Improving Weight Loss Outcomes for Binge Eating Disorder.

Sponsor

Drexel University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03712462

Collaborator

Yale University (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

126

Enrollment

Location

Arms

53.4

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

126 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.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 :

Aug 20, 2018

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Jan 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Weight Loss [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

Eating Disorder Examination Questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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