E-support for Healthcare Processes - WEIGHT LOSS
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
The purpose of the study is to establish and clinically evaluate a new approach to treating obesity by using information and communication technologies (ICT). A mobile environment and organizational interventions to improve the process of an integrated treatment of people with obesity will be identified, developed, introduced and clinically evaluated.
详细描述
A mobile environment to improve the process of an integrated treatment of obese people will be identified, developed, introduced and clinically evaluated. The study will include 150 patients aged between 25 to 65 for men and 25 to 70 for women, diagnosed with obesity (BMI≥30 or BMI>27,5 and 20% risk or more for developing a cardiovascular diseases). One group of patients will visit conventional live workshops for weight loss and the other group will use ICT. At the initial examination by the doctor all survey participants will have measured blood pressure, body mass, waist circumference, percentage of body fat, percentage of skeletal muscle, resting metabolic rate, estimated risk of developing cardiovascular disease and will be directed to laboratory examination (blood lipids and cholesterol, blood sugar). Both groups will go through 16 workshops for weight loss. Each week they will monitor their body mass, waist circumference, physical activity (type, duration, intensity) and food intake (type, quantity). After six months all survey participants will be examined again. We will compare effectiveness of ICT weight loss group with conventional weight loss group.
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI≥30 or BMI>27,5 and 20% or more risk for developing a cardiovascular diseases
- •Age between 25 - 65 years for men and 25 - 70 years for women
- •Own a mobile phone
- •Know how to use a computer
- •Know how to use an e-mail
- •Signed voluntary consent to participate in the survey
排除标准
- •People with movement disorders
- •Age<18 years or age>70 years for women and 65 years for men
- •Pregnancy, breast feeding, intention of getting pregnant during the study, period after childbirth (9 months)
- •Does not own or know how to handle a mobile phone
- •No internet access
- •Known hospitalization for severe psychiatric disorders (schizophrenia, psychosis)
- •Known history of eating disorders (anorexia, bulimia nervosa and others)
- •Cancer incidence in the last 5 years
- •Heart problems, chest pain, nausea, dizziness
- •Chronic inflammatory diseases
- •Other unregulated chronic diseases
结局指标
主要结局
Weight loss
时间窗: 16 weeks
Weight loss of 5 to 10 % of the body mass at the beginning of the study
次要结局
- Successful maintenance or improvement of the following measured parameter: Body mass index.(16 weeks)
- Successful maintenance or improvement of the following measured parameter: waist circumference(16 weeks)