Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2020
Source The Miriam Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
United States The Miriam Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2