Evaluation of the Efficacy of Two Lifestyle Interventions for Suboptimal Weight Loss After Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Weight loss change
研究概览
简要总结
Bariatric surgery is the only long-term established treatment for morbid obesity. However, some patients experience suboptimal weight loss after surgery and/or experience a significant weight regain. Unfortunately there are very few studies in this area and little is known about the causes for lack of success or the best approach to treat this group of patients. The main aim of this study is to compare the efficacy of two different lifestyle treatment programs in this group of patients: 1) Hospital-based outpatient program or 2) an inpatient treatment program consisting of 3 - 3-week stays at a rehabilitation center over a 1-year period. Secondary aim is to determine potential reasons for suboptimal weight loss after bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) >40kg/m2, or BMI>35kg/m2 with comorbidities
- •healthy volunteers with suboptimal weight loss
- •health with significant weight regain after Roux-n-Y Gastric Bypass, defined as failure to lose at least 40% Excess Weight Loss by 12 months postoperatively.
- •Significant weight regain: Regain of ≥15% of total weight lost after the first postoperative year.
排除标准
- •Pregnancy
- •enrollment in another obesity treatment
- •previous revisional bariatric surgery
- •planned bariatric surgery
- •past or ongoing drug or alcohol abuse
- •physical or mental impairment that interferes with the ability to comply to treatment
- •history of severe psychological disorder
- •history of severe eating disorder
- •current medication known to affect appetite or induce weight loss
研究组 & 干预措施
Outpatient group
Multidisciplinary outpatient programme including both individual and group-based therapy. During the first visit, every patient will have an individual consultation with the dietician, physiotherapist and psychiatric nurse. After this, the patients will be followed up in groups every month for the first four months and every two months afterwards up to one year. The intervention will focus on nutritional education, healthy eating, increased physical activity levels (aiming initially at 10 minutes/day, then increasing to 30 minutes/day) and cognitive therapy.
干预措施: Multidisciplinary outpatient programme (Behavioral)
Inpatient group
Inpatient lifestyle programme offered at a rehabilitation center consisting of a "continuous care" weight loss program, with three intermittent stays (each with three-week duration) over a one year period.
干预措施: Inpatient lifestyle programme (Behavioral)
结局指标
主要结局
Weight loss change
时间窗: from baseline to 1 year
Changes in body weight will be assessed at the end of the intervention (1 year)
次要结局
- Risk factors(One year)