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

Not Applicable

Completed

• Conditions: Body Weight; Machine Learning; Cholesterol; Lipidosis; Hypertension; Diet, Healthy; Obesity
• Interventions: Behavioral: CONTROL GROUP; Behavioral: HEALTH APP GROUP

• Registration Number: NCT05093803
• Lead Sponsor: University of Alicante

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Men and women over 21 years of age

Exclusion Criteria

• Volunteers who do not have access to a smartphone.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CONTROL GROUP	CONTROL GROUP	Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity.
APP GROUP	HEALTH 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.

Primary Outcome Measures

Name	Time	Method
CHOLESTEROL	24 months	The blood cholesterol level is obtained through a blood test.
BLOOD PREASURE	24 months	Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Ultrasonic wave propagation speed, SOS	24 months	The measurement of ultrasonic wave propagation speed (SOS) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT	24 months	The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
HEIGHT	24 months	The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
WAIST CIRCUMFERENCE	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.
FAT MASS	24 months	Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
TROPONIN I	24 months	The troponin I level is obtained through a blood test.
BLOOD TROPONIN T LEVELS	24 months	The troponin I level is obtained through a blood test.
HIP CIRCUMFERENCE	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.
TRIGLICERIDES	24 months	The blood triglicerides level is obtained through a blood test.
LEAN BODY MASS	24 months	Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of lean body mass.
VISCERAL FAT	24 months	Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
HEART RATE	24 months	Heart rate measurement is performed with an activity wristband.
Broadband ultrasonic attenuation, BUA	24 months	The measurement of the ultrasonic band attenuation (BUA) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.

Trial Locations

Locations (1)

Nutrición Selecta; 🇪🇸 Elche, Alicante, Spain