Improvement of Physical and Physiological Parameters Through the Use of a Mobile App
Primary Purpose
Hypertension, Diet, Healthy, Body Weight
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CONTROL GROUP
HEALTH APP GROUP
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Men and women over 21 years of age
Exclusion Criteria:
- Volunteers who do not have access to a smartphone.
Sites / Locations
- Nutrición Selecta
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CONTROL GROUP
APP GROUP
Arm Description
Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity.
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.
Outcomes
Primary Outcome Measures
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
HEIGHT
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
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.
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.
CHOLESTEROL
The blood cholesterol level is obtained through a blood test.
TRIGLICERIDES
The blood triglicerides level is obtained through a blood test.
BLOOD PREASURE
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
FAT MASS
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
LEAN BODY MASS
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of lean body mass.
VISCERAL FAT
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
HEART RATE
Heart rate measurement is performed with an activity wristband.
TROPONIN I
The troponin I level is obtained through a blood test.
BLOOD TROPONIN T LEVELS
The troponin I level is obtained through a blood test.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05093803
First Posted
September 30, 2021
Last Updated
September 30, 2022
Sponsor
University of Alicante
1. Study Identification
Unique Protocol Identification Number
NCT05093803
Brief Title
Improvement of Physical and Physiological Parameters Through the Use of a Mobile App
Official Title
Study of Physical and Physiological Changes Through the Use of a Mobile App That Promotes Healthy Habits
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alicante
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diet, Healthy, Body Weight, Obesity, Cholesterol; Lipidosis, Machine Learning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity.
Arm Title
APP GROUP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CONTROL GROUP
Intervention Description
Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.
Intervention Type
Behavioral
Intervention Name(s)
HEALTH APP GROUP
Other Intervention Name(s)
Nutritional and physical activity intervention through the use of an app.
Intervention Description
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.
Primary Outcome Measure Information:
Title
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
Description
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
Time Frame
24 months
Title
HEIGHT
Description
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
Time Frame
24 months
Title
WAIST CIRCUMFERENCE
Description
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.
Time Frame
24 months
Title
HIP CIRCUMFERENCE
Description
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.
Time Frame
24 months
Title
CHOLESTEROL
Description
The blood cholesterol level is obtained through a blood test.
Time Frame
24 months
Title
TRIGLICERIDES
Description
The blood triglicerides level is obtained through a blood test.
Time Frame
24 months
Title
BLOOD PREASURE
Description
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Time Frame
24 months
Title
FAT MASS
Description
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
Time Frame
24 months
Title
LEAN BODY MASS
Description
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of lean body mass.
Time Frame
24 months
Title
VISCERAL FAT
Description
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
Time Frame
24 months
Title
HEART RATE
Description
Heart rate measurement is performed with an activity wristband.
Time Frame
24 months
Title
TROPONIN I
Description
The troponin I level is obtained through a blood test.
Time Frame
24 months
Title
BLOOD TROPONIN T LEVELS
Description
The troponin I level is obtained through a blood test.
Time Frame
24 months
Title
Broadband ultrasonic attenuation, BUA
Description
The measurement of the ultrasonic band attenuation (BUA) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.
Time Frame
24 months
Title
Ultrasonic wave propagation speed, SOS
Description
The measurement of ultrasonic wave propagation speed (SOS) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women over 21 years of age
Exclusion Criteria:
Volunteers who do not have access to a smartphone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Sánchez Sánchez, Full
Organizational Affiliation
European University of Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrición Selecta
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
12. IPD Sharing Statement
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Improvement of Physical and Physiological Parameters Through the Use of a Mobile App
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