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Completed

NCT Number: NCT03712462

Improving Weight Loss Outcomes for Binge Eating Disorder.

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.

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Key information

Conditions

Eating Disorder Binge Eating Binge-Eating Disorder Body Weight Body Weight Changes Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University, Stratton Hall

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Behavior Therapy

Behavioral

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

Primary outcomes

  1. Weight Loss

    Time frame: 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 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).

Secondary outcomes

  1. Eating Disorder Examination Questionnaire

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

    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.

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Yale University

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2018
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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