NCT04117542

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 23, 2021

Status Verified

October 1, 2019

Enrollment Period

2.2 years

First QC Date

October 2, 2019

Last Update Submit

February 22, 2021

Conditions

Keywords

Loss of Control EatingWorking Memory

Outcome Measures

Primary Outcomes (4)

  • BMI

    Body Mass Index calculated with height/weight (cm/g)

    1 day

  • Eating Behavior

    Eating behavior will be assessed using the Eating Disorders Examination (EDE), a semi-structured interview.

    1 day

  • Neural Activity

    Neural activation will be assessed using functional magnetic resonance imaging (fMRI) data

    Up to 2 weeks

  • Working Memory

    Working memory will be assessed using the NIH Toolbox list sort task.

    1 day

Study Arms (2)

Overweight/Obesity Control

Adolescents who have overweight/obesity, but do not report loss of control eating.

Other: Observational

Overweight/Obesity Experimental

Adolescents who have overweight/obesity, and report loss of control eating.

Other: Observational

Interventions

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

Overweight/Obesity ControlOverweight/Obesity Experimental

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Overweight/Obese (\>85% expected body mass)
  • Right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

BulimiaPediatric Obesity

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

HyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Andrea B. Goldschmidt, Ph.D.

    Warren Alpert Medical School of Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 7, 2019

Study Start

October 18, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 23, 2021

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations