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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Body Weight; Diet, Healthy; Machine Learning; Cholesterol; Lipidosis
• Intervention / Treatment: Behavioral: CONTROL GROUP; Behavioral: HEALTH APP GROUP

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Nutrición Selecta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women over 21 years of age

Exclusion Criteria:

• Volunteers who do not have access to a smartphone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CONTROL GROUP; Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity.	Behavioral: CONTROL GROUP; Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.
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.	Behavioral: HEALTH APP GROUP; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alicante
• Investigators: Principal Investigator: Javier Sánchez Sánchez, Full, European University of Madrid

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Body Weight; Lipidoses
• Other Study ID Numbers: UA-2021-03-27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No