Improving Weight Loss Outcomes for Binge Eating Disorder.

NCT03712462 | Completed Results DMC

• 2 other identifiers: 1803006178R01DK117072
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorder; Binge-Eating Disorder; Weight Loss; Binge Eating

Keywords

Eating Disorder; Binge Eating; Binge Eating Disorder; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  Between-group changes in percent weight loss from baseline 1 month, 3 months, and 6 months into the study, at post-treatment (1 year after baseline) and at the one year follow-up assessment (2 years after the baseline).

  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 (1)

• Eating Disorder Examination Questionnaire

  Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline)

Study Arms (2)

ABBT Weight Loss Therapy for BED

EXPERIMENTAL

Acceptance-Based Behavioral Weight Loss Therapy for BED

Behavioral: Acceptance-Based Behavioral Weight Loss Therapy for BED

Standard Behavior Therapy

ACTIVE COMPARATOR

Standard Behavioral Weight Loss Therapy

Behavioral: Standard Behavior Therapy

Interventions

Acceptance-Based Behavioral Weight Loss Therapy for BED BEHAVIORAL

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

ABBT Weight Loss Therapy for BED

Standard Behavior Therapy BEHAVIORAL

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

Standard Behavior Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the DSM-5 criteria for Binge Eating Disorder
• Have a BMI range of 27-50kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead
• Yale University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Drexel University, Stratton Hall

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• For more information on the study or whether you are eligible, send an email to EDresearch@drexel.edu.

MeSH Terms

Conditions

Feeding and Eating Disorders; Binge-Eating Disorder; Weight Loss; Bulimia

Interventions

Beds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Body Weight Changes; Body Weight; Hyperphagia

Intervention Hierarchy (Ancestors)

Equipment and Supplies, Hospital; Equipment and Supplies

Results Point of Contact

• Title: Dr. Adrienne Juarascio
• Organization: Drexel University

adrienne.s.juarascio@drexel.edu

215-553-7154

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The novel acceptance-based behavioral weight loss therapy is being compared to standard behavioral weight loss therapy for individuals with binge eating disorder.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: August 20, 2018
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2024-04

Locations

US (1)