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Clinical Trials/NCT06050616
NCT06050616
Completed
N/A

Multimodal Longitudinal and Machine Learning-based Predictive Modelling to Understand the Development of Eating Disorders

King's College London1 site in 1 country23 target enrollmentNovember 15, 2023

Overview

Phase
N/A
Intervention
MRI scans
Conditions
Binge-Eating Disorder
Sponsor
King's College London
Enrollment
23
Locations
1
Primary Endpoint
Eating disorder diagnosis
Status
Completed
Last Updated
last year

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
November 15, 2023
End Date
August 12, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zuo Zhang

Principal Investigator

King's College London

Eligibility Criteria

Inclusion Criteria

  • Male and female volunteers, all ethnicities.
  • Age of 18 to
  • Sufficient in English (due to validity of neuropsychological measures).
  • current DSM-5 binge eating disorder.

Exclusion Criteria

  • 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.
  • 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.

Arms & Interventions

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.

Intervention: MRI scans

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.

Intervention: Psychological measures

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.

Intervention: Life experiences

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.

Intervention: Blood and urine samples

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.

Intervention: 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.

Intervention: MRI scans

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.

Intervention: Psychological measures

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.

Intervention: Life experiences

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.

Intervention: Blood and urine samples

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.

Intervention: 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.

Intervention: MRI scans

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.

Intervention: Psychological measures

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.

Intervention: Life experiences

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.

Intervention: Blood and urine samples

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.

Intervention: 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.

Intervention: MRI scans

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.

Intervention: Psychological measures

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.

Intervention: Life experiences

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.

Intervention: Blood and urine samples

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.

Intervention: Mental health symptoms

Outcomes

Primary Outcomes

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.

Study Sites (1)

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