NCT05010798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3.6 years

First QC Date

August 10, 2021

Last Update Submit

February 4, 2024

Conditions

Keywords

binge eating disordersQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Extremely severe BED.
  • Severe psychiatric comorbidity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for eating Disorders, Odense University Hospital

Odense, 5000, Denmark

Location

Department of Endocrinology, Odense University Hospital

Odense, DK-5000, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 33918786BACKGROUND
  • Gudmundsdottir S, Linnet J, Lichtenstein MB, Adair CE, Carlsson SD, Brandt L, Rasmussen J, Stoving RK. Low quality of life in binge eating disorder compared to healthy controls. Dan Med J. 2023 Mar 14;70(4):A07220443.

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • René K Støving, PhD

    Odense UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 18, 2021

Study Start

June 1, 2019

Primary Completion

January 1, 2023

Study Completion

October 1, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations