Binge-Eating DisorderESTRA-BEDNCT06050616
Multimodal Longitudinal and Predictive Modelling to Understand Eating Disorder Development
An observational study of Binge-Eating Disorder and Anorexia Nervosa, run by King's College London at 1 site in United Kingdom.
Trial summary
The aim of this observational study is to elucidate the biopsychosocial (including neural, psychological, and social) basis of eating disorders (EDs). The investigators will use functional and structural neuroimaging, psychological as well as environmental data to identify both shared and distinct behavioural/neural… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Binge-Eating Disorder, Anorexia Nervosa, Bulimia Nervosa
- What is being tested?
- MRI scans, Psychological measures and Life experiences
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2023to 12 Aug 2024
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants will be recruited via online and physical posters among people living in or near London, UK, and from eating disorder clinics in London.
Who may be able to join
- Male and female volunteers, all ethnicities.
- Age of 18 to 30.
- Sufficient in English (due to validity of neuropsychological measures).
- current DSM-5 binge eating disorder.
Who cannot join
- People with brain injuries including stroke, tumours, epilepsy, neurodegenerative or other neurological disorders.
- People who are deaf or have significant hearing problems or a hearing aid that cannot be removed.
- People who are blind or have significant vision difficulties (correct near vision of 20/100 or worse in both eyes).
- People with type I or type II diabetes.
- People who are heavily medicated for serious illness (other than for mental illness).
- People who are pregnant or any possibility of being pregnant.
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- People with restricted mobility, including inability to lie flat for 1.5 hours.
- People who have a history of anorexia nervosa and have not restored their body weight in the past 6 months.
- People who have participated in the STRATIFY, ESTRA or IMAGEN studies previously.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Psychiatry, Psychology & Neuroscience, King's College London
London, SE5 8AF
About this study
Official title: Multimodal Longitudinal and Machine Learning-based Predictive Modelling to Understand the Development of Eating Disorders
The aim of this observational study is to elucidate the biopsychosocial (including neural, psychological, and social) basis of eating disorders (EDs).
The investigators will use functional and structural neuroimaging, psychological as well as environmental data to identify both shared and distinct behavioural/neural processes across ED diagnoses. The investigators will use advanced statistical methods such as machine learning based models.
Read more
The investigators will carry out analysis on the data already collected in the STRATIFY (Brain network based stratification of reinforcement-related disorders, IRAS ID 218030) and IMAGEN studies (Reinforcement-related behaviour in normal brain function and psychopathology, reference PNM/10/11-126), including participants with Anorexia Nervosa (N=60), Bulimia Nervosa (N=52), Binge eating disorder (N=27) and healthy controls. In addition, the investigators will recruit 30 new participants with a binge eating disorder using the original STRATIFY study protocol to enlarge the binge eating disorder group, so that its sample size is comparable to the other groups.
Participants will complete online questionnaires, take an online clinical interview, and undergo a research visit, including brain scans, collection of blood and urine samples, and assessment using a range of cognitive and behavioural measures.
Read the detailed description
Eating disorders (EDs) are serious mental illnesses that involve a range of disturbed emotions, cognitions, and behaviours related to body shape/weight and eating. The causes of EDs are complex and involve many biological, psychological, and social factors. The investigators are interested in understanding the connections between a range of biological, psychological, social factors and eating disorders. This will help us understand the basis of diagnostic classifications, which will promote early intervention and the identification of new areas to target in treatments.
The investigators will analyse the data already collected in the STRATIFY (Brain network based stratification of reinforcement-related disorders, IRAS ID 218030) and IMAGEN studies (Reinforcement-related behaviour in normal brain function and psychopathology, reference PNM/10/11-126), including patients with Anorexia Nervosa (N=60), Bulimia Nervosa (N=52), Binge eating disorder (N=27) and healthy controls. In addition, the investigators will recruit 30 new participants with a current binge eating disorder using the original STRATIFY protocol to enlarge the binge eating disorder group, so that its sample size is comparable to the other groups. Due to funding limitations, 18 participants will take part in the full assessments, including the research visit (MRI scans, blood, and urine samples). The other 12 participants will take part in the online parts of the assessments only, without the research visit.
The investigators will use neuroimaging, cognitive, psychological and life events data to assess if behavioural/neural processes differentiate one eating disorder from another and if there are similar processes across ED diagnoses. The investigators will use advanced statistical methods such as machine learning based models.
The investigators will further test whether the identified behavioural and neurological processes can predict future disease risk, by using data from the IMAGEN study - a longitudinal population-based genetic and imaging study - that involves over 2000 participants followed up from adolescence to early adulthood.
- Conditions
- Binge-Eating Disorder, Anorexia Nervosa, Bulimia Nervosa
- Being tested
- MRI scans, Psychological measures, Life experiences, Blood and urine samples, Mental health symptoms
- Keywords
- Eating Disorders, Binge-Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Neuroimaging
- Medical subject headings
- Binge-Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scansOther
Neuroimaging data will be collected with magnetic resonance imaging (MRI).
Structural neuroimaging will include T1 and T2-weighted scans, and diffusion tensor imaging (DTI).
Functional neuroimaging will include scans under the stop-signal task, monetary incentive delay task, and emotional faces task, and resting state.
Psychological measuresOther
Cognitive performance assessed by Wechsler Adult Intelligence Scale 4th Edition.
Personalities assessed by NEO Five-Factor Inventory (NEO-FFI), Substance Use Risk Profile Scale (SURPS), and Temperament and Character Inventory (TCI).
Other psychological assessments include Interpersonal Reactivity Index, Perceived Stress Scale, Kirby Monetary Choice Questionnaire, Passive Avoidance Learning Paradigm, and Stimulus-response compatibility.
Life experiencesOther
Self-report questionnaires on experiences of bullying and trauma.
Blood and urine samplesBiological
Blood and urine samples will be collected but will not undergo analysis in this study. Instead, these samples will be stored in a biobank for potential analysis in future research.
Mental health symptomsOther
Symptoms of depression measured by the Patient Health Questionnaire -8.
Symptoms of generalised anxiety, obsessives compulsive disorder, attention deficit hyperactivity disorder, social phobia, specific phobia, agoraphobia, post-traumatic stress disorder, measured by the Development and Well-Being Assessment (DAWBA).
Harmful drinking measured by the Alcohol use disorders identification test.
Drug use measured by the European School Survey Project on Alcohol and Other Drugs (ESPAD).
Suicide risk measured by the the Mini International Neuropsychiatric Interview.
| Study group | Role | What they receive |
|---|---|---|
| binge eating disorder | Participants with a current binge eating disorder, as assessed by the Eating Disorder Diagnostic Screen (DSM-5 version). These participants have been recruited as part of the STRATIFY study. An additional 30 participants will be recruited in this study to enlarge the sample size, using the same study procedure and assessments in the STRATIFY study. Receives: Other: MRI scans; Other: Psychological measures; Other: Life experiences; Biological: Blood and urine samples; Other: Mental health symptoms | |
| anorexia nervosa | Participants with current anorexia nervosa, as assessed by the Eating Disorder Diagnostic Screen (DSM-5 version).. These participants have been recruited as part of the STRATIFY study. Their data will be used in this study. Receives: Other: MRI scans; Other: Psychological measures; Other: Life experiences; Biological: Blood and urine samples; Other: Mental health symptoms | |
| bulimia nervosa | Participants with current bulimia nervosa, as assessed by the Eating Disorder Diagnostic Screen (DSM-5 version). These participants have been recruited as part of the STRATIFY study. Their data will be used in this study. Receives: Other: MRI scans; Other: Psychological measures; Other: Life experiences; Biological: Blood and urine samples; Other: Mental health symptoms | |
| healthy controls | Healthy controls are selected from the IMAGEN study at the third follow-up (~age 22 years) who do not exhibit any psychiatric disorder. Their data will be used in this study. IMAGEN and STRATIFY are sister studies that employ matched study protocols. Receives: Other: MRI scans; Other: Psychological measures; Other: Life experiences; Biological: Blood and urine samples; Other: Mental health symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating disorder diagnosis
The Eating Disorder Diagnostic Scale (DSM-5 version) will be used to assess whether the participants meet the diagnostic criteria of anorexia nervosa, bulimia nervosa, or binge eating disorder.
Measured: Administered at the screening phase and within two weeks of the other assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start15 Nov 2023
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Delosis Limited, NeuroSpin
- Responsible party
- Principal investigator, Zuo Zhang, King's College London
- Investigators
- Zuo Zhang, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050616
- Sponsor's protocol ID
- IRAS326571
- Other IDs
- MRF-058-0014-F-ZHAN-C0866, 23/NW/0232
- Acronym
- ESTRA-BED
- Status last verified
- Dec 2024
- First submitted
- 6 Sep 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data are to be shared. Data will be pseudonymised before sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Longitudinal and Machine Learning-based Predictive Modelling to Understand the Development of Eating Disorders
- ClinicalTrials.gov ID
- NCT06050616
- Acronym / sponsor ID
- ESTRA-BED / IRAS326571
- Conditions
- Binge-Eating Disorder, Anorexia Nervosa, Bulimia Nervosa
- Keywords
- Eating Disorders, Binge-Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Neuroimaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Delosis Limited, NeuroSpin
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- 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.
The aim of this observational study is to elucidate the biopsychosocial (including neural, psychological, and social) basis of eating disorders (EDs).
The investigators will use functional and structural neuroimaging, psychological as well as environmental data to identify both shared and distinct behavioural/neural processes across ED diagnoses. The investigators will use advanced statistical methods such as machine learning based models.
The investigators will carry out analysis on the data already collected in the STRATIFY (Brain network based stratification of reinforcement-related disorders, IRAS ID 218030) and IMAGEN studies (Reinforcement-related behaviour in normal brain function and psychopathology, reference PNM/10/11-126), including participants with Anorexia Nervosa (N=60), Bulimia Nervosa (N=52), Binge eating disorder (N=27) and healthy controls. In addition, the investigators will recruit 30 new participants with a binge eating disorder using the original STRATIFY study protocol to enlarge the binge eating disorder group, so that its sample size is comparable to the other groups.
Participants will complete online questionnaires, take an online clinical interview, and undergo a research visit, including brain scans, collection of blood and urine samples, and assessment using a range of cognitive and behavioural measures.
Detailed description
Eating disorders (EDs) are serious mental illnesses that involve a range of disturbed emotions, cognitions, and behaviours related to body shape/weight and eating. The causes of EDs are complex and involve many biological, psychological, and social factors. The investigators are interested in understanding the connections between a range of biological, psychological, social factors and eating disorders. This will help us understand the basis of diagnostic classifications, which will promote early intervention and the identification of new areas to target in treatments.
The investigators will analyse the data already collected in the STRATIFY (Brain network based stratification of reinforcement-related disorders, IRAS ID 218030) and IMAGEN studies (Reinforcement-related behaviour in normal brain function and psychopathology, reference PNM/10/11-126), including patients with Anorexia Nervosa (N=60), Bulimia Nervosa (N=52), Binge eating disorder (N=27) and healthy controls. In addition, the investigators will recruit 30 new participants with a current binge eating disorder using the original STRATIFY protocol to enlarge the binge eating disorder group, so that its sample size is comparable to the other groups. Due to funding limitations, 18 participants will take part in the full assessments, including the research visit (MRI scans, blood, and urine samples). The other 12 participants will take part in the online parts of the assessments only, without the research visit.
The investigators will use neuroimaging, cognitive, psychological and life events data to assess if behavioural/neural processes differentiate one eating disorder from another and if there are similar processes across ED diagnoses. The investigators will use advanced statistical methods such as machine learning based models.
The investigators will further test whether the identified behavioural and neurological processes can predict future disease risk, by using data from the IMAGEN study - a longitudinal population-based genetic and imaging study - that involves over 2000 participants followed up from adolescence to early adulthood.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| binge eating disorder | – | Other: MRI scans, Other: Psychological measures, Other: Life experiences, Biological: Blood and urine samples, Other: Mental health symptomsParticipants with a current binge eating disorder, as assessed by the Eating Disorder Diagnostic Screen (DSM-5 version). These participants have been recruited as part of the STRATIFY study. An additional 30 participants will be recruited in this study to enlarge the sample size, using the same study procedure and assessments in the STRATIFY study. |
| anorexia nervosa | – | Other: MRI scans, Other: Psychological measures, Other: Life experiences, Biological: Blood and urine samples, Other: Mental health symptomsParticipants with current anorexia nervosa, as assessed by the Eating Disorder Diagnostic Screen (DSM-5 version).. These participants have been recruited as part of the STRATIFY study. Their data will be used in this study. |
| bulimia nervosa | – | Other: MRI scans, Other: Psychological measures, Other: Life experiences, Biological: Blood and urine samples, Other: Mental health symptomsParticipants with current bulimia nervosa, as assessed by the Eating Disorder Diagnostic Screen (DSM-5 version). These participants have been recruited as part of the STRATIFY study. Their data will be used in this study. |
| healthy controls | – | Other: MRI scans, Other: Psychological measures, Other: Life experiences, Biological: Blood and urine samples, Other: Mental health symptomsHealthy controls are selected from the IMAGEN study at the third follow-up (~age 22 years) who do not exhibit any psychiatric disorder. Their data will be used in this study. IMAGEN and STRATIFY are sister studies that employ matched study protocols. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be recruited via online and physical posters among people living in or near London, UK, and from eating disorder clinics in London.
Key inclusion criteria (4 listed)
- Male and female volunteers, all ethnicities.
- Age of 18 to 30.
- Sufficient in English (due to validity of neuropsychological measures).
- current DSM-5 binge eating disorder.
Key exclusion criteria (9 listed)
- People with brain injuries including stroke, tumours, epilepsy, neurodegenerative or other neurological disorders.
- People who are deaf or have significant hearing problems or a hearing aid that cannot be removed.
- People who are blind or have significant vision difficulties (correct near vision of 20/100 or worse in both eyes).
- People with type I or type II diabetes.
- People who are heavily medicated for serious illness (other than for mental illness).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scansNeuroimaging data will be collected with magnetic resonance imaging (MRI). Structural neuroimaging will include T1 and T2-weighted scans, and diffusion tensor imaging (DTI). Functional neuroimaging will include scans under the stop-signal task, monetary incentive delay task, and emotional faces task, and resting state. | Other | anorexia nervosa, binge eating disorder, bulimia nervosa, healthy controls |
| Psychological measuresCognitive performance assessed by Wechsler Adult Intelligence Scale 4th Edition. Personalities assessed by NEO Five-Factor Inventory (NEO-FFI), Substance Use Risk Profile Scale (SURPS), and Temperament and Character Inventory (TCI). Other psychological assessments include Interpersonal Reactivity Index, Perceived Stress Scale, Kirby Monetary Choice Questionnaire, Passive Avoidance Learning Paradigm, and Stimulus-response compatibility. | Other | anorexia nervosa, binge eating disorder, bulimia nervosa, healthy controls |
| Life experiencesSelf-report questionnaires on experiences of bullying and trauma. | Other | anorexia nervosa, binge eating disorder, bulimia nervosa, healthy controls |
| Blood and urine samplesBlood and urine samples will be collected but will not undergo analysis in this study. Instead, these samples will be stored in a biobank for potential analysis in future research. | Biological | anorexia nervosa, binge eating disorder, bulimia nervosa, healthy controls |
| Mental health symptomsSymptoms of depression measured by the Patient Health Questionnaire -8. Symptoms of generalised anxiety, obsessives compulsive disorder, attention deficit hyperactivity disorder, social phobia, specific phobia, agoraphobia, post-traumatic stress disorder, measured by the Development and Well-Being Assessment (DAWBA). Harmful drinking measured by the Alcohol use disorders identification test. Drug use measured by the European School Survey Project on Alcohol and Other Drugs (ESPAD). Suicide risk measured by the the Mini International Neuropsychiatric Interview. | Other | anorexia nervosa, binge eating disorder, bulimia nervosa, healthy controls |
Primary outcome
Eating disorder diagnosis
Time frame: Administered at the screening phase and within two weeks of the other assessments.
The Eating Disorder Diagnostic Scale (DSM-5 version) will be used to assess whether the participants meet the diagnostic criteria of anorexia nervosa, bulimia nervosa, or binge eating disorder.
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 11 Dec 2024.
- Individual participant dataSharing planned: Yes. All collected individual participant data are to be shared. Data will be pseudonymised before sharing.
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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.
Zuo Zhang, PhD principal investigator
King's College London
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 Binge-Eating Disorder and Anorexia Nervosa, run by King's College London at 1 site in United Kingdom.
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 4 inclusion and 9 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 11 Dec 2024. 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 Kingdom. 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?
Eating disorder diagnosis (time frame: Administered at the screening phase and within two weeks of the other assessments.). 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 11 Dec 2024.