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Completed

NCT Number: NCT04828655

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

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.

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Key information

Conditions

Hypertension Behavior Body Composition Body Weight Cardiovascular Diseases Diet, Mediterranean Disease Exercise Machine Learning Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Triglyceride-Storage; Disease Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alejandro Martínez Rodriguez

Alicante, 03690, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Cardiovascular variables; heart rate.

    Time frame: 9 months

    Heart rate measurement done with an activity wristband.

  2. Cardiovascular variables; blood pressure.

    Time frame: 9 months

    Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.

  3. Physical condition; time.

    Time frame: 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.

  4. Body Composition - Bioimpedance

    Time frame: 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.

  5. Weight

    Time frame: 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.

  6. Height

    Time frame: 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.

  7. Body Composition - Skinfolds

    Time frame: 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.

  8. Body Composition - Perimeters

    Time frame: 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.

  9. Body Composition - Diameters

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2021
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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