Psychosocial Issues and Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Change in Psychopathology as measured by the SCID
研究概览
简要总结
Bariatric surgery is associated with long-term weight loss, as well as short-term improvements in obesity-related medical comorbidities. However, a significant proportion of patients fail to lose sufficient weight, or experience significant weight regain. Although no robust predictors of response have been identified, pilot data that will be presented and reviewed suggest that surgery has profound effects on eating behaviors and psychosocial functioning, and that these factors may affect postoperative weight control.
The present investigation capitalizes on the Longitudinal Assessment of Bariatric Surgery (LABS) consortium to conduct an in-depth examination of the psychosocial aspects of surgery among a geographically, ethnically, and racially diverse sample of men and women undergoing bariatric surgery. This project unites experts in the areas of psychopathology, eating behaviors and quality of life to conduct a naturalistic study using state-of-the-art assessment tools; to document the relationships among psychosocial factors; and to examine psychosocial predictors of surgical outcomes.
详细描述
Primary Objective. Despite the obvious impact of bariatric surgery procedures on intake, no study to date has included a careful assessment of psychological factors, feeding patterns, energy intake and eating problems in this group of patients longitudinally. The Investigators believe that a careful examination of the structure of eating behavior and eating problems (e.g. vomiting) would be very helpful in guiding bariatric surgeons and dieticians who work with this group of patients in terms of dietary advice and recommendations, and with the prediction of eating problems and poor nutrient intake in the subgroup that develops such problems. This study involves prospective assessment of psychosocial outcomes of surgery by adding a supplemental battery to the LABS-2 assessment schedule. Conducting assessments at three of the LABS clinical sites assures the geographic, ethnic, and racial diversity of the sample, and hence enhances the potential to identify a subgroup or subgroups of patients susceptible to poor outcomes after surgery and the generalizability of study results.
This study would also include an evaluation of psychopathological and behavioral variables that might impact on weight loss and weight regain, and psychosocial complications post-operatively, as well as quality of life.
The overall goal of this study is to obtain detailed information that will allow a careful assessment of psychopathology, quality of life and eating behavior pre-surgically and at regular intervals for up to 7 years after the surgical intervention.
The Investigators believe that the instruments and procedures selected will allow a detailed examination of psychopathology, eating pathology and quality of life in detail.
The Investigators believe that the measures and tasks added at year 7 will allow the examination of theories of affect regulation, cognitive control, and reward processing in understanding postsurgical outcomes regarding pathological eating behavior and alcohol/substance use and their shared similarities as well as underlying neurobiological systems.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
- •Previous enrollment in LABS-1 and LABS-
- •BMI at baseline of greater than or equal to 35.
排除标准
- •Informed consent not obtained
- •Type 1 Diabetes Mellitus
- •Unlikely to comply with follow-up protocol (ie: geographically inaccessible for study visits)
- •Unable to communicate with local study staff
结局指标
主要结局
Change in Psychopathology as measured by the SCID
时间窗: annually up to 7 years post bariatric surgery
Structured Clinical Interview for DSM-IV, Patients Edition (SCID) will be administered to assess comorbid Axis I psychopathology.
次要结局
- Change in Quality of life as measured by the IWQOL(annually up to 7 years post bariatric surgery)
- Change in Depression as measured by the BDI(annually up to 7 years post bariatric surgery)
- Change in Quality of life as measured by the SF-36(annually up to 7 years post bariatric surgery)
- Change in Impulse Control as measured by the SCID-ICD module(annually up to 7 years post bariatric surgery)
- Change in Eating behaviors as measured by the EDE(annually up to 7 years post bariatric surgery)