- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03712462
Improving Weight Loss Outcomes for Binge Eating Disorder.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Drexel University, Stratton Hall
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1803006178
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Binge-Eating Disorder
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University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersCompletedEating Disorder | Binge-eating DisorderUnited States
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ShireCompleted
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Lindner Center of HOPEUniversity of CincinnatiCompleted
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Sao Jose do Rio Preto Medical SchoolFundação de Amparo à Pesquisa do Estado de São PauloCompletedBinge-Eating Disorder | Eating Disorders | Eating Behavior | Eating Disorder | Binge Eating Disorder Associated With ObesityBrazil
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Nova Scotia Health AuthorityCompletedBinge-Eating Disorder | Eating DisorderCanada
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Alexandria UniversityActive, not recruitingBinge Eating DisorderEgypt
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Heidelberg UniversitySelfapy GmbHCompleted
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Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedBinge-Eating DisorderUnited States
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Nova Scotia Health AuthorityCompletedBinge Eating DisorderCanada
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