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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04828655
Enrollment
36
Registered
2021-04-02
Start date
2020-09-01
Completion date
2021-05-31
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Detailed 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.

Interventions

BEHAVIORALUse 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.

Sponsors

University of Alicante
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular variables; heart rate.9 monthsHeart rate measurement done with an activity wristband.
Cardiovascular variables; blood pressure.9 monthsMeasurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Physical condition; time.9 monthsThe 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.
Body Composition - Bioimpedance9 monthsAssessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass, fat-free mass and visceral mass.
Weight9 monthsThe 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.
Height9 monthsThe 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.
Body Composition - Skinfolds9 monthsThe 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.
Body Composition - Perimeters9 monthsThe 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.
Body Composition - Diameters9 monthsThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026