Clinical trial NCT05010798: Quality of Life in Binge Eating Disorder.
Official title: Quality of Life in Binge Eating Disorder: Danish Language Disease Specific Measures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binge-Eating Disorder
Quality of Life
Keywords: binge eating disorders
Quality of life
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Region of Southern Denmark
First posted: 2021-08-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to treatment for BED at Center f. Eating Disorders, OUH. This is a new and free treatment offer. The population is therefore not known in advance, but is expected to be quite heterogeneous.

Brief summary: Binge Eating Disorder (BED) patients tend to report low quality of life (Qol). However, research is limited. Most research on Qol in BED include generic measures, rather than disease specific. Obesity is prevalent in BED, but contradicting evidence exists on the influence of obesity in BED.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients referred to treatment for BED at Center f. Eating Disorders, OUH.

Exclusion Criteria:

1. Extremely severe BED.
2. Severe psychiatric comorbidity.

Primary outcomes:
measure: Eating Disorder Quality of Life Questionnaire (EDQLS)
timeFrame: Approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Center for eating Disorders, Odense University Hospital
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
Study officials:
affiliation: Odense UH
name: René K Støving, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winkler LA, Gudex C, Lichtenstein MB, Roder ME, Adair CE, Sjogren JM, Stoving RK. Explanatory Factors for Disease-Specific Health-Related Quality of Life in Women with Anorexia Nervosa. J Clin Med. 2021 Apr 9;10(8):1592. doi: 10.3390/jcm10081592.