Improving Weight Loss Outcomes for Binge Eating Disorder.

NCT ID: NCT03712462

Last Updated: 2024-04-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2023-02-01

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.

Detailed Description

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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.

Conditions

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Eating Disorder Binge-Eating Disorder Weight Loss Binge Eating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The novel acceptance-based behavioral weight loss therapy is being compared to standard behavioral weight loss therapy for individuals with binge eating disorder.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ABBT Weight Loss Therapy for BED

Acceptance-Based Behavioral Weight Loss Therapy for BED

Group Type EXPERIMENTAL

Acceptance-Based Behavioral Weight Loss Therapy for BED

Intervention Type BEHAVIORAL

ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.

Standard Behavior Therapy

Standard Behavioral Weight Loss Therapy

Group Type ACTIVE_COMPARATOR

Standard Behavior Therapy

Intervention Type BEHAVIORAL

SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.

Interventions

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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.

Intervention Type BEHAVIORAL

Standard Behavior Therapy

SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Drexel University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Drexel University, Stratton Hall

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://drexel.edu/coas/academics/departments-centers/well-center/research/current-research-projects/

For more information on the study or whether you are eligible, send an email to [email protected].

Other Identifiers

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R01DK117072

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1803006178

Identifier Type: -

Identifier Source: org_study_id

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