Improving Weight Loss Outcomes for Binge Eating Disorder.

September 21, 2023 updated by: Drexel University
This study aims to develop and evaluate the efficacy of a behavioral weight loss treatment approach for individuals with binge eating disorder to both reduce their binge eating behaviors and lose weight.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Drexel University, Stratton Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meet the DSM-5 criteria for Binge Eating Disorder
  • Have a BMI range of 27-50kg/m2

Exclusion Criteria:

  • are unable to fluently speak, write, and read English
  • are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., suicidality, substance use disorder, psychotic disorder)
  • are unable to engage in moderate physical activity (i.e., walk 2 blocks without rest)
  • have a medical condition (e.g., acute coronary syndrome, type I diabetes) that would pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the recommendations of the program
  • Pregnant or planning to become pregnant in the next 2 years
  • Recently began a course of or changed the dosage of medication that can cause significant change in weight
  • Have a history of bariatric surgery
  • Have had weight loss of > 5% in the past 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBT Weight Loss Therapy for BED
Acceptance-Based Behavioral Weight Loss Therapy for BED
ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.
Active Comparator: Standard Behavior Therapy
Standard Behavioral Weight Loss Therapy
SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: Changes from baseline assessment (before beginning treatment), to post-treatment assessment (1 year after baseline assessment), to follow-up assessment (2 years after baseline assessment)
Between-group changes in percent weight loss throughout the course of the study and at the one year follow-up assessment
Changes from baseline assessment (before beginning treatment), to post-treatment assessment (1 year after baseline assessment), to follow-up assessment (2 years after baseline assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Disorder Examination Questionnaire
Time Frame: Changes from each assessment time point throughout treatment (5 assessments over 1 year) and 1 year post-treatment follow-up assessment

The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE-Q will be used to assess utilization of skills related to reducing dietary restraint.

Assessing changes in EDE Global score and frequency of objective binge episodes.

Changes from each assessment time point throughout treatment (5 assessments over 1 year) and 1 year post-treatment follow-up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2018

Primary Completion (Actual)

August 1, 2023

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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