Binge-Eating DisorderNCT05010798
Quality of Life in Binge Eating Disorder.
An observational study of Binge-Eating Disorder and Quality of Life, run by Odense University Hospital at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge-Eating Disorder, Quality of Life
- How many people
- 98 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Jun 2019to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1. Patients referred to treatment for BED at Center f. Eating Disorders, OUH.
Who cannot join
- Extremely severe BED.
- Severe psychiatric comorbidity.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Center for eating Disorders, Odense University Hospital
Odense, 5000
Department of Endocrinology, Odense University Hospital
Odense, DK-5000
About this study
Official title: Quality of Life in Binge Eating Disorder: Danish Language Disease Specific Measures.
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.
Read the 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.
- Conditions
- Binge-Eating Disorder, Quality of Life
- Keywords
- binge eating disorders, Quality of life
- Medical subject headings
- Binge-Eating Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Jun 2019
- Primary completion1 Jan 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark
- Responsible party
- Principal investigator, René Klinkby Støving, Odense University Hospital
- Investigators
- René K Støving, PhD, Principal investigator, Odense UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010798
- Sponsor's protocol ID
- QoL BED
- Status last verified
- Feb 2024
- First submitted
- 10 Aug 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33918786Gudmundsdottir 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.
PubMed 36999814
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Binge Eating Disorder: Danish Language Disease Specific Measures.
- ClinicalTrials.gov ID
- NCT05010798
- Acronym / sponsor ID
- QoL BED
- Conditions
- Binge-Eating Disorder, Quality of Life
- Keywords
- binge eating disorders, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Region of Southern Denmark
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Patients referred to treatment for BED at Center f. Eating Disorders, OUH.
Key exclusion criteria (2 listed)
- Extremely severe BED.
- Severe psychiatric comorbidity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 33918786Winkler 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.
- Derived from this study: PubMed 36999814Gudmundsdottir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René K Støving, PhD principal investigator
Odense UH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Binge-Eating Disorder and Quality of Life, run by Odense University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Quality of Life Questionnaire (EDQLS) (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05010798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.