HypertensionNCT04828655
Analysis of Bioparametric Measures for Correlating Daily Habits and Reducing Blood Pressure
A study testing Use of a mobile application based on machine learning with the aim of improving health and body composition parameters. in people with Hypertension and Diet, Mediterranean, run by University of Alicante at 1 site in Spain.
Trial summary
To study the effects of the use of a mobile application plus recommendations based on a Mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in a Spanish adult population. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diet, Mediterranean, Cardiovascular Diseases
- What is being tested?
- Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 40 years old
- Healthy.
- Blood pressure levels slightly elevated but less than 140 mm Hg and/or diastolic pressure less than 90 mm Hg.
- Smartphone access
Who cannot join
- Subjects with diseases.
- Consumption of drugs and/or supplements.
- Subjects with food intolerances/allergies.
- Subjects with muscle or joint injury.
- Subjects with impossibility to follow up the intervention.
- Refusal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Análisis de Medidas bioparamétricas Para Correlacionar Los hábitos Diarios y Reducir la tensión Arterial
To study the effects of the use of a mobile application plus recommendations based on a Mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in a Spanish adult population.
Read the detailed description
In the Valencian Community, 93% of deaths appear to be related to (non-communicable) diseases such as: obesity, hypertension and diabetes. In 2013, cardiovascular diseases were the leading cause of death in women (34.4%) and the second in men (28.0%). There is a forecast that overweight and obesity will reach levels of 89% and 85% in men and women, respectively, by 2030. This will result in an increase in the obesity-related prevalence of coronary heart disease by 97%. The promotion of research on arterial hypertension and how it could be reduced is one of the basic pillars in decreasing the prevalence and incidence in the Spanish population. Research should anticipate and develop treatments and vaccines that prevent new scenarios of widespread infection.
Therefore, the main objective is to study the effects of the use of a mobile application plus recommendations based on a Mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in the adult Spanish population.
- Conditions
- Hypertension, Diet, Mediterranean, Cardiovascular Diseases, Exercise, Machine Learning, Overweight and Obesity
- Being tested
- Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Motor Activity, Overweight, Obesity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity. Specific micronutrient intake focused on improving cardiovascular parameters and body composition. |
| EXPERIMENTAL GROUP | Experimental | Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity through an application based on machine learning. Intake of specific micronutrients focused on improving cardiovascular parameters and body composition. Receives: Behavioral: Use of a mobile application based on machine learning with the aim of improving health and body composition parameters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular variables; heart rate.
Heart rate measurement done with an activity wristband.
Measured: 9 months
Cardiovascular variables; blood pressure.
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Measured: 9 months
Physical condition; time.
The evaluation of the physical condition will be carried out by means of the mile test, in which the subjects have to cover this distance walking, and in the shortest possible time.
Measured: 9 months
Body Composition - Bioimpedance
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass, fat-free mass and visceral mass.
Measured: 9 months
Weight
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan). From the body mass and height data, the BMI (kg/m2) will be obtained.
Measured: 9 months
Height
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany). From the body mass and height data, the BMI (kg/m2) will be obtained.
Measured: 9 months
Body Composition - Skinfolds
The kinanthropometric assessment will be carried out using the methodology proposed for the restricted profile by the International Society for the Development of Kineanthropometry (ISAK). The material used to measure skinfolds will be a plicometer.
Measured: 9 months
Body Composition - Perimeters
The kinanthropometric assessment will be carried out using the methodology proposed for the restricted profile by the International Society for the Development of Kineanthropometry (ISAK). The material used to measure perimeters will be a tape.
Measured: 9 months
Body Composition - Diameters
The kinanthropometric assessment will be carried out using the methodology proposed for the restricted profile by the International Society for the Development of Kineanthropometry (ISAK). The material used to measure diameters will be a pachymeter.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Sep 2020
- Primary completion7 Jan 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
- Investigators
- Alejandro Martínez Rodríguez, Principal investigator, Alicante University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828655
- Sponsor's protocol ID
- UA-2020-04-16
- Status last verified
- Sep 2021
- First submitted
- 23 Mar 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Análisis de Medidas bioparamétricas Para Correlacionar Los hábitos Diarios y Reducir la tensión Arterial
- ClinicalTrials.gov ID
- NCT04828655
- Acronym / sponsor ID
- UA-2020-04-16
- Conditions
- Hypertension, Diet, Mediterranean, Cardiovascular Diseases, Exercise, Machine Learning, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the effects of the use of a mobile application plus recommendations based on a Mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in a Spanish adult population.
Detailed description
In the Valencian Community, 93% of deaths appear to be related to (non-communicable) diseases such as: obesity, hypertension and diabetes. In 2013, cardiovascular diseases were the leading cause of death in women (34.4%) and the second in men (28.0%). There is a forecast that overweight and obesity will reach levels of 89% and 85% in men and women, respectively, by 2030. This will result in an increase in the obesity-related prevalence of coronary heart disease by 97%. The promotion of research on arterial hypertension and how it could be reduced is one of the basic pillars in decreasing the prevalence and incidence in the Spanish population. Research should anticipate and develop treatments and vaccines that prevent new scenarios of widespread infection.
Therefore, the main objective is to study the effects of the use of a mobile application plus recommendations based on a Mediterranean diet on the intake of micronutrients from natural sources (not drugs) on health indicators, cardiovascular parameters (blood pressure...), physical condition and body composition in the adult Spanish population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity. Specific micronutrient intake focused on improving cardiovascular parameters and body composition. |
| EXPERIMENTAL GROUP | Experimental | Behavioral: Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity through an application based on machine learning. Intake of specific micronutrients focused on improving cardiovascular parameters and body composition. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 40 years old
- Healthy.
- Blood pressure levels slightly elevated but less than 140 mm Hg and/or diastolic pressure less than 90 mm Hg.
- Smartphone access
Key exclusion criteria (6 listed)
- Subjects with diseases.
- Consumption of drugs and/or supplements.
- Subjects with food intolerances/allergies.
- Subjects with muscle or joint injury.
- Subjects with impossibility to follow up the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.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. | Behavioural | EXPERIMENTAL GROUP |
Primary outcome
Cardiovascular variables; heart rate.
Time frame: 9 months
Heart rate measurement done with an activity wristband.
Cardiovascular variables; blood pressure.
Time frame: 9 months
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Physical condition; time.
Time frame: 9 months
The evaluation of the physical condition will be carried out by means of the mile test, in which the subjects have to cover this distance walking, and in the shortest possible time.
Body Composition - Bioimpedance
Time frame: 9 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass, fat-free mass and visceral mass.
Weight
Time frame: 9 months
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan). From the body mass and height data, the BMI (kg/m2) will be obtained.
Height
Time frame: 9 months
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany). From the body mass and height data, the BMI (kg/m2) will be obtained.
Body Composition - Skinfolds
Time frame: 9 months
The kinanthropometric assessment will be carried out using the methodology proposed for the restricted profile by the International Society for the Development of Kineanthropometry (ISAK). The material used to measure skinfolds will be a plicometer.
Body Composition - Perimeters
Time frame: 9 months
The kinanthropometric assessment will be carried out using the methodology proposed for the restricted profile by the International Society for the Development of Kineanthropometry (ISAK). The material used to measure perimeters will be a tape.
Body Composition - Diameters
Time frame: 9 months
The kinanthropometric assessment will be carried out using the methodology proposed for the restricted profile by the International Society for the Development of Kineanthropometry (ISAK). The material used to measure diameters will be a pachymeter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Martínez Rodríguez principal investigator
Alicante University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of a mobile application based on machine learning with the aim of improving health and body composition parameters. in people with Hypertension and Diet, Mediterranean, run by University of Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular variables; heart rate. (time frame: 9 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.