NCT03175614已完成不适用
EVIDENT3 Study: A Randomized, Controlled Clinical Trial to Reduce Inactivity and Caloric Intake in Sedentary, Overweight People Using a Smartphone Application. Study Protocol.
Instituto de Investigación Biomédica de Salamanca2 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2017年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Weight reduction
研究概览
简要总结
This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the effects of the addition of an ICT tool developed for the Smartphone application and a Smartband in support of behavioral and educational recommendations to reduce weight.
详细描述
- Objetive: To develop and validate an application for the use in Smartphone in which the management of a SmartBand is included and evaluate the effect of adding this tool of information and communication technology (ICT), to a standardized intervention reduce weight, reduce sedestation time, increase physical activity and decrease total caloric intake in obese and sedentary subjects.
- Design and setting: A clinical of two parallel group, multicenter, randomized, aimed at assessing the effects of adding an ICT tool (intervention) to support behavioral and educational recommendations (control) in physical activity and weigh loss. Population: 700 obese and sedentary subjects will be included, 20 to 65 aged, selected by random sampling in 5 centers.
- Measurements and intervention: physical and sedeentary acivity will be assessed with an accelometer and IPAQ and Marshall Questionnaires, the nutrition by a food frequency and adherence to the Mediterranean diet survey and weight loss with body mass index and waist circumference. Vascular function with a wrist-worn tonometer (blood pressure, augmentation index and pulse rate) will be evaluated and also the Cardio Ankle Vascular Index and carotid intima media thickness. The advice on nutrition (plate method) and exercise will be common to both groups. The intervention group will be added a training for 3 months in use of ICT tool described, designed to foment a healthy and low-calorie diet and increased physical acivity and decreased sedentary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese subjects (IMC ≥ 27.5 to <40), classified as sedentary according to the short physical activity questionnaire validated in the EVIDENT II study.
排除标准
- •Older than 65 years are excluded, due to difficulties in the use of ICTs.
- •Advanced respiratory, renal or liver disease.
- •Several mental illness
- •Coronary or cerebrovascular atherosclerotic disease, grade II or higher NYHA heart failure.
- •Moderate or severe COPD
- •Muscular-skeletal pathology that inhibit mobility
- •Subjects who can not exercise or follow a hypocaloric diet.
- •Oncologic disease in treatment diagnosed in the last 5 years.
- •Terminal situation
- •Pregnancy
- •Bariatric surgery
- •Those with any other circumstance that the investigators consider could interfere with the study procedures
结局指标
主要结局
Weight reduction
时间窗: 1 year
Measurement by kilograms
次要结局
- Improve Quality of life(1 year)
- Increase steps/day(1 year)
- Decrease sedestation minute week(1 year)
- Adiponectin(1 year)
- Decrease total caloric intake/day(1 year)
- Augmentation index(1 year)
研究者
研究点 (2)
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