- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05093803
Improvement of Physical and Physiological Parameters Through the Use of a Mobile App
Study of Physical and Physiological Changes Through the Use of a Mobile App That Promotes Healthy Habits
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Scientific evidence has shown that the adoption of the Mediterranean diet is a protective factor against the appearance of several types of cancer, cardiovascular diseases, aging and obesity due to the amount of nutrients with anti-cancer, anti-inflammatory and anti-obesity properties that jointly contribute to the maintenance of health status. The antitumor effects of the Mediterranean diet are mainly due to the combination of antioxidant elements, fiber and polyunsaturated fats. Therefore, this dietary pattern is essential as a preventive measure against the onset of cancer and other chronic diseases, but also to reduce health care costs.
Monitoring physical activity should be considered as a central factor when addressing precision nutrition. Perform physical activity and exercise, as they are key components of energy expenditure and balance, in addition, structural changes occur in muscles, increase in the number of mitochondria in fiber, secretion of metabolically beneficial hormones with reversal of muscle insulin resistance and reduction of hepatic lipogenesis. Regardless of intensity, short-term exercise has been shown to improve adiposity and insulin sensitivity, which may help reduce metabolic risk. Boutcher et al. also demonstrated that intermittent aerobic and anaerobic exercise performed at an intensity >70% of maximal oxygen uptake significantly reduces ambulatory and office blood pressure in hypertensive individuals.
The development of this app aims, through self-management and visualizing the altered parameters and how they will evolve in your body in the short, medium and long term, to increase the population's commitment to these pathologies, in order to improve their health.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Alicante
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Elche, Alicante, Spanien, 03202
- Nutrición Selecta
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Men and women over 21 years of age
Exclusion Criteria:
- Volunteers who do not have access to a smartphone.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: CONTROL GROUP
Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity.
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Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.
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Eksperimentel: APP GROUP
Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity through the use of an app based on machine learning, so they have constant stimuli for the improvement of the parameters.
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Use of a mobile application based on machine learning with the aim of improving health parameters and body composition. 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
Tidsramme: 24 months
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The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
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24 months
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HEIGHT
Tidsramme: 24 months
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The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
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24 months
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WAIST CIRCUMFERENCE
Tidsramme: 24 months
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The kinanthropometric evaluation is based on the methodology proposed for the restricted profile by the International Society for the Development of Kinanthropometry (ISAK).
The material used to measure the perimeters will be a tape.
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24 months
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HIP CIRCUMFERENCE
Tidsramme: 24 months
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The kinanthropometric evaluation is based on the methodology proposed for the restricted profile by the International Society for the Development of Kinanthropometry (ISAK).
The material used to measure the perimeters will be a tape.
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24 months
|
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CHOLESTEROL
Tidsramme: 24 months
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The blood cholesterol level is obtained through a blood test.
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24 months
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TRIGLICERIDES
Tidsramme: 24 months
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The blood triglicerides level is obtained through a blood test.
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24 months
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BLOOD PREASURE
Tidsramme: 24 months
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Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
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24 months
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FAT MASS
Tidsramme: 24 months
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Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
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24 months
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LEAN BODY MASS
Tidsramme: 24 months
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Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of lean body mass.
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24 months
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VISCERAL FAT
Tidsramme: 24 months
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Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
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24 months
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HEART RATE
Tidsramme: 24 months
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Heart rate measurement is performed with an activity wristband.
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24 months
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TROPONIN I
Tidsramme: 24 months
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The troponin I level is obtained through a blood test.
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24 months
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BLOOD TROPONIN T LEVELS
Tidsramme: 24 months
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The troponin I level is obtained through a blood test.
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24 months
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Broadband ultrasonic attenuation, BUA
Tidsramme: 24 months
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The measurement of the ultrasonic band attenuation (BUA) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.
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24 months
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Ultrasonic wave propagation speed, SOS
Tidsramme: 24 months
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The measurement of ultrasonic wave propagation speed (SOS) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.
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24 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Javier Sánchez Sánchez, Full, European University of Madrid
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UA-2021-03-27
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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