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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04828655
Other study ID # UA-2020-04-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date May 31, 2021

Study information

Verified date September 2021
Source University of Alicante
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date May 31, 2021
Est. primary completion date January 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Spain Alejandro Martínez Rodriguez Alicante

Sponsors (1)

Lead Sponsor Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

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