Clinical trial NCT03712462: Improving Weight Loss Outcomes for Binge Eating Disorder.
Official title: Improving Weight Loss Outcomes for Binge Eating Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Binge-Eating Disorder
Weight Loss
Binge Eating
Keywords: Eating Disorder
Binge Eating
Binge Eating Disorder
Weight Loss
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Yale University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-10-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Detailed description: In the current study, we propose to (a) compare the efficacy of an acceptance-based behavioral treatment (ABBT) that targets both binge eating and weight loss in patients with binge eating disorder (BED) to a Standard Behavioral Weight Loss Treatment (SBT), (b) evaluate the extent to which ABBT and SBT target shared maintenance factors for binge eating and overeating episodes, and (c) assess whether treatment efficacy is moderated by baseline values of constructs targeted in ABBT. Our study will be the first to evaluate an ABBT for BED designed to 1) address maintenance factors that give rise to both binge eating episodes and overeating episodes without loss of control and 2) increase adherence to BWL prescriptions.

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

Primary outcomes:
measure: Weight Loss
timeFrame: 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 outcomes:
measure: Eating Disorder Examination Questionnaire
timeFrame: Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University, Stratton Hall
state: Pennsylvania
Study officials:
References: