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OpenTrials
Completed

NCT Number: NCT05010798

Quality of Life in Binge Eating Disorder.

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.

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Key information

Conditions

Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders Quality of Life

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for eating Disorders, Odense University Hospital, Odense, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Extremely severe BED.
  • Severe psychiatric comorbidity.

Treatment and study plan

Primary outcomes

  1. Eating Disorder Quality of Life Questionnaire (EDQLS)

    Time frame: Approximately 2 years

    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).

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Region of Southern Denmark
  • University of Southern Denmark

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2021
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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