NCT06537895

Brief Summary

UK Eating Disorder services are facing unprecedented demand, with effective service delivery hampered by inadequate resources, fragmented services and variable care pathways. Individuals with eating disorders, families and clinicians all agree on the critical need to improve care pathways and treatment, leading to better outcomes. Eating disorders are serious, complex conditions influenced by a blend of biological, psychological, and environmental factors. The approach of this project is grounded in the "biopsychosocial" model. Recently, anorexia research confirms a genetic component, with biological, metabolic, and psychological mechanisms at play. Further biological research across eating disorders could allow a better understanding of the mechanisms underlying eating disorder development and better, more personalised treatments. This project will test the feasibility of establishing a UK-wide NHS research network spanning child and adult eating disorder services to enable a step change in the ability to conduct eating disorder research. It will help address fragmentation and facilitate novel biological, psychological, and social research collaborations. The data the investigators gather will be open to all researchers for data analyses, and the collaborations established will form a collaborative network to enable future clinical trials, experimental medicine and psychology. The study will be conducted at child and adult eating disorder services who opt to join the Network. Participants will be patients receiving treatment for an eating disorder at one of the participating services, and their parents/guardians if applicable. Participants will complete questionnaires and have blood and other physical tests as specified in the EDCRN dataset. The study will last until 29th October 2026 (the end of the current funding period) and/or when a participant is discharged from treatment, whichever is sooner. For participants discharged before the study ends, there will be an opportunity for patients to complete optional follow-up questionnaires on a periodic basis.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Oct 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2024Oct 2026

First Submitted

Initial submission to the registry

July 23, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2026

Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

July 23, 2024

Last Update Submit

August 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • EDCRN dataset

    The existence of a well-described dataset (maintained by at \>50% eating disorder services across the UK) of eating disorder presentation, treatment, outcomes, demographics, social risk factors, and blood test results which can be accessed (with appropriate permissions) by researchers and others for the purposes of addressing novel research questions and facilitating service improvement efforts. The EDCRN dataset comprises the following parameters: * ED Behaviours/cognitions * Depression * Anxiety * Autism * OCD * Perfectionism * Emotional regulation * Psychosocial impairment * Adverse experiences * Self-injurious behaviour * Food insecurity * Physical/somatic symptoms * ADHD * Alcohol use * PTSD symptoms * Self-administered comorbidity * Weight stigma * Treatment experience * Comorbidities * Caregiver impact * Weight history * Muscle power * Endocrine function * Liver function * Cardiac function * Electrolytes * Bone health * Demographics

    29th October 2026

Secondary Outcomes (3)

  • Data on treatment effects

    29th October 2026

  • Genetic Biomarkers

    29th October 2026

  • Socio-economic influences

    29th October 2026

Interventions

Participants will complete questionnaires and have blood and other physical tests as specified in the EDCRN dataset.

Eligibility Criteria

Age8 Years - 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population are individuals who are receiving treatment for an eating disorder(s) at a UK-based eating disorder service which is part of the EDCRN and (if desired by the patient and caregiver) their parents/guardians.

You may qualify if:

  • Patients who have been diagnosed with an eating disorder under at least 1 of the criteria specified in the DSM-5 and/or ICD-9, 10 or 11.
  • Patients who are receiving treatment as inpatients, day-patients or outpatients at a CAMHS or Adult service who is participating in the EDCRN.
  • Patients who are receiving treatment in the UK.
  • OR:
  • Parents/guardians of patients who have been diagnosed with an eating disorder under at least 1 of the criteria specified in the DSM-5 and/or ICD-9, 10 or 11.
  • Parents/guardians of patients who are receiving treatment as inpatients, day-patients or outpatients at a CAMHS or Adult service who is participating in the EDCRN.
  • Parents/guardians of patients who are receiving treatment in the UK.

You may not qualify if:

  • Individuals who do not meet the criteria specified above will be considered ineligible to participate in the EDCRN.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Gerome Breen, PhD

    King's College London (KCL)

    PRINCIPAL INVESTIGATOR
  • Karina Allen, PhD

    South London and Maudsley NHS Foundation Trust (SLaM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2024

First Posted

August 5, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 29, 2026

Study Completion (Estimated)

October 29, 2026

Last Updated

August 5, 2024

Record last verified: 2024-07