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

NCT04828655 | Completed DMC

• 1 other identifier: UA-2020-04-16
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

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 GROUP

EXPERIMENTAL

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.

Interventions

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.

EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

Alejandro Martínez Rodriguez

Alicante, 03690, Spain

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Motor Activity; Overweight; Obesity; Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Alejandro Martínez Rodríguez

  Alicante University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 2, 2021
• Study Start: September 1, 2020
• Primary Completion: January 7, 2021
• Study Completion: May 31, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)