Improving Weight Loss Outcomes for Binge Eating Disorder.

Weight Loss Clinical Trial

Official title:

Improving Weight Loss Outcomes for Binge Eating Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712462
• Other study ID #: 1803006178
• Secondary ID: R01DK117072
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: February 1, 2023

Study information

• Verified date: April 2024
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Body Weight
• Bulimia
• Eating Disorder
• Feeding and Eating Disorders
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Drexel University, Stratton Hall	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Drexel University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline)

External Links

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