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Emotion Regulation and Binge Eating in Youth With Obesity

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ClinicalTrials.gov Identifier: NCT02783872
Recruitment Status : Unknown
Verified August 2017 by The Miriam Hospital.
Recruitment status was:  Recruiting
First Posted : May 26, 2016
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
The Miriam Hospital

Brief Summary:
This study will investigate neural activation patterns in emotion- and cognition-related brain regions during an emotion regulation task involving cognitive reappraisal, and their associations with age and pubertal status, among overweight children and adolescents with loss of control eating as compared to overweight and normal-weight controls.

Condition or disease
Obesity Binge-Eating Disorder

Detailed Description:
Loss of control (LOC) while eating (i.e., the sense that one cannot control what or how much one is eating) is prevalent among children and adolescents. LOC eating is associated with a range of physical and psychosocial health impairments, including obesity and the development of partial- and full-syndrome eating disorders. Early identification is thus critical for preventing or minimizing these adverse health outcomes. However, little is known about the development of LOC eating in children and, consequently, there is a paucity of effective interventions. Impairments in emotion regulation appear to be involved in the onset and maintenance of eating pathology in obese samples. To date, emotion regulation in youth with LOC eating problems is poorly understood, and research on underlying neurodevelopmental substrates is virtually nonexistent. The proposed research aims to characterize neurocircuitry involved in emotion regulation among 30 overweight children with LOC eating as compared to 30 overweight and 15 normal-weight controls without LOC. Participants will complete a cognitive reappraisal task whilst situated in an MRI scanner, the purpose of which is to characterize neural activity involved in reappraisal versus an emotion maintenance control condition. The proposed research aims to advance the field's understanding of the nature and correlates of LOC eating in overweight children so as to inform intervention development.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Neurodevelopmental Substrates of Emotion Regulation in Overweight, Binge Eating Youth
Actual Study Start Date : November 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Group/Cohort
Loss of control
30 overweight or obese (BMI≥85th %ile) youth endorsing loss of control eating within the past 3 months
Overweight control
30 overweight or obese controls without any history of loss of control eating
Normal-weight control
15 normal-weight controls without any history of loss of control eating



Primary Outcome Measures :
  1. Patterns of activation in cognitive control and emotion-related regions of the brain [ Time Frame: Baseline ]
    Activity in cognitive control regions of the brain (i.e., dorsal anterior cingulate cortex, and dorsolateral, dorsomedial, and ventrolateral prefrontal cortices) and emotion-related regions of the brain (i.e., amygdala, insula, and ventral striatum) during emotion regulation relative to emotion maintenance



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
75 right-handed age- and gender-matched youth, aged 10-17 years
Criteria

Inclusion Criteria:

  • Right-handed, aged 10-17 years.

Exclusion Criteria:

Participants will be excluded if they

  • are currently taking any medications known to affect mood or weight (e.g., antidepressants, steroids);
  • have a current diagnosis of a mood disorder or an eating disorder involving purging or suppressed body weight (e.g., bulimia nervosa or anorexia nervosa);
  • are unable to read and understand English fluently;
  • are currently pregnant;
  • are a current smoker; or
  • have metallic foreign bodies, face or neck tattoos, or other conditions that would prohibit fMRI scanning. Participants will complete a mock scan (see below) to ensure that their head and trunk size can be comfortably accommodated in the scanner.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783872


Contacts
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Contact: Caroline West 401-793-8283 Caroline.West@Lifespan.org

Locations
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United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Caroline West    401-793-8283    Caroline.West@Lifespan.org   
Sponsors and Collaborators
The Miriam Hospital
Investigators
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Principal Investigator: Andrea B Goldschmidt, Ph.D. The Miriam Hospital

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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT02783872     History of Changes
Other Study ID Numbers: Miriam H
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Obesity
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Nutrition Disorders
Mental Disorders
Hyperphagia
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive