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临床试验/NCT03712462
NCT03712462已完成不适用

Improving Weight Loss Outcomes for Binge Eating Disorder.

Drexel University2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2018年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
2
主要终点
Weight Loss

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Weight Loss

时间窗: 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).

次要结局

  • Eating Disorder Examination Questionnaire(Baseline, Post-Treatment (1 year after baseline), and 1 Year Follow-Up (2 years after baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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