SHAPE AND MOTION - Medical Accompanied Slimming
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Weight loss in kg
研究概览
简要总结
Background: Overweight and obesity affect health, quality of life and ability to work. Therefore, the scientifically evaluated program "SHAPE AND MOTION - medically ◦ accompanied ◦ slimming" was developed to support overweight and obese people in weight loss.
Method: In a randomized controlled clinical trial, the effect of a lifestyle intervention with meal replacement by formula diet, exercise stimulation, and telemedicine coaching is examined compared to a control group with routine care. The learning contents are taught in 7 group trainings, a practical unit with shopping and cooking training, as well as in 4 individual telephone conversations. The state of health is examined at the beginning, after 12 and 26 weeks.
Objective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index ≥ 25 kg/m2
排除标准
- •acute diseases such as respiratory or gastrointestinal infections
- •severe diseases such as tumors, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic bowel disease, psychosis, liver cirrhosis, (macro) nephropathy, renal insufficiency with glomerular filtration rate (GFR) <30
- •ongoing chemotherapy, chron. Cortisone treatment
结局指标
主要结局
Weight loss in kg
时间窗: 26 weeks
Estimated treatment difference
次要结局
- lean body mass in kg(26 weeks)
- energy expenditure in kcal(26 weeks)
- fasting blood glucose in mg/dl(26 weeks)
- body mass index in kg/m2(26 weeks)
- waist circumference in cm(26 weeks)
- muscle mass in kg(26 weeks)
- blood pressure in mmHg(26 weeks)
- quality of life (sf-12 questionnaire) in units on a scale(26 weeks)
- total cholesterol in mg/dl(26 weeks)
- HbA1c in %(26 weeks)
- physical activity in min/day(26 weeks)
- triglycerides in mg/dl(26 weeks)
- fat mass in kg(26 weeks)
- hip circumference in cm(26 weeks)
- depression (German version of the Center for Epidemiological Studies-Depression [CES-D] Scale) in units on a scale(26 weeks)
- physical activity in steps/day(26 weeks)
- LDL cholesterol in mg/dl(26 weeks)
- insulin in µU/ml(26 weeks)
- eating behaviour (German version of the Three-factor Eating Questionnaire [TFEQ]) in units on a scale(26 weeks)
- HDL cholesterol in mg/dl(26 weeks)
- uric acid in mg/dl(26 weeks)
- creatinin in mg/dl(26 weeks)
- medication in mg/day(26 weeks)