Quality of Life in Binge Eating Disorder.

Quality of Life Clinical Trial

Official title:

Quality of Life in Binge Eating Disorder: Danish Language Disease Specific Measures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010798
• Other study ID #: QoL BED
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2024
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Quality of Life

Locations

Country	Name	City	State
Denmark	Center for eating Disorders, Odense University Hospital	Odense
Denmark	Department of Endocrinology, Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Mental Health Services in the Region of Southern Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eating Disorder Quality of Life Questionnaire (EDQLS)	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