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Improving Weight Loss Outcomes for Binge Eating Disorder.

Primary Purpose

Eating Disorder, Binge-Eating Disorder, Weight Loss

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance-Based Behavioral Weight Loss Therapy for BED
Standard Behavior Therapy
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder focused on measuring Eating Disorder, Binge Eating, Binge Eating Disorder, Weight Loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Drexel University, Stratton Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABBT Weight Loss Therapy for BED

Standard Behavior Therapy

Arm Description

Acceptance-Based Behavioral Weight Loss Therapy for BED

Standard Behavioral Weight Loss Therapy

Outcomes

Primary Outcome Measures

Weight Loss
Between-group changes in percent weight loss throughout the course of the study and at the one year follow-up assessment

Secondary Outcome Measures

Eating Disorder Examination Questionnaire
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.

Full Information

First Posted
October 17, 2018
Last Updated
September 21, 2023
Sponsor
Drexel University
Collaborators
Yale University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03712462
Brief Title
Improving Weight Loss Outcomes for Binge Eating Disorder.
Official Title
Improving Weight Loss Outcomes for Binge Eating Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University
Collaborators
Yale University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder, Binge-Eating Disorder, Weight Loss, Binge Eating
Keywords
Eating Disorder, Binge Eating, Binge Eating Disorder, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The novel acceptance-based behavioral weight loss therapy is being compared to standard behavioral weight loss therapy for individuals with binge eating disorder.
Masking
Participant
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABBT Weight Loss Therapy for BED
Arm Type
Experimental
Arm Description
Acceptance-Based Behavioral Weight Loss Therapy for BED
Arm Title
Standard Behavior Therapy
Arm Type
Active Comparator
Arm Description
Standard Behavioral Weight Loss Therapy
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-Based Behavioral Weight Loss Therapy for BED
Intervention Description
ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.
Intervention Type
Behavioral
Intervention Name(s)
Standard Behavior Therapy
Intervention Description
SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.
Primary Outcome Measure Information:
Title
Weight Loss
Description
Between-group changes in percent weight loss throughout the course of the study and at the one year follow-up assessment
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)
Secondary Outcome Measure Information:
Title
Eating Disorder Examination Questionnaire
Description
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.
Time Frame
Changes from each assessment time point throughout treatment (5 assessments over 1 year) and 1 year post-treatment follow-up assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Drexel University, Stratton Hall
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Links:
URL
https://drexel.edu/coas/academics/departments-centers/well-center/research/current-research-projects/
Description
For more information on the study or whether you are eligible, send an email to EDresearch@drexel.edu.

Learn more about this trial

Improving Weight Loss Outcomes for Binge Eating Disorder.

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