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Improving Weight Loss Outcomes for Binge Eating Disorder.

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ClinicalTrials.gov Identifier: NCT03712462
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Drexel University

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 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 : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


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.




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.




Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


Contacts
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Contact: Research Coordinator 267-359-6289 EDresearch@drexel.edu

Locations
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United States, Pennsylvania
Drexel University, Stratton Hall Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Research Coordinator    267-359-6289    EDresearch@drexel.edu   
Sponsors and Collaborators
Drexel University
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT03712462     History of Changes
Other Study ID Numbers: 1803006178
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

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