Preoperative Lifestyle Intervention in Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- surgical complications and outpatient visits
研究概览
简要总结
The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.
详细描述
This is a randomized, controlled trial to evaluate the impact of a preoperative lifestyle intervention that targets diet, exercise, and preparation for surgery as an adjunct to the surgical treatment of obesity. Patients will be randomized to a 6-month lifestyle intervention (n = 100) or to usual care (n = 100) prior to undergoing bariatric surgery. We aim to evaluate the effect of the intervention on select pre- and postoperative outcomes. We hypothesize that patients who participate in the preoperative intervention will exhibit greater improvements in weight and related outcomes and better preparation for surgery than those who receive usual care. After operation, we hypothesize that patients who participate in the intervention will exhibit better compliance and fewer behavior-related eating problems, as well as a lower rate of complications and fewer outpatient visits with surgery-related conditions than those who received usual preoperative care. Our secondary aim is to determine whether the intervention affects weight/BMI trajectory through 24 months after operation.
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
- None
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
- •Any candidate for weight loss surgery who is at least 18 years old [At the University of Pittsburgh Medical Center, bariatric surgery is recommended as a treatment for individuals with Class III obesity (BMI > 40), or Class II obesity (BMI 35- 40) and serious obesity-related health problems]
排除标准
- •Mental retardation or psychosis
- •Previously diagnosed genetic obesity syndrome
- •Participation in a structured weight management program in the 6 months prior to study enrollment
- •Uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment
- •Pregnant or lactating in the previous 6 months
- •Taking a medication known to affect body weight such as oral steroids in the previous 6 months
- •Any previous surgery for weight loss
- •Deemed high risk surgical candidate.
结局指标
主要结局
surgical complications and outpatient visits
时间窗: 6- and 12-months post surgery
weight and related outcomes (BMI, cardiovascular risk, quality of life)
时间窗: pre and post intervention
preparation for surgery (eating, activity and knowledge of surgery)
时间窗: pre and post intervention
compliance and eating problems (vomiting, dumping, plugging etc.)
时间窗: 6- and 12-months post surgery
次要结局
- Weight/BMI trajectory(pre- and post-intervention; 6-, 12 and 24 months postop)
研究者
Melissa Kalarchian
Associate Professor
Duquesne University