Emotion Regulation and Binge Eating in Youth With Obesity
Neurodevelopmental Substrates of Emotion Regulation in Overweight, Binge Eating Youth
1 other identifier
observational
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2016
Typical duration for all trials
1 active site
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
First Submitted
Initial submission to the registry
May 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFebruary 23, 2021
August 1, 2020
3.5 years
May 20, 2016
February 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Patterns of activation in cognitive control and emotion-related regions of the brain
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
Baseline
Study Arms (3)
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
Eligibility Criteria
75 right-handed age- and gender-matched youth, aged 10-17 years
You may qualify if:
- Right-handed, aged 10-17 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Miriam Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea B Goldschmidt, Ph.D.
The Miriam Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
May 26, 2016
Study Start
November 1, 2016
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
February 23, 2021
Record last verified: 2020-08