The Effect of Lifestyle Treatment on Physical Capacity, Maximal Strength, Eating Behavior and Quality of Life in Patients With Morbid Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Weight change at 2-year follow up
研究概览
简要总结
The effect of lifestyle treatment on physical capacity, maximal strength, eating behavior and quality of life in patients with morbid obesity (LIFETIME)
详细描述
In this study, the investigators will investigate whether more intensive day-based lifestyle treatment process have a better effect on weight loss and health-related quality of life than a previous treatment. Investigators also want to investigate whether patients with good physical capacity (maximal oxygen uptake) and bone strength (maximum bone strength) before initiating treatment and / or after 3 and 6 months intensive training may have greater weight loss 1 and 2 years after treatment than patients with lower physical capacity and bone strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Treatment seeking morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the Vestfold Hospital Trust.
排除标准
- •Uncompensated heart failure
- •Recent myocardial infarction or stroke (<½ years)
- •Severe arrhythmia or heart failure
- •Unstable angina pectoris
- •Renal failure
- •Pregnancy
- •Severe eating disorders
- •Active substance abuse
结局指标
主要结局
Weight change at 2-year follow up
时间窗: Changes from baseline body weight at 2-year follow up.
Effect of intensive treatment on weight loss changes at 2- year follow up. Body weight was measured with patients wearing light clothing and no shoes on Scanvaegt DS-530 (Århus, Denmark) at baseline and at 2-year follow up.
次要结局
- Physical capacity change at 2-year follow up(Changes from baseline physical capacity at 2-year follow up.)
- Health-related quality of life (HRQoL) - Weight-Related Symptom Measure (WRSM), change at 2-year follow up(Changes from baseline WRSM at 2-year follow up.)
- Weight change at 1-year follow up(Changes from baseline body weight at 1-year follow up.)
- Health-related quality of life (HRQoL) - Short Form Health Survey (RAND-36), change at 2-year follow up(Changes from baseline RAND-36 at 2-year follow up.)
- Maximal leg strength change at 2-year follow up(Changes from baseline maximal leg strenght at 2-year follow up.)
- Three Factor Eating Questionnaire (TFEQ - R21)(Changes from baseline TFEQ-R21 at 2-year follow up.)
- Health-related quality of life (HRQoL) - Impact on Weight Questionnaire (IWQOL-Lite), change at 2-year follow up(Changes from baseline IWQOL-Lite at 2-year follow up.)
- The Power of Food scale (PFS) change at 2-year follow up(Changes from baseline PES at 2-year follow up.)
- Binge Eating Scale (BES), change at 2-year follow up(Changes from baseline BES at 2-year follow up.)
研究者
Jarle Berge
Principal investigator
Sykehuset i Vestfold HF