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Binge-Eating DisorderPRODY-BEDNCT05726721

Profiling the Dynamic of Binge Eating Disorder (PRODY-BED)

An observational study of Binge-Eating Disorder and Emotion Regulation, run by Aarhus University Hospital at 3 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to explore if different and specific profiles can be identified in adults with binge eating disorder (BED) depending on their additional eating pathology, emotion regulation and executive functions. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Treatment as usual, Psychotherapy
How many people
180 participants
Where
3 sitesDenmark
Study dates
3 Jul 2023to 31 May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 aged 18+ years diagnosed with BED, accepted for treatment at one of the three sites, and accepting participation.

Who may be able to join

  • Age 18+,
  • diagnosed with Binge eating Disorder,
  • and offered treatment at on of the inclusion sites.

Who cannot join

  • Severe psychiatric comorbidity (e.g. psychosis, severe developmental disorder, severe cogntive impairement)

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Loa Clausen, PhD contact

+4529119734

loaclaus@rm.dk

Denmark3 sites, 3 recruiting

  • Aalborg University Hospital

    Aalborg, 9000

    Gry Telléus, PhD, +4524816269, gdkt@rn.dk

    Not yet recruiting

  • Aarhus University Hospital, Psychiaty

    Aarhus, Central Jutland, 8200

    Loa Clausen, PhD, +4529119734, loaclaus@rm.dk

    Mette Bader, +4524828332, mette.bader@rm.dk

    Recruiting

  • Kompetencecenter

    Copenhagen NV, 2400

    Birgitte Schousboe, MSc, +4593908383, birgitte@kompetencecenter.nu

    Recruiting

Other trials in Denmark

About this study

Official title: Profiling the Dynamic of Binge Eating Disorder (BED): a Longitudinal Study Examining the Influence of Emotion Regulation, Executive Function, Eating Pattern on BED and Outcome (PRODY-BED)

The goal of this observational study is to explore if different and specific profiles can be identified in adults with binge eating disorder (BED) depending on their additional eating pathology, emotion regulation and executive functions. The main questions it aims to answer are:

  • Is there different and specific subgroups of patients with BED according to baseline profiles in emotion regulation, executive function and additional eating pathology (including restriction, chaotic eating, grazing and eating on external cues)?
  • Are subgroups of individuals with BED (based on identified profiles) associated with outcome at end of treatment and follow-up?
  • What is the trajectories in remission rates of specific symptom dimensions (eating disorder pathology, emotion regulation, executive function, and depressive symptoms) in individuals with BED and is there specific trajectory profiles in these dimensions?
  • Is early changes in specific symptom dimensions (eating pathology, emotion regulation, executive function, or depression) associated with outcome of BED? Participants will be asked to fill in questionnaires before treatment as usual, 10 weeks into treatment, at end of treatment and at 6- and 12-month follow-up.
Read the detailed description

Binge eating disorder (BED) is a severe eating disorder characterized by recurrent episodes of binge eating, where control over eating is lost and huge amounts of food are eaten within a short period of time. Hence, weight issues are often inevitable and overweight is common, as are social, mental as well as physical problems.

The etiology of binge eating disorder is an interplay of neurobiological and environmental factors. Overall pathological eating, including grazing, external, emotional or restrictive eating, is associated with binge eating, and so is dysregulation in the reward center, impairment of executive functions and emotion regulation. The investigators suggest that it is possible to identify specific profiles driving binge eating, depending on the severity of these dimensions, and that these profiles might predict the outcome of treatment. The investigators also suggest that early change in general eating pattern, emotion regulation, and depressive symptoms is associated with binge eating outcome. These assumptions will be tested in a sample of adults in treatment for BED at one of three sites using questionnaires before, during and after treatment, incl. 6- and 12-month follow-ups.

Being tested
Treatment as usual, Psychotherapy
Keywords
psychotherapy, Adults, binge eating disorder, emotion regulation, executive function
Medical subject headings
Binge-Eating Disorder, Emotional Regulation, Feeding Behavior, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment as usual, PsychotherapyOther

    The three treament sites will offer psychotherapy as usual. All including elements of cognitive behavioral therapy and some sites also additional elements from either narrative therapy or interpersonal therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subgroups of BED-profiles

    Subgroups of BED-profiles depending on degree and type of additional eating pathology measured by DEBQ (Dutch Eating Behaviour Questionnaire), emotion regulation problems measured by DERS-16 (Difficulties in Emotion Regulation Scale), and executive problems mesured by BRIEF-A .

    Measured: Baseline data

  2. Binge eating episodes EoT

    Number of binge eating episodes

    Measured: At end of therapy up to 30 weeks

  3. Binge eating episodes FU6m

    Number of binge eating episodes

    Measured: At 6-month follow-up

  4. Binge eating episodes FU12m

    Number of binge eating episodes

    Measured: At 12-month follow-up

Secondary outcomes (17)

  1. Eating disorder pathology

    Overall self-reported eating disorder pathology measured by the total score of Eating Disoder Examination Questionnaire (EDE-Q), minimum score 0, maximum score 6, higher scores indicating eating pathology

    Measured: At end of treatment up to 30 weeks

  2. Eating disorder pathology

    Overall self-reported eating disorder pathology measured by the total score of EDE-Q, minimum score 0, maximum score 6, higher scores indicating eating pathology

    Measured: At 6-month follow-up

  3. Eating disorder pathology

    Overall self-reported eating disorder pathology measured by the total score of EDE-Q, minimum score 0, maximum score 6, higher scores indicating eating pathology

    Measured: At 12-month follow-up

  4. Functional impairment

    Self-reported functional impairment measured by the total score of WSAS, minimum score 0, maximum score 8, higher scores indicating more impairment

    Measured: At end of treatment up to 30 weeks

  5. Functional impairment

    Self-reported functional impairment measured by the total score of WSAS, minimum score 0, maximum score 8, higher scores indicating more impairment

    Measured: At 6-month follow-up

  6. Functional impairment

    Self-reported functional impairment measured by the total scorer of WSAS, minimum score 0, maximum score 8, higher scores indicating more impairment

    Measured: At 12-month follow-up

  7. Well-being

    Self-reported well-being measured by the total score of WHO-5, minimum score 0, maximum score 25, with lower scores indicating worst imaginable well-bing

    Measured: At end of treatment up to 30 weeks

  8. Well-being

    Self-reported well-being measured by the total score of WHO-5, minimum score 0, maximum score 25, with lower scores indicating worst imaginable well-bing

    Measured: At 6-month follow-up

  9. Well-being

    Self-reported well-being measured by the total score of WHO-5, minimum score 0, maximum score 25, with lower scores indicating worst imaginable well-bing

    Measured: At 12-month follow-up

  10. Trajectories of binge eating

    Trajectories of frequency of binge eating across time measured by self-reported binge eating in Eating Disorder Examination questionnaire (EDE-Q)

    Measured: From baseline to 12-month follow-up

  11. Trajectories of restrictive eating

    Trajectories of restrictive eating across time measured by the DEBQ restraint eating scale, minum score 1, maximum score 5, higher scores indicating more restricted eating

    Measured: From baseline to 12-month follow-up

  12. Trajectories of emotional eating

    Trajectories of emotional eating across time measued by the DEBQ emotional eating scale, minimum score 1, maximum score 5, higher scores indicating more emotional eating

    Measured: From baseline to 12-month follow-up

  13. Trajectories of eating on external cues

    Trajectories of eating on external cues across time measured by the DEBQ external eating scale, minimum score 1, maximum score 5, higher scores indicating more eating on external cues

    Measured: From baseline to 12-month follow-up

  14. Trajectories of grazing

    Trajectories of grazing across time measured by the total score of the Grazing Questionnaire, minimum 0, maximum 28, higher scores indcating greater grazing behavior

    Measured: From baseline to 12-month follow-up

  15. Trajectories of emotional regulation

    Trajectories of emotional regulation across time measured by the total score of DERS-16, minimum score 16, maximum score 80, higher socres indicating greater diffuculties

    Measured: From baseline to 12-month follow-up

  16. Trajectories of executive function

    Trajectories of executive function across time measured by the BRIEF-A (Behavior rating inventory of Executive Function Adult version) Global Executive Composite T-Scores, minimum score 0, maximum score 90, higher scores indicating executive problems

    Measured: From baseline to 12-month follow-up

  17. Trajectories of depression

    Trajectories of depression across time measured by Beck Depression Inventory 2, minimum score 0, maximum score 63, higher scores indicating more depressive symptoms

    Measured: From baseline to 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start3 Jul 2023
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

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
Prospective
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726721
Sponsor's protocol ID
PRODY-BED
Acronym
PRODY-BED
Status last verified
Feb 2025
First submitted
15 Dec 2022
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due til Danish legislation individual participant data wil not be available to researchers outside the research group.

Questions about this trial

What is this clinical trial studying?

An observational study of Binge-Eating Disorder and Emotion Regulation, run by Aarhus University Hospital at 3 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Loa Clausen, PhD (+4529119734, loaclaus@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subgroups of BED-profiles (time frame: Baseline data). The study lists 4 primary outcomes in all. 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 NCT05726721.

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 2025.

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