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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03690
    • Alejandro Martínez Rodríguez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular variables; heart rate.	Heart rate measurement done with an activity wristband.	9 months
Cardiovascular variables; blood pressure.	Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.	9 months
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Alicante
• Investigators: Principal Investigator: Alejandro Martínez Rodríguez, Alicante University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): January 7, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Cardiovascular Diseases; Overweight
• Other Study ID Numbers: UA-2020-04-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No