- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alicante
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Elche, Alicante, España, 03202
- Nutrición Selecta
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Men and women over 21 years of age
Exclusion Criteria:
- Volunteers who do not have access to a smartphone.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Experimental: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Javier Sánchez Sánchez, Full, European University of Madrid
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UA-2021-03-27
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .