Improving Weight Loss Outcomes for Binge Eating Disorder.

Study Overview
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Brief Summary
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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.

Official Title
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Improving Weight Loss Outcomes for Binge Eating Disorder.

Conditions
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Eating Disorder, Binge-Eating Disorder, Weight Loss, Binge Eating

Intervention / Treatment
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* Behavioral: Acceptance-Based Behavioral Weight Loss Therapy for BED
* Behavioral: Standard Behavior Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABBT Weight Loss Therapy for BED<br>Acceptance-Based Behavioral Weight Loss Therapy for BED | Behavioral: Acceptance-Based Behavioral Weight Loss Therapy for BED<br>* ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.<br>|
| Active Comparator: Standard Behavior Therapy<br>Standard Behavioral Weight Loss Therapy | Behavioral: Standard Behavior Therapy<br>* SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating Disorder, Binge Eating, Binge Eating Disorder, Weight Loss