ObesityNCT02783872
Emotion Regulation and Binge Eating in Youth With Obesity
An observational study of Obesity and Binge-Eating Disorder, run by The Miriam Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Binge-Eating Disorder
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 75 right-handed age- and gender-matched youth, aged 10-17 years
Who may be able to join
- Right-handed, aged 10-17 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Binge-Eating Disorder
- Medical subject headings
- Obesity, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea B Goldschmidt, Ph.D., Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783872
- Sponsor's protocol ID
- Miriam H
- Status last verified
- Aug 2020
- First submitted
- 20 May 2016
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Substrates of Emotion Regulation in Overweight, Binge Eating Youth
- ClinicalTrials.gov ID
- NCT02783872
- Acronym / sponsor ID
- Miriam H
- Conditions
- Obesity, Binge-Eating Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 75 right-handed age- and gender-matched youth, aged 10-17 years
Key inclusion criteria (1 listed)
- Right-handed, aged 10-17 years.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea B Goldschmidt, Ph.D. principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Binge-Eating Disorder, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patterns of activation in cognitive control and emotion-related regions of the brain (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.