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

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.

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder; Depressive Symptoms; Executive Dysfunction; Emotion Regulation; Eating Behavior
• Intervention / Treatment: Other: Treatment as usual, Psychotherapy

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.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Loa Clausen, PhD; Phone Number: +4529119734; Email: loaclaus@rm.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Not yet recruiting
    • Aalborg University Hospital
    • Contact: Gry Telléus, PhD; Phone Number: +4524816269; Email: gdkt@rn.dk
  • Copenhagen NV, Denmark, 2400
    • Recruiting
    • Kompetencecenter
    • Contact: Birgitte Schousboe, MSc; Phone Number: +4593908383; Email: birgitte@kompetencecenter.nu
  • Selecteer Regio, Staat Of Provincie.
    • Aarhus, Selecteer Regio, Staat Of Provincie., Denmark, 8200
      • Recruiting
      • Aarhus University Hospital, Psychiaty
      • Contact: Loa Clausen, PhD; Phone Number: +4529119734; Email: loaclaus@rm.dk
      • Contact: Mette Bader; Phone Number: +4524828332; Email: mette.bader@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	Baseline data
Binge eating episodes EoT	Number of binge eating episodes	At end of therapy up to 30 weeks
Binge eating episodes FU6m	Number of binge eating episodes	At 6-month follow-up
Binge eating episodes FU12m	Number of binge eating episodes	At 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At end of treatment up to 30 weeks
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	At 6-month follow-up
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	At 12-month follow-up
Functional impairment	Self-reported functional impairment measured by the total score of WSAS, minimum score 0, maximum score 8, higher scores indicating more impairment	At end of treatment up to 30 weeks
Functional impairment	Self-reported functional impairment measured by the total score of WSAS, minimum score 0, maximum score 8, higher scores indicating more impairment	At 6-month follow-up
Functional impairment	Self-reported functional impairment measured by the total scorer of WSAS, minimum score 0, maximum score 8, higher scores indicating more impairment	At 12-month follow-up
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	At end of treatment up to 30 weeks
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	At 6-month follow-up
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	At 12-month follow-up
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)	From baseline to 12-month follow-up
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	From baseline to 12-month follow-up
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	From baseline to 12-month follow-up
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	From baseline to 12-month follow-up
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	From baseline to 12-month follow-up
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	From baseline to 12-month follow-up
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	From baseline to 12-month follow-up
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	From baseline to 12-month follow-up

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Aalborg University Hospital; Kompetencecenter for Spiseforstyrrelser
• Investigators: Principal Investigator: Loa Clausen, PhD, Aarhus University Hospital, Psychiatry

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Adults; psychotherapy; executive function; emotion regulation; binge eating disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Depression; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: PRODY-BED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due til Danish legislation individual participant data wil not be available to researchers outside the research group.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No