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NCT Number: NCT05726721

Profiling the Dynamic of Binge Eating Disorder (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.

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Key information

Conditions

Binge-Eating Disorder Behavior Behavior, Animal Behavioral Symptoms Depression Depressive Symptoms Eating Behavior Emotion Regulation Emotional Regulation Executive Dysfunction Feeding Behavior Feeding and Eating Disorders Mental Disorders Self-Control Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Psychiaty, Aarhus, Central Jutland, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Treatment as usual, Psychotherapy

Other

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

Primary outcomes

  1. Subgroups of BED-profiles

    Time frame: Baseline data

    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 .

  2. Binge eating episodes EoT

    Time frame: At end of therapy up to 30 weeks

    Number of binge eating episodes

  3. Binge eating episodes FU6m

    Time frame: At 6-month follow-up

    Number of binge eating episodes

  4. Binge eating episodes FU12m

    Time frame: At 12-month follow-up

    Number of binge eating episodes

Secondary outcomes

  1. Eating disorder pathology

    Time frame: At end of treatment up to 30 weeks

    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

  2. Eating disorder pathology

    Time frame: At 6-month follow-up

    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

  3. Eating disorder pathology

    Time frame: At 12-month follow-up

    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

  4. Functional impairment

    Time frame: At end of treatment up to 30 weeks

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

  5. Functional impairment

    Time frame: At 6-month follow-up

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

  6. Functional impairment

    Time frame: At 12-month follow-up

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

  7. Well-being

    Time frame: At end of treatment up to 30 weeks

    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

  8. Well-being

    Time frame: At 6-month follow-up

    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

  9. Well-being

    Time frame: At 12-month follow-up

    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

  10. Trajectories of binge eating

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

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

  11. Trajectories of restrictive eating

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

    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

  12. Trajectories of emotional eating

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

    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

  13. Trajectories of eating on external cues

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

    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

  14. Trajectories of grazing

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

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

  15. Trajectories of emotional regulation

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

    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

  16. Trajectories of executive function

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

    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

  17. Trajectories of depression

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Loa Clausen, PhD

CONTACT

[email protected]

+4529119734

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Kompetencecenter for Spiseforstyrrelser

Registry information

Official study 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)

Acronym: PRODY-BED

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Feb 14, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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