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Improvement of Physical and Physiological Parameters Through the Use of a Mobile App

30. september 2022 oppdatert av: Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante

Study of Physical and Physiological Changes Through the Use of a Mobile App That Promotes Healthy Habits

To investigate the health effects of a new mobile application (app) for prevention and personalized treatment in people with chronic cardiovascular pathologies associated with body composition.

Studieoversikt

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

Intervensjonell

Registrering (Faktiske)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Alicante
      • Elche, Alicante, Spania, 03202
        • Nutrición Selecta

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Men and women over 21 years of age

Exclusion Criteria:

  • Volunteers who do not have access to a smartphone.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: CONTROL GROUP
Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity.
Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.
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.

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:
  • Nutritional and physical activity intervention through the use of an app.

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).
24 months
HEIGHT
Tidsramme: 24 months
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
24 months
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.
24 months
HIP 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.
24 months
CHOLESTEROL
Tidsramme: 24 months
The blood cholesterol level is obtained through a blood test.
24 months
TRIGLICERIDES
Tidsramme: 24 months
The blood triglicerides level is obtained through a blood test.
24 months
BLOOD PREASURE
Tidsramme: 24 months
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
24 months
FAT MASS
Tidsramme: 24 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
24 months
LEAN BODY MASS
Tidsramme: 24 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of lean body mass.
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.
24 months
TROPONIN I
Tidsramme: 24 months
The troponin I level is obtained through a blood test.
24 months
BLOOD TROPONIN T LEVELS
Tidsramme: 24 months
The troponin I level is obtained through a blood test.
24 months
Broadband ultrasonic attenuation, BUA
Tidsramme: 24 months
The measurement of the ultrasonic band attenuation (BUA) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.
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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Javier Sánchez Sánchez, Full, European University of Madrid

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2020

Primær fullføring (Faktiske)

30. desember 2021

Studiet fullført (Faktiske)

30. desember 2021

Datoer for studieregistrering

Først innsendt

30. september 2021

Først innsendt som oppfylte QC-kriteriene

13. oktober 2021

Først lagt ut (Faktiske)

26. oktober 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. oktober 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2022

Sist bekreftet

1. september 2022

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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