Improving Weight Loss Outcomes for Binge Eating Disorder.

• ClinicalTrials.gov Identifier: NCT03712462
• Recruitment Status: Active, not recruiting
• First Posted: October 19, 2018
• Last Update Posted: September 23, 2021
• Sponsor: Drexel University
• Collaborators: Yale University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Drexel University

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.

Condition or disease	Intervention/treatment	Phase
Eating Disorder; Binge-Eating Disorder; Weight Loss; Binge Eating	Behavioral: Acceptance-Based Behavioral Weight Loss Therapy for BED; Behavioral: Standard Behavior Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Improving Weight Loss Outcomes for Binge Eating Disorder.
• Actual Study Start Date: August 20, 2018
• Estimated Primary Completion Date: January 30, 2023
• Estimated Study Completion Date: January 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: ABBT Weight Loss Therapy for BED; Acceptance-Based Behavioral Weight Loss Therapy for BED	Behavioral: 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	Behavioral: Standard Behavior Therapy; SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

Drexel University, Stratton Hall

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Drexel University

Yale University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

Additional Information:

For more information on the study or whether you are eligible, send an email to EDresearch@drexel.edu. 

• Responsible Party: Drexel University
• ClinicalTrials.gov Identifier: NCT03712462
• Other Study ID Numbers: 1803006178
• First Posted: October 19, 2018
• Last Update Posted: September 23, 2021
• Last Verified: September 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Drexel University:

Eating Disorder; Binge Eating; Binge Eating Disorder; Weight Loss

Additional relevant MeSH terms:

Disease; Body Weight; Weight Loss; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Pathologic Processes; Body Weight Changes; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive