- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05010798
Quality of Life in Binge Eating Disorder.
Quality of Life in Binge Eating Disorder: Danish Language Disease Specific Measures.
Study Overview
Status
Conditions
Detailed Description
Eating disorders (ED's) are a group of disorders characterized by abnormal eating behaviors ranging from insufficient to excessive food intake, with concurrent disturbances in thoughts and emotions. Binge Eating Disorder (BED) is the most prevalent ED in both men and women, yet was only recently included in the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) as a diagnostic entity.
In general, ED's have been associated with significantly worse health related quality of life (HRQoL) compared to healthy population.
High rates of overweight (BMI ≥ 25) and obesity (BMI ≥ 30) are found in BED patients and obesity in itself is associated with lower QoL. The most widely used tools to measure Qol in ED's are the Medical Outcome Studies Short Form (SF) Scale, e.g. SF-36 and SF-12, which are generic in nature. Generic QoL measures have shown lack of sensitivity for some ED diagnoses and might not be suitable enough to pick up unique features that might characterize each disorder.
The objective of this study is to evaluate quality of life in Danish BED patients before treatment by using disease specific Qol measure. Furthermore, we want to assess the impact of obesity and depression on disease specific Qol in BED patients. The hypothesis are that obesity and depression will be associated with an impaired level of disease specific Qol.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Odense, Denmark, 5000
- Center for Eating Disorders, Odense University Hospital
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Odense, Denmark, DK-5000
- Department of Endocrinology, Odense University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
1. Patients referred to treatment for BED at Center f. Eating Disorders, OUH.
Exclusion Criteria:
- Extremely severe BED.
- Severe psychiatric comorbidity.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Disorder Quality of Life Questionnaire (EDQLS)
Time Frame: Approximately 2 years
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Disease specific quality of life measure. The EDQLS consists of 40 items across 12 subscales and takes 2-11 minutes (mean 5 minutes) to complete. Each item is rated on a five-point Likert scale from 'strongly disagree' (scored as 1) to 'strongly agree' (scored as 5), with a higher score indicating better HRQoL (minimum score 40; maximum score 200). The 12 subscales are: cognitive, education/vocation, family and close relationships, relationships with others, future outlook, appearance, leisure, psychological, emotional, values and beliefs, physical, and eating. Each subscale contains three items, except for the 'eating' subscale which has six items. The EDQLS software includes an automatic scoring program that converts all item responses to a total score (some subscales require reverse scoring prior to summing). |
Approximately 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: René K Støving, PhD, Odense UH
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QoL BED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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