Intensificación y monitorización telemática Personalizada de la modificación Del Estilo de Vida en el Tratamiento de la Obesidad y la prevención Del Riesgo cardiometabólico
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
This project is based on the contribution that could offer a technological system for a continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic complications in high risk population.
The main objective of PREDIRCAM study is to evaluate the benefits obtained with the use in high cardiometabolic risk individuals of a telemedical platform integrating applications for monitoring and providing recommendations to improve lifestyle habits (diet and physical activity) in a healthier way.
The study population are obese subjects (type I or II) aged between 25 and 65 years with a 12 month follow-up. In this population it will be analysed the cost-effectiveness of a telemedic assistance with a technological system and its ability to modify lifestyle habits, reduce weight and cardiovascular risk associated parameters.
Previously to the clinical implementation, a pilot study for testing the telemedical system will be made. Efficacy and security variables will be evaluated along the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 是
入选标准
- •Preclinical Phase:
- •People over 18 years with or without obesity and with ability for technology management
- •Clinical Phase:
- •People between 18 and 65 years.
- •Obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m2:
- •Grade I or II without sleep apnea syndrome and ischemic heart disease
- •Absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study.
- •People with ability for technology management
排除标准
- •Preclinical Phase:
- •Serious illness and / or disabling
- •Clinical Phase:
- •Diabetes defining according to American Diabetes Association (ADA) criteria.
- •Subjects with moderate to severe active disease at the time of inclusion in the study protocol
- •Impaired glucose metabolism related diseases associated with diabetes mellitus or drugs interfering carbohydrate metabolism.
- •Cardiovascular disease
- •Dyslipidemia or hypertension requiring drug treatment.
- •Alcohol consumption
- •Serious illness and / or disabling
研究组 & 干预措施
Conventional assistance
Usual treatment of obesity in terms of monitoring lifestyle habits
干预措施: Standard care (Other)
Telemedic assistance
telemedical assistance with a technological system to provide a continuous monitoring of lifestyle habits and individualized treatment of obesity
干预措施: Telemedic assistance with a technological system (Device)
结局指标
主要结局
Weight loss
时间窗: 1 year
次要结局
- Cardiometabolic risk prevention(1 year)