An interventional study of CONTROL GROUP and HEALTH APP GROUP in Hypertension, Diet, Healthy and Body Weight, sponsored by University of Alicante. Completed at 1 site in Spain. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-03.
Sponsored by University of Alicante · Not applicable, Interventional, and Prevention
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 70 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Alicante is the lead sponsor of 28 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity.
Behavioral: CONTROL 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
Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.
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.
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
Time frame: 24 months
HEIGHT
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
Time frame: 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.
Time frame: 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.
Time frame: 24 months
CHOLESTEROL
The blood cholesterol level is obtained through a blood test.
Time frame: 24 months
TRIGLICERIDES
The blood triglicerides level is obtained through a blood test.
Time frame: 24 months
BLOOD PREASURE
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Time frame: 24 months
FAT MASS
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
Time frame: 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.
Time frame: 24 months
VISCERAL FAT
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
Time frame: 24 months
HEART RATE
Heart rate measurement is performed with an activity wristband.
Time frame: 24 months
TROPONIN I
The troponin I level is obtained through a blood test.
Time frame: 24 months
BLOOD TROPONIN T LEVELS
The troponin I level is obtained through a blood test.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Ran from Jul 2020 to primary completion in Dec 2021, 17 months.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 17 months is below that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University of Alicante