An observational study in Eating Disorders, sponsored by Mental Health Services in the Capital Region, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Mental Health Services in the Capital Region, Denmark · Observational
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.
The overall aim is to assess associations between patient characteristics and treatment response across the spectrum of eating disorders to identify, which patients benefit from family based treatment, and which patients possibly would need other kinds of treatment or more intensive care.
Research questions:
Studies on treatment effectiveness for EDNOS in children and adolescents are still lacking. Hence, an important research question of this study is whether family based treatment for EDNOS is effective and is perceived as helpful by patients and families?
In addition, the project will seek to answer the following:
645 studies on the registry are indexed under Feeding and Eating Disorders; 153 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 102 across 177 observational studies indexed under Feeding and Eating Disorders.
Browse Feeding and Eating Disorders studies →Mental Health Services in the Capital Region, Denmark is the lead sponsor of 49 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children and adolescents presenting for treatment for anorexia nervosa typica or atypica (ICD-10: F50.0 or F50.1)
Behavioral: Family-based treatment
Children and adolescents presenting for treatment for bulimia nervosa typica or atypica (ICD-10: F50.2 or F50.3)
Behavioral: Family-based treatment
Children and adolescents presenting for treatment for other eating disorders (ICD-10: F50.8)
Behavioral: Family-based treatment
Open-end family therapy ad modum The Maudsley model
Also known as: FBT
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 10 years after treatment completion
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2018 (actual). Primary completion is estimated for Dec 2035, 212 months after the start.
Of 61 non-industry observational studies under Feeding and Eating Disorders, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 95. This study's planned 212 months is above that.
Counting every sponsor, half of 64 studies reached it within 42 months; a quarter within 18 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Feeding and Eating Disorders →
Mental Health Services in the Capital Region, Denmark