- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Alicante
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Elche, Alicante, Spagna, 03202
- Nutrición Selecta
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Men and women over 21 years of age
Exclusion Criteria:
- Volunteers who do not have access to a smartphone.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
|
CHOLESTEROL
Lasso di tempo: 24 months
|
The blood cholesterol level is obtained through a blood test.
|
24 months
|
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TRIGLICERIDES
Lasso di tempo: 24 months
|
The blood triglicerides level is obtained through a blood test.
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24 months
|
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BLOOD PREASURE
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
|
HEART RATE
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Javier Sánchez Sánchez, Full, European University of Madrid
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UA-2021-03-27
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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