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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828655
• Other study ID #: UA-2020-04-16
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: University of Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 31, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Composition
• Cardiovascular Diseases
• Diet, Mediterranean
• Exercise
• Hypertension
• Machine Learning
• Overweight
• Overweight and Obesity
• Triglyceride-Storage; Disease

Intervention

Behavioral:
• Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.
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.

Locations

Country	Name	City	State
Spain	Alejandro Martínez Rodriguez	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular variables; heart rate.	Heart rate measurement done with an activity wristband.	9 months
Primary	Cardiovascular variables; blood pressure.	Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.	9 months
Primary	Physical condition; time.	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
Primary	Body Composition - Bioimpedance	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
Primary	Weight	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
Primary	Height	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
Primary	Body Composition - Skinfolds	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
Primary	Body Composition - Perimeters	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
Primary	Body Composition - Diameters	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