跳至主要内容
临床试验/NCT02016014
NCT02016014已完成不适用

Effectiveness of the Use of a Mobile Tool Added to a Standard Intervention in Improving Lifestyles in Adults

Instituto de Investigación Biomédica de Salamanca2 个研究点 分布在 1 个国家目标入组 833 人开始时间: 2014年1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
833
试验地点
2
主要终点
Mediterranean diet compliance

研究概览

简要总结

Objectives: To develop and validate a mobile tool for use in Smartphone supports as a first step, and to evaluate the effect of adding this new tool of information and communication technologies (ICT), to a standardized intervention to increase adherence to nutritional recommendations of the Mediterranean diet and increase physical activity as primary endpoint. Analyze adherence and intervention results from a gender perspective. Methodology: Multicenter, randomized double-blind, clinical trial with two parallel group, aimed at assessing the effects of adding an TIC tool, developed for the Smartphone application (intervention), in support of behavioral and educational recommendations (control) in the increased physical activity and adaptation to the Mediterranean dietary pattern. Population: 1215 included subjects younger than 70 years from the project EVIDENT who agree to participate. Measurement and interventions: Physical activity will be assessed with the accelerometer and the 7-PAR day and adaptation to the Mediterranean diet with a questionnaire of adherence and a food frequency survey. It will also assess vascular structure and function, central blood pressure, Augmentation index, pulse rate and of carotid intima-media thickness. The counsel to adaptation the Mediterranean diet (based on the project PREDIMED) and exercise (based on PEPAF project), will be common to both groups. The intervention group will be added training and use of an application on a Smartphone designed to promote healthy eating and increased physical activity.

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 (Investigator)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects since 20 to 70 years

排除标准

  • Older than 70 years are excluded, due to difficulties in the use of ICTs and those who can not exercise or follow a diet Mediterranean diet

结局指标

主要结局

Mediterranean diet compliance

时间窗: 1 year

Measurement by medierranean diet questionary from PREDIMED study

次要结局

  • Increase physical activity(1 year)

研究者

发起方
Instituto de Investigación Biomédica de Salamanca
申办方类型
Other
责任方
Sponsor

研究点 (2)

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