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

NCT05093803 | Completed DMC

• 1 other identifier: UA-2021-03-27
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

CONTROL GROUP

ACTIVE COMPARATOR

Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity.

Behavioral: CONTROL GROUP

APP GROUP

EXPERIMENTAL

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

Interventions

CONTROL GROUP BEHAVIORAL

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

CONTROL GROUP

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.

Also known as: Nutritional and physical activity intervention through the use of an app.

APP GROUP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women over 21 years of age

You may not qualify if:

• Volunteers who do not have access to a smartphone.

Sponsors & Collaborators

• University of Alicante: lead

Study Sites (1)

Nutrición Selecta

Elche, Alicante, 03202, Spain

Location

MeSH Terms

Conditions

Hypertension; Body Weight; Obesity; Lipidoses

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Javier Sánchez Sánchez, Full

  European University of Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 26, 2021
• Study Start: July 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

ES (1)