HypertensionNCT05093803
Improvement of Physical and Physiological Parameters Through the Use of a Mobile App
A study testing HEALTH APP GROUP in people with Hypertension and Diet, Healthy, run by University of Alicante at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diet, Healthy, Body Weight
- What is being tested?
- HEALTH APP GROUP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2020to 30 Dec 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women over 21 years of age
Who cannot join
- Volunteers who do not have access to a smartphone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Physical and Physiological Changes Through the Use of a Mobile App That Promotes Healthy Habits
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.
Read the 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.
- Conditions
- Hypertension, Diet, Healthy, Body Weight, Obesity, Cholesterol; Lipidosis, Machine Learning
- Being tested
- CONTROL GROUP, HEALTH APP GROUP
- Medical subject headings
- Hypertension, Body Weight, Obesity, Lipidoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTROL GROUPBehavioural
Intervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations.
HEALTH APP GROUPBehavioural
Also called Nutritional and physical activity intervention through the use of an app.
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.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | Active comparator | Recommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity. Receives: 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. Receives: Behavioral: HEALTH APP GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
Measured: 24 months
HEIGHT
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
Measured: 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.
Measured: 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.
Measured: 24 months
CHOLESTEROL
The blood cholesterol level is obtained through a blood test.
Measured: 24 months
TRIGLICERIDES
The blood triglicerides level is obtained through a blood test.
Measured: 24 months
BLOOD PREASURE
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
Measured: 24 months
FAT MASS
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
Measured: 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.
Measured: 24 months
VISCERAL FAT
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
Measured: 24 months
HEART RATE
Heart rate measurement is performed with an activity wristband.
Measured: 24 months
TROPONIN I
The troponin I level is obtained through a blood test.
Measured: 24 months
BLOOD TROPONIN T LEVELS
The troponin I level is obtained through a blood test.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Jul 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 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
- Javier Sánchez Sánchez, Full, Principal investigator, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093803
- Sponsor's protocol ID
- UA-2021-03-27
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2021
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Physical and Physiological Changes Through the Use of a Mobile App That Promotes Healthy Habits
- ClinicalTrials.gov ID
- NCT05093803
- Acronym / sponsor ID
- UA-2021-03-27
- Conditions
- Hypertension, Diet, Healthy, Body Weight, Obesity, Cholesterol; Lipidosis, Machine Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 26 Oct 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | Active comparator | Behavioral: CONTROL GROUPRecommendations on healthy eating habits based on the Mediterranean diet and moderate physical activity. |
| APP GROUP | Experimental | Behavioral: HEALTH APP GROUPRecommendations 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women over 21 years of age
Key exclusion criteria (1 listed)
- Volunteers who do not have access to a smartphone.
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 |
|---|---|---|
| CONTROL GROUPIntervention based on measurements of health parameters before and after providing participants with personalized dietary and physical activity recommendations. | Behavioural | CONTROL GROUP |
| HEALTH APP GROUPAlso: Nutritional and physical activity intervention through the use of an app.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. | Behavioural | APP GROUP |
Primary outcome
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT
Time frame: 24 months
The weight of the subjects will be obtained using the TANITA (Tokyo, Japan).
HEIGHT
Time frame: 24 months
The height of the subjects will be measured with the SECA 123 stadiometer (Hamburg, Germany).
WAIST CIRCUMFERENCE
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
The blood cholesterol level is obtained through a blood test.
TRIGLICERIDES
Time frame: 24 months
The blood triglicerides level is obtained through a blood test.
BLOOD PREASURE
Time frame: 24 months
Measurement of blood pressure (systolic and diastolic) with a digital tensiometer.
FAT MASS
Time frame: 24 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of fat mass.
LEAN BODY MASS
Time frame: 24 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of lean body mass.
VISCERAL FAT
Time frame: 24 months
Assessment of body composition using the TANITA (Tokyo, Japan) validated bioimpedance scale to obtain the results of visceral fat.
HEART RATE
Time frame: 24 months
Heart rate measurement is performed with an activity wristband.
TROPONIN I
Time frame: 24 months
The troponin I level is obtained through a blood test.
BLOOD TROPONIN T LEVELS
Time frame: 24 months
The troponin I level is obtained through a blood test.
Broadband ultrasonic attenuation, BUA
Time frame: 24 months
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
Time frame: 24 months
The measurement of ultrasonic wave propagation speed (SOS) by the traversed bone tissue (calcaneus) is performed using the GE Achilles Insight device.
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 3 Oct 2022.
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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.
Javier Sánchez Sánchez, Full principal investigator
European University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEALTH APP GROUP in people with Hypertension and Diet, Healthy, 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 1 inclusion and 1 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 3 Oct 2022. 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?
WEIGHT WEIGHT WEIGHT WEIGHT WEIGHT (time frame: 24 months). The study lists 15 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 3 Oct 2022.