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

NCT ID: NCT04828655

Last Updated: 2021-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alicante

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Alejandro Martínez-Rodríguez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alejandro Martínez Rodríguez

Role: PRINCIPAL_INVESTIGATOR

Alicante University

Locations

Alejandro Martínez Rodriguez

Alicante, , Spain

Countries

Spain

Other Identifiers

UA-2020-04-16

Identifier Type: -

Identifier Source: org_study_id