Improving Weight Loss Outcomes for Binge Eating Disorder.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03712462|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|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.|
|Official Title:||Improving Weight Loss Outcomes for Binge Eating Disorder.|
|Actual Study Start Date :||August 20, 2018|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712462
|Contact: Research Coordinator||267-359-6289||EDresearch@drexel.edu|
|United States, Pennsylvania|
|Drexel University, Stratton Hall||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Research Coordinator 267-359-6289 EDresearch@drexel.edu|