PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

NCT03224091 | Recruiting

• 1 other identifier: PCB-BCRED-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The PROLED study is a prospective and longitudinal study of patients with Eating Disorders. Annual interviews and collection of biological samples are done, as well as during changes in disease course e.g. during hospitalization. Included are qualitative interviews, psychometric tests, questionnaires which are used to collect data on psychopathology. There is also collection of blood, urine and faeces.

Conditions

Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Eating Disorder NOS

Keywords

Eating disorders; psychopathology; pathophysiology; prospective; longitudinal

Outcome Measures

Primary Outcomes (2)

• GAF-F total score

  Change in Global level of functioning will be assessed using the GAF-F score for the whole population of treated individuals

  through study completion, an average of 1 year

• BMI change over time

  Change in Body Mass Index (BMI) will be assess in the whole population of Anorexia Nervosa patients and compared to other diagnoses and Healthy controls, change over time

  through study completion, an average of 1 year

Secondary Outcomes (5)

• MDI

  through study completion, an average of 1 year

• cytokines in plasma

  through study completion, an average of 1 year

• Biomarkers in blood

  through study completion, an average of 1 year

• Total score on CogTrac

  through study completion, an average of 1 year

• Change in EDI

  through study completion, an average of 1 year

Study Arms (3)

Patients at Psychiatric Center Ballerup

Healthy Controls

Healthy Controls recovered from an eating disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at Psychiatric Center Ballerup with Eating Disorders

You may qualify if:

• Eating Disorder (ICD-10)

You may not qualify if:

• Forced care/non-voluntary

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• University of Southern Denmark: collaborator
• University of Copenhagen: collaborator
• Statens Serum Institut: collaborator

Study Sites (1)

Mental Health Center

Ballerup Municipality, Capitol Region, 2750, Denmark

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Louise Behrend_Rasmussen, MD,PhD

  Mental Health Center Ballerup

  STUDY CHAIR

Central Study Contacts

Magnus JC Sjögren, MD, PhD

CONTACT

+4538645157; jan.magnus.sjoegren@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor, Sr Consultant Psychiatrist

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: July 21, 2017
• Study Start: January 25, 2016
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

DK (1)