Obesity Clinical Trial
Official title:
Neurodevelopmental Substrates of Emotion Regulation in Overweight, Binge Eating Youth
NCT number | NCT02783872 |
Other study ID # | Miriam H |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | May 2020 |
Verified date | August 2020 |
Source | The Miriam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | May 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Miriam Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
The Miriam Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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