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

Primary Purpose

Hypertension, Diet, Mediterranean, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.
Sponsored by
University of Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alejandro Martínez Rodriguez

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

CONTROL GROUP

EXPERIMENTAL GROUP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cardiovascular variables; heart rate.
Heart rate measurement done with an activity wristband.
Cardiovascular variables; blood pressure.
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2021
Last Updated
September 7, 2021
Sponsor
University of Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT04828655
Brief Title
Analysis of Bioparametric Measures for Correlating Daily Habits and Reducing Blood Pressure
Official Title
Análisis de Medidas bioparamétricas Para Correlacionar Los hábitos Diarios y Reducir la tensión Arterial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alicante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diet, Mediterranean, Cardiovascular Diseases, Exercise, Machine Learning, Overweight and Obesity, Body Composition, Triglyceride-Storage; Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONTROL GROUP
Arm Type
No Intervention
Arm Description
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.
Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.
Intervention Description
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 Outcome Measure Information:
Title
Cardiovascular variables; heart rate.
Description
Heart rate measurement done with an activity wristband.
Time Frame
9 months
Title
Cardiovascular variables; blood pressure.
Description
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Time Frame
9 months
Title
Physical condition; time.
Description
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.
Time Frame
9 months
Title
Body Composition - Bioimpedance
Description
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.
Time Frame
9 months
Title
Weight
Description
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.
Time Frame
9 months
Title
Height
Description
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.
Time Frame
9 months
Title
Body Composition - Skinfolds
Description
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.
Time Frame
9 months
Title
Body Composition - Perimeters
Description
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.
Time Frame
9 months
Title
Body Composition - Diameters
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Martínez Rodríguez
Organizational Affiliation
Alicante University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alejandro Martínez Rodriguez
City
Alicante
ZIP/Postal Code
03690
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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