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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Triglyceride-Storage; Disease; Hypertension; Machine Learning; Overweight and Obesity; Diet, Mediterranean; Exercise; Body Composition
• Interventions: Behavioral: Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.

• Registration Number: NCT04828655
• Lead Sponsor: University of Alicante

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.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-01-07
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-02
• Study Completion: 2021-05-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EXPERIMENTAL GROUP	Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Alejandro Martínez Rodriguez; 🇪🇸 Alicante, Spain