NCT05956366

Brief Summary

This research project aims to characterize a naturalistic cohort of children and adolescents with eating disorders in terms of biological, psychological and psychopathological features. Further, the project will examine the effectiveness of treatment, the determinants of treatment outcome and the course of treatment response for children and adolescents with eating disorders (ED), treated in a generic specialist child and adolescent mental health service. The first choice of treatment is outpatient family-based treatment (FBT), which has documented effect for anorexia nervosa and bulimia nervosa. However, a subgroup of young persons with eating disorders does not respond sufficiently to this treatment, and evidence concerning effective treatment for children and adolescents with atypical eating disorders is still lacking. Further, treatment effectiveness for children and adolescents in a Danish naturalistic setting has never been examined.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
141mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Apr 2018Dec 2037

Study Start

First participant enrolled

April 1, 2018

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2037

Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

17.8 years

First QC Date

February 2, 2023

Last Update Submit

April 2, 2024

Conditions

Eating Disorders

Keywords

eating disorders, adolescents

Outcome Measures

Primary Outcomes (10)

  • proportion of participants with weight normalisation

    at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters\*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents

    through treatment completion an average of 1 year

  • proportion of participants with weight normalisation

    at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters\*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents

    2.5 years after treatment completion

  • proportion of participants with weight normalisation

    at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters\*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents

    5 years after treatment completion

  • proportion of participants with weight normalisation

    at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters\*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents

    7.5 years after treatment completion

  • proportion of participants with weight normalisation

    at or above 95% of ideal BMI adjusted for age and gender, based on the individual´s prior growth trajectory. BMI is calculated as weight in kg/(height in meters\*height in meters), and percentage if ideal BMI adjusted for age and gender is based on published, standardized growth curves from Danish children and adolescents

    10 years after treatment completion

  • proportion of participants with absence of eating disordered behaviors

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

    through treatment completion an average of 1 year

  • proportion of participants with absence of eating disordered behaviors

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

    2.5 years after treatment completion

  • proportion of participants with absence of eating disordered behaviors

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

    5 years after treatment completion

  • proportion of participants with absence of eating disordered behaviors

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

    7.5 years after treatment completion

  • proportion of participants with absence of eating disordered behaviors

    absence for 4 weeks (according to diagnostic questions if Eating Disorder Examination (EDE).

    10 years after treatment completion

Study Arms (3)

Anorexia nervosa

Children and adolescents presenting for treatment for anorexia nervosa typica or atypica (ICD-10: F50.0 or F50.1)

Behavioral: Family-based treatment

Bulimia nervosa

Children and adolescents presenting for treatment for bulimia nervosa typica or atypica (ICD-10: F50.2 or F50.3)

Behavioral: Family-based treatment

Other eating disorders

Children and adolescents presenting for treatment for other eating disorders (ICD-10: F50.8)

Behavioral: Family-based treatment

Interventions

Family-based treatmentBEHAVIORAL

Open-end family therapy ad modum The Maudsley model

Also known as: FBT
Anorexia nervosaBulimia nervosaOther eating disorders

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All patients assessed and treated for any eating disorder (ICD-10: F50.0-F50.8) in the unit for treatment of eating disorders will be invited to participate. Due to the naturalistic design of this study we will examine a representative, consecutive sample, without any exclusion criteria except the absence of informed consent by patient and parents or legal care takers.

You may qualify if:

  • begin treatment for eating disorder

You may not qualify if:

  • lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Mental Health Care Center

Copenhagen, DK-2400, Denmark

RECRUITING

Related Publications (1)

  • Bentz M, Pedersen SH, Moslet U, Petersen N, Pagsberg AK. Predictors of response to family-based treatment for anorexia nervosa in youth: insights from the VIBUS project. Eur Child Adolesc Psychiatry. 2025 Nov;34(11):3665-3684. doi: 10.1007/s00787-025-02766-x. Epub 2025 Jun 11.

    PMID: 40498327DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mette Bentz, PhD

    Child and Adolescent Mental Health Care Centre, Capital Region of Denmark

    PRINCIPAL INVESTIGATOR

  • Anne Katrine Pagsberg, professor

    Child and Adolescent Mental Health Care Centre, Capital Region of Denmark

    STUDY DIRECTOR

Central Study Contacts

Mette Bentz, PhD

CONTACT

+45 38 64 10 35mette.bentz@regionh.dk

Study Design

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

Study Record Dates

First Submitted

February 2, 2023

First Posted

July 21, 2023

Study Start

April 1, 2018

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2037

Last Updated

April 3, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)