How to Optimize Weight Loss Maintenance After a Very-low Calorie Diet?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- body weight
研究概览
简要总结
Very-low calorie diets are relatively safe and effective in inducing significant weight loss, when used in selective individuals and under clinical supervision. However, weight loss maintenance in the long-term remains the main challenge, with many experiencing a significant weight regain. Several compensatory mechanisms are activated under weight reduction, both at the level of energy intake (such as increased appetite) and energy expenditure (such as reduced energy expenditure), and increase the risk of relapse.
The main aim of this study is to compare the effect of two multidisciplinary lifestyle interventions on weight loss maintenance at one year, after initial weight loss during 8 weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an outpatient program in the obesity unit of the local hospital, or to an inpatient program consisting of a "continuous care" intervention, with three intermittent stays (each with three-week duration) in a rehabilitation center over a one year period. Moreover, the investigators aim to assess the impact of weight loss (achieved with a very low calorie diet) and weight loss maintenance on compensatory mechanisms activated during weight reduction.
详细描述
This study included a sub-study (n=30) to determine the timeline over which compensatory mechanisms (at both the level of energy expenditure and appetite control system) are activated with progressive weight loss. Additional measurements were taken at day-3, 5 and 10 % weight loss, and after 4 weeks weight stabilization (after gradually reintroduction of food).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •volunteers from Central Norway
- •if female: taking oral contraceptives or post-menopausal
- •body mass index 30-45 kg/m2
- •stable weight (<2kg variation in the last 3 months)
- •not currently dieting to lose weight
排除标准
- •Pregnancy
- •breast feeding
- •drug or alcohol abuse within the last two years
- •current medication known to affect appetite or induce weight loss
- •enrollment in another obesity treatment program
- •history of psychological disorders
- •history of eating disorders
- •history of diabetes type 1 or 2
- •gastrointestinal disorders (particular cholelithiasis)
- •kidney -, liver -, lung- or cardiovascular disease
- •malignancies
结局指标
主要结局
body weight
时间窗: 1 year (changes from baseline to one year)
body weight change after end of very-low calory diet
次要结局
- resting metabolic rate, short-term(10 weeks)
- appetite, long-term(1 year)
- appetite, short-term(10 weeks)
- exercise efficiency, long-term(1 year)
- physical activity level, long-term(1 year)
- exercise efficiency, short-term(10 weeks)
- physical activity level, short-term(10 weeks)
- resting metabolic rate, long-term(1 year)
- Sleep duration and quality(Baseline, end of weigth loss phase and 1 year)