Eating DisordersNCT05656859
Prevalence of Eating Disorder Symptomatology Among Outpatients Referred to Health Promotion from Somatic Hospital Departments
An observational study of Eating Disorders, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The Department of Health Promotion at Aalborg University Hospital gets patients referred from all the hospital's departments. The Department of Health Promotion offers lifestyle courses to aid preventing disease relapses and further comorbidities to patients referred to other ambulatory treatments at the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Single group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 136 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Sep 2022to 31 Dec 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: All patients referred to the Department of Health Promotion
Who may be able to join
- Patients referred to the Department of Health Promotion at Aalborg University Hospital, Denmark
Who cannot join
- Under age 18
- Not able to read and understand Danish
- Not able to recieve mail in the danish digital postbox, e-Boks
Trial locations and contacts
1 site in 1 country.
About this study
The Department of Health Promotion at Aalborg University Hospital gets patients referred from all the hospital's departments. The Department of Health Promotion offers lifestyle courses to aid preventing disease relapses and further comorbidities to patients referred to other ambulatory treatments at the hospital. For most patients this also includes weight loss, but the primary goal is lifestyle change regarding eating and exercise habits to improve overall health state. Since it is known that eating disorders commonly occurs in individuals seeking help for weight loss, and that the prevalence is larger than in the background population, we also suspect that eating disorders would commonly occur among patients referred to the Department of Health Promotion. Therefore, we aim to investigate the prevalence of eating disorders among patients referred to lifestyle courses at the Department of Health Promotion.
- Conditions
- Eating Disorders
- Being tested
- Single group
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single groupBehavioural
Survey
| Study group | Role | What they receive |
|---|---|---|
| Study group | Descriptive study Receives: Behavioral: Single group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination Questionnaire (EDE-Q)
The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-reported questionnaire adapted from the semi-structured interview Eating Disorder Examination (EDE) and designed to assess the range and severity of features associated with a diagnosis of eating disorder using 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and a global score.
The EDE-Q generates two types of data: frequency data on key behavioural features of eating disorders in terms of number of episodes of the behaviour, and subscale scores reflecting the severity of characteristics of eating disorders.
Higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes.
Measured: 10 minutes
Secondary outcomes (2)
Binge Eating Disorder Questionnaire (BED-Q)
The Binge Eating Disorder Questionnaire (BED-Q) is a 9-item self-reported questionnaire. Items are rated on a 5-point Likert-type rating scale. Scores range between 0-32 and higher scores denote more problematic binge eating disorder. A diagnostic score that determine patient is diagnosed with Binge Eating Disorder or not can be calculated. 1 item rated "yes" or "no and other items are used to calculated a diagnostic score.
Measured: 5 minutes
Grazing Questionnaire (GQ)
Grazing Questionnaire (GQ) is a 8-item self-reported questionnaire to measure behaviours and cognitions specific to grazing. Items are rated on a 5-point Likert-type rating scale where higher scores represent more grazing behaviours and cognitions. Scores are summes to form a total score (range: 0-32).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start6 Sep 2022
- Primary completion31 Mar 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Aalborg 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Christensen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656859
- Sponsor's protocol ID
- F2022-088
- Status last verified
- Sep 2024
- First submitted
- 6 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Eating Disorder Symptomatology Among Outpatients Referred to Health Promotion from Somatic Hospital Departments
- ClinicalTrials.gov ID
- NCT05656859
- Acronym / sponsor ID
- F2022-088
- Conditions
- Eating Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Dec 2022 (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.
The Department of Health Promotion at Aalborg University Hospital gets patients referred from all the hospital's departments. The Department of Health Promotion offers lifestyle courses to aid preventing disease relapses and further comorbidities to patients referred to other ambulatory treatments at the hospital. For most patients this also includes weight loss, but the primary goal is lifestyle change regarding eating and exercise habits to improve overall health state. Since it is known that eating disorders commonly occurs in individuals seeking help for weight loss, and that the prevalence is larger than in the background population, we also suspect that eating disorders would commonly occur among patients referred to the Department of Health Promotion. Therefore, we aim to investigate the prevalence of eating disorders among patients referred to lifestyle courses at the Department of Health Promotion.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Behavioral: Single groupDescriptive study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients referred to the Department of Health Promotion
Key inclusion criteria (1 listed)
- Patients referred to the Department of Health Promotion at Aalborg University Hospital, Denmark
Key exclusion criteria (3 listed)
- Under age 18
- Not able to read and understand Danish
- Not able to recieve mail in the danish digital postbox, e-Boks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single groupSurvey | Behavioural | Study group |
Primary outcome
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: 10 minutes
The Eating Disorder Examination Questionnaire (EDE-Q) is a 28-item self-reported questionnaire adapted from the semi-structured interview Eating Disorder Examination (EDE) and designed to assess the range and severity of features associated with a diagnosis of eating disorder using 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and a global score. The EDE-Q generates two types of data: frequency data on key behavioural features of eating disorders in terms of number of episodes of the behaviour, and subscale scores reflecting the severity of characteristics of eating disorders. Higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes.
2 secondary outcomes
Binge Eating Disorder Questionnaire (BED-Q)
Time frame: 5 minutes
Grazing Questionnaire (GQ)
Time frame: 5 minutes
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by Aalborg University Hospital at 1 site 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 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Examination Questionnaire (EDE-Q) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.