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

NCT ID: NCT05726721

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-03

Study Completion Date

2028-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Treatment 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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role collaborator

Kompetencecenter for Spiseforstyrrelser

UNKNOWN

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Loa Clausen

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Loa Clausen, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital, Psychiatry

Locations

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Aarhus University Hospital, Psychiaty

Aarhus, Central Jutland, Denmark

Site Status RECRUITING

Aalborg University Hospital

Aalborg, , Denmark

Site Status NOT_YET_RECRUITING

Kompetencecenter

Copenhagen NV, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Loa Clausen, PhD

Role: CONTACT

+4529119734

Facility Contacts

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Loa Clausen, PhD

Role: primary

+4529119734

Mette Bader

Role: backup

+4524828332

Gry Telléus, PhD

Role: primary

+4524816269

Birgitte Schousboe, MSc

Role: primary

+4593908383

Other Identifiers

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PRODY-BED

Identifier Type: -

Identifier Source: org_study_id

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