Intensive Lifestyleintervention for the Treatment of Severe Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Acute and short term (12 months) effects of an intensive 10 to 14-weeks inpatient program with lifestyle modification for the treatment of morbidly obese patients on body composition and psychosocial health
研究概览
简要总结
The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (> 1 year) term effects on body composition and psychological health after a 10 to 14-weeks comprehensive lifestyle modification program for the treatment of severe obesity.
The aims of the PhD project are to investigate whether an intensive lifestyle intervention leads to acute and short term (< 1 year) changes in:
- The BMI/Weight
- Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and visceral fat area)
- Psychosocial factors such as eating behavior, anxiety and depression symptoms and health-related quality of life
详细描述
The study is based on data collected from patients at The Hjelp24 NIMI Ringerike Obesity Clinic, which is an inpatient program to address morbid obesity in adults. The study is a non-randomized clinical trial comparing the acute and long-term effects on physical and psychological health of the 10-14-weeks inpatient comprehensive lifestyle modification program for the treatment of morbidly obese patients.
In between the inpatient stay, the patients are followed up either by telephone, occasional mail and/or structured / weekly email.
In this project we prospectively follow two groups of patient included in the treatment programme in September 2010 and January 2011, respectively. In addition a control group with waiting-list patients is also included in the study, and they were recruited in October-November 2011
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •morbidly obese
排除标准
- •not able to walk slowly for 20 minutes
结局指标
主要结局
Acute and short term (12 months) effects of an intensive 10 to 14-weeks inpatient program with lifestyle modification for the treatment of morbidly obese patients on body composition and psychosocial health
时间窗: three years
次要结局
- Physical activity(Week 52)
- Binge eating(Week 52)
- Health related quality of life(Week 52)
- Binge Eating(Week 10-14)
- Body composition(Week 52)
- Depression(Week 52)
- Physical fitness(Week 52)
- Systolic Blood Pressure(Week 52)
- Lipids(Week 52)
- Explore the participants experiences with physical activity prior to, during and after the treatment programme(2-3 years post treatment)
- Anxiety(Week 10-14)
- Physical Activity(Week 10-14)
- Glucose(Week 52)
研究者
Professor Jorunn Sundgot-Borgen
Professor, PhD
Norwegian School of Sport Sciences