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RecruitingNCT05726721PRODY-BEDUpdated Feb 6, 2025

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

An observational study in Binge-Eating Disorder, Emotion Regulation and Executive Dysfunction, sponsored by Aarhus University Hospital. Recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by Aarhus University Hospital · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Binge-Eating Disorder
  • Emotion Regulation
  • Executive Dysfunction
  • Eating Behavior
  • Depressive Symptoms

Keywords

  • psychotherapy
  • Adults
  • binge eating disorder
  • emotion regulation
  • executive function
03

In context

Binge-Eating Disorder

233 studies on the registry are indexed under Binge-Eating Disorder; 53 are open to participants now.

This study's planned enrollment of 180 is above the median of 118 across 35 observational studies indexed under Binge-Eating Disorder.

Browse Binge-Eating Disorder studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Severe psychiatric comorbidity (e.g. psychosis, severe developmental disorder, severe cogntive impairement)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No

Interventions

  • OtherTreatment as usual, Psychotherapy

    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

06

What researchers measure

Primary outcomes

  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 .

    Time frame: Baseline data

  2. Binge eating episodes EoT

    Number of binge eating episodes

    Time frame: At end of therapy up to 30 weeks

  3. Binge eating episodes FU6m

    Number of binge eating episodes

    Time frame: At 6-month follow-up

  4. Binge eating episodes FU12m

    Number of binge eating episodes

    Time frame: At 12-month follow-up

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: From baseline to 12-month follow-up

07

Study locations

2 of 3 sites recruiting
  • Aarhus University Hospital, Psychiaty
    Aarhus, Central Denmark Region 8200, Denmark
    Recruiting
  • Aalborg University Hospital
    Aalborg, 9000, Denmark
    Not yet recruiting
    • Gry Telléus, PhD · Contactgdkt@rn.dk · +4524816269
  • Kompetencecenter
    Copenhagen NV, 2400, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Due til Danish legislation individual participant data wil not be available to researchers outside the research group.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2023 (actual). Primary completion is estimated for Dec 2027, 53 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2022
First posted
Feb 14, 2023
StartActual
Jul 3, 2023
Primary completionEst.
Dec 30, 2027
CompletionEst.
May 31, 2028
Last update
Feb 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05726721
Collaborators
Aalborg University Hospital, Kompetencecenter for Spiseforstyrrelser
Responsible party
Loa Clausen (Senior Researcher, Aarhus University Hospital) — Principal investigator
First posted
Feb 14, 2023
Start date
Jul 3, 2023
Primary completion
Dec 30, 2027 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Feb 6, 2025

Study contacts

Loa Clausen, PhD
Contact
loaclaus@rm.dk
+4529119734
Loa Clausen, PhD
principal investigator · Aarhus University Hospital, Psychiatry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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