- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02783872
Emotion Regulation and Binge Eating in Youth With Obesity
February 22, 2021 updated by: The Miriam Hospital
Neurodevelopmental Substrates of Emotion Regulation in Overweight, Binge Eating Youth
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02903
- The Miriam Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
75 right-handed age- and gender-matched youth, aged 10-17 years
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Loss of control
30 overweight or obese (BMI≥85th %ile) youth endorsing loss of control eating within the past 3 months
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Overweight control
30 overweight or obese controls without any history of loss of control eating
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Normal-weight control
15 normal-weight controls without any history of loss of control eating
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patterns of activation in cognitive control and emotion-related regions of the brain
Time Frame: Baseline
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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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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrea B Goldschmidt, Ph.D., The Miriam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
May 1, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
May 20, 2016
First Submitted That Met QC Criteria
May 23, 2016
First Posted (Estimate)
May 26, 2016
Study Record Updates
Last Update Posted (Actual)
February 23, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Miriam H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.