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Completed

NCT Number: NCT05093803

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

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.

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Key information

Conditions

Hypertension Body Weight Cardiovascular Diseases Cholesterol; Lipidosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diet, Healthy Genetic Diseases, Inborn Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Machine Learning Metabolic Diseases Metabolism, Inborn Errors Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrición Selecta

Elche, Alicante, 03202, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women over 21 years of age

Exclusion criteria

  • Volunteers who do not have access to a smartphone.

Treatment and study plan

Control Group

Behavioral

Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.

HEALTH APP GROUP

Behavioral

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.

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

Primary outcomes

  1. WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT

    Time frame: 24 months

    The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).

  2. HEIGHT

    Time frame: 24 months

    The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).

  3. WAIST CIRCUMFERENCE

    Time frame: 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.

  4. HIP CIRCUMFERENCE

    Time frame: 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.

  5. CHOLESTEROL

    Time frame: 24 months

    The blood cholesterol level is obtained through a blood test.

  6. TRIGLICERIDES

    Time frame: 24 months

    The blood triglicerides level is obtained through a blood test.

  7. BLOOD PREASURE

    Time frame: 24 months

    Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.

  8. FAT MASS

    Time frame: 24 months

    Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.

  9. LEAN BODY MASS

    Time frame: 24 months

    Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of lean body mass.

  10. VISCERAL FAT

    Time frame: 24 months

    Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.

  11. HEART RATE

    Time frame: 24 months

    Heart rate measurement is performed with an activity wristband.

  12. TROPONIN I

    Time frame: 24 months

    The troponin I level is obtained through a blood test.

  13. BLOOD TROPONIN T LEVELS

    Time frame: 24 months

    The troponin I level is obtained through a blood test.

  14. Broadband ultrasonic attenuation, BUA

    Time frame: 24 months

    The measurement of the ultrasonic band attenuation (BUA) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.

  15. Ultrasonic wave propagation speed, SOS

    Time frame: 24 months

    The measurement of ultrasonic wave propagation speed (SOS) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2021
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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