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Analysis of Bioparametric Measures for Correlating Daily Habits and Reducing Blood Pressure

2021年9月7日 更新者:Prof. Dr. Alejandro Martínez-Rodríguez、University of Alicante

Análisis de Medidas bioparamétricas Para Correlacionar Los hábitos Diarios y Reducir la tensión Arterial

To study the effects of the use of a mobile application plus recommendations based on a Mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in a Spanish adult population.

研究概览

详细说明

In the Valencian Community, 93% of deaths appear to be related to (non-communicable) diseases such as: obesity, hypertension and diabetes. In 2013, cardiovascular diseases were the leading cause of death in women (34.4%) and the second in men (28.0%). There is a forecast that overweight and obesity will reach levels of 89% and 85% in men and women, respectively, by 2030. This will result in an increase in the obesity-related prevalence of coronary heart disease by 97%. The promotion of research on arterial hypertension and how it could be reduced is one of the basic pillars in decreasing the prevalence and incidence in the Spanish population. Research should anticipate and develop treatments and vaccines that prevent new scenarios of widespread infection.

Therefore, the main objective is to study the effects of the use of a mobile application plus recommendations based on a Mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in the adult Spanish population.

研究类型

介入性

注册 (实际的)

36

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Alicante、西班牙、03690
        • Alejandro Martínez Rodríguez

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Over 40 years old
  • Healthy.
  • Blood pressure levels slightly elevated but less than 140 mm Hg and/or diastolic pressure less than 90 mm Hg.
  • Smartphone access

Exclusion Criteria:

  • Subjects with diseases.
  • Consumption of drugs and/or supplements.
  • Subjects with food intolerances/allergies.
  • Subjects with muscle or joint injury.
  • Subjects with impossibility to follow up the intervention.
  • Refusal of informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:CONTROL GROUP
Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity. Specific micronutrient intake focused on improving cardiovascular parameters and body composition.
实验性的:EXPERIMENTAL GROUP
Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity through an application based on machine learning. Intake of specific micronutrients focused on improving cardiovascular parameters and body composition.
Specific diet program and moderate physical activity, all guided and mediated by a mobile application. As well as the recording and monitoring of periodic evaluations of health indicators.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cardiovascular variables; heart rate.
大体时间:9 months
Heart rate measurement done with an activity wristband.
9 months
Cardiovascular variables; blood pressure.
大体时间:9 months
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
9 months
Physical condition; time.
大体时间:9 months
The evaluation of the physical condition will be carried out by means of the mile test, in which the subjects have to cover this distance walking, and in the shortest possible time.
9 months
Body Composition - Bioimpedance
大体时间:9 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass, fat-free mass and visceral mass.
9 months
Weight
大体时间:9 months
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan). From the body mass and height data, the BMI (kg/m2) will be obtained.
9 months
Height
大体时间:9 months
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany). From the body mass and height data, the BMI (kg/m2) will be obtained.
9 months
Body Composition - Skinfolds
大体时间:9 months
The kinanthropometric assessment will be carried out using the methodology proposed for the restricted profile by the International Society for the Development of Kineanthropometry (ISAK). The material used to measure skinfolds will be a plicometer.
9 months
Body Composition - Perimeters
大体时间:9 months
The kinanthropometric assessment will be carried out using the methodology proposed for the restricted profile by the International Society for the Development of Kineanthropometry (ISAK). The material used to measure perimeters will be a tape.
9 months
Body Composition - Diameters
大体时间:9 months
The kinanthropometric assessment will be carried out using the methodology proposed for the restricted profile by the International Society for the Development of Kineanthropometry (ISAK). The material used to measure diameters will be a pachymeter.
9 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Alejandro Martínez Rodríguez、Alicante University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年9月1日

初级完成 (实际的)

2021年1月7日

研究完成 (实际的)

2021年5月31日

研究注册日期

首次提交

2021年3月23日

首先提交符合 QC 标准的

2021年3月30日

首次发布 (实际的)

2021年4月2日

研究记录更新

最后更新发布 (实际的)

2021年9月8日

上次提交的符合 QC 标准的更新

2021年9月7日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • UA-2020-04-16

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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