- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Alicante
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Elche, Alicante, Spania, 03202
- Nutrición Selecta
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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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Eksperimentell: 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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
Tidsramme: 24 months
|
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
|
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
|
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.
|
24 months
|
|
CHOLESTEROL
Tidsramme: 24 months
|
The blood cholesterol level is obtained through a blood test.
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24 months
|
|
TRIGLICERIDES
Tidsramme: 24 months
|
The blood triglicerides level is obtained through a blood test.
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24 months
|
|
BLOOD PREASURE
Tidsramme: 24 months
|
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
|
|
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
|
|
VISCERAL FAT
Tidsramme: 24 months
|
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
|
24 months
|
|
HEART RATE
Tidsramme: 24 months
|
Heart rate measurement is performed with an activity wristband.
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24 months
|
|
TROPONIN I
Tidsramme: 24 months
|
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
|
The troponin I level is obtained through a blood test.
|
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
|
|
Ultrasonic wave propagation speed, SOS
Tidsramme: 24 months
|
The measurement of ultrasonic wave propagation speed (SOS) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.
|
24 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Javier Sánchez Sánchez, Full, European University of Madrid
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UA-2021-03-27
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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