- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Alicante
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Elche, Alicante, Espanha, 03202
- Nutrición Selecta
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Men and women over 21 years of age
Exclusion Criteria:
- Volunteers who do not have access to a smartphone.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 24 months
|
Heart rate measurement is performed with an activity wristband.
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24 months
|
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TROPONIN I
Prazo: 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
Prazo: 24 months
|
The troponin I level is obtained through a blood test.
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24 months
|
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Broadband ultrasonic attenuation, BUA
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UA-2021-03-27
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