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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093803
• Other study ID #: UA-2021-03-27
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2022
• Source: University of Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Men and women over 21 years of age

Exclusion Criteria:

• Volunteers who do not have access to a smartphone.

Related Conditions & MeSH terms

• Body Weight
• Cholesterol; Lipidosis
• Diet, Healthy
• Hypertension
• Machine Learning
• Obesity

Intervention

Behavioral:
• CONTROL GROUP
Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.
• 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.

Locations

Country	Name	City	State
Spain	Nutrición Selecta	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT	The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).	24 months
Primary	HEIGHT	The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).	24 months
Primary	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
Primary	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
Primary	CHOLESTEROL	The blood cholesterol level is obtained through a blood test.	24 months
Primary	TRIGLICERIDES	The blood triglicerides level is obtained through a blood test.	24 months
Primary	BLOOD PREASURE	Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.	24 months
Primary	FAT MASS	Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.	24 months
Primary	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
Primary	VISCERAL FAT	Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.	24 months
Primary	HEART RATE	Heart rate measurement is performed with an activity wristband.	24 months
Primary	TROPONIN I	The troponin I level is obtained through a blood test.	24 months
Primary	BLOOD TROPONIN T LEVELS	The troponin I level is obtained through a blood test.	24 months
Primary	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
Primary	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