of Control Eating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117542
• Other study ID #: 1205595
• Status: Completed
• Start date: October 18, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Bulimia
• Obesity
• Overweight
• Pediatric Obesity

Intervention

Other:
• Observational
Observational data will be obtained through participant self-response, parental response, cognitive performance, and neural imaging.

Locations

Country	Name	City	State
United States	Weight Control & Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	Body Mass Index calculated with height/weight (cm/g)	1 day
Primary	Eating Behavior	Eating behavior will be assessed using the Eating Disorders Examination (EDE), a semi-structured interview.	1 day
Primary	Neural Activity	Neural activation will be assessed using functional magnetic resonance imaging (fMRI) data	Up to 2 weeks
Primary	Working Memory	Working memory will be assessed using the NIH Toolbox list sort task.	1 day