Analysis of Bioparametric Measures for Correlating Daily Habits and Reducing Blood Pressure
7. september 2021 opdateret af: Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
Análisis de Medidas bioparamétricas Para Correlacionar Los hábitos Diarios y Reducir la tensión Arterial
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
36
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alicante, Spanien, 03690
- Alejandro Martínez Rodríguez
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: 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.
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Eksperimentel: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cardiovascular variables; heart rate.
Tidsramme: 9 months
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Heart rate measurement done with an activity wristband.
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9 months
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Cardiovascular variables; blood pressure.
Tidsramme: 9 months
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Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
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9 months
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Physical condition; time.
Tidsramme: 9 months
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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.
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9 months
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Body Composition - Bioimpedance
Tidsramme: 9 months
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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.
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9 months
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Weight
Tidsramme: 9 months
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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.
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9 months
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Height
Tidsramme: 9 months
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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.
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9 months
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Body Composition - Skinfolds
Tidsramme: 9 months
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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.
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9 months
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Body Composition - Perimeters
Tidsramme: 9 months
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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.
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9 months
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Body Composition - Diameters
Tidsramme: 9 months
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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.
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9 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Alejandro Martínez Rodríguez, Alicante University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2020
Primær færdiggørelse (Faktiske)
7. januar 2021
Studieafslutning (Faktiske)
31. maj 2021
Datoer for studieregistrering
Først indsendt
23. marts 2021
Først indsendt, der opfyldte QC-kriterier
30. marts 2021
Først opslået (Faktiske)
2. april 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UA-2020-04-16
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Hjerte-kar-sygdomme
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