LifestyleMedLIFENCT06601478
Development and Implementation of a Tool for the Evaluation and Monitoring of the Mediterranean Lifestyle in the Clinical Setting
A study testing The MedLIFE app in people with Lifestyle, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The main goal is to develop a health online app based on a Mediterranean lifestyle score (diet, cooking preferences, rest, physical activity, social habits, conviviality) and its implementation in clinical settings with patients that have suffered from a cardiovascular event. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lifestyle
- What is being tested?
- The MedLIFE app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- 16 Sep 2024to 6 Oct 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years and below 75 years.
- Absence of language barriers
- To be included in the cardiac rehabilitation programme
- Capacity to comprehend, and answer the questionnaires, as well as to sign the informed consent.
- Being a Spanish resident for a period of at least 1 year prior to the beginning of the study.
- Not planning to permanently reside outside of Spain within the year.
- Having suffered from a cardiovascular event (myocardial infarction, ictus, angina, ischemic cardiopathy).
Who cannot join
- Limitation to adhering to the recommendations.
- Severe risk factors and/or with complicated control.
- Chronic diseases not related to coronary disease (severe mental illness, congenital, susceptible to decompensation endocrinopathies, and gastrointestinal diseases with diarrhoea).
- Patients that have an alternative private health insurance that doesn´t allow an electronic access to their data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Implementation of a Tool for the Evaluation and Monitorization of Mediterranean Lifestyle at Clinical Settings: MEDLIFE Index, a Proof of Concept Study
The main goal is to develop a health online app based on a Mediterranean lifestyle score (diet, cooking preferences, rest, physical activity, social habits, conviviality) and its implementation in clinical settings with patients that have suffered from a cardiovascular event. This is a pilot study that will allow an integral assessment of health as an attempt to decrease obesity, one of the main risk factors of cardiovascular disease, as well as to improve the prevention of secondary events.
The main goal involves the following specific objectives:
Read more
Developing and transferring the previously validated questionnaire in Spanish population (MEDLIFE index, MEDiterranean LIFEstyle) to evaluate adherence to a Mediterranean lifestyle an online app, that allows:
To evaluate and to monitor the adherence to the MEDLIFE throughout time.
To use the MEDLIFE online app to obtain customized recommendations according to the results (an instantaneous generation of a resume of results).
To start conversations between patient and health workers to improve patient's lifestyles, obesity or related parameters and cardiovascular health.
To keep information in a safe way that will allow it to be linked to other health indicators.
Conducting a qualitative study using personal interviews with health providers and patients, to evaluate acceptation, feasibility, barriers, or limitations when using the MEDLIFE app in clinical practice, aiming for the app's enhancing.
Conducting a pilot study of implementation of MEDLIFE in clinical settings, in patients with a cardiovascular event (myocardial infarction, ictus, angina, ischemic cardiopathy) (n= 80-100, trying parity between men and women).
This is the project's intervention part.
To evaluate changes in MEDLIFE and its components, anthropometric and biochemical measurements between baseline, 3-month, 6-month and 8-month follow-up.
Following participants by means of revision of medical reports and clinical histories to register future cardiovascular events (dynamic).
Read the detailed description
Participants will be selected from the clinical cardiology and cardiac rehabilitation or internal medicine services. Each physician will recruit patients from among those assigned to his or her practice, just as they are discharged from the hospital after a cardiovascular event.
The online application will be suitable for tablet, mobile and web use. For its development, a specialist web/app development company will be contracted and will follow the indications of the research team.
The application, visually attractive, should allow a quick and easy evaluation of MEDLIFE and, in addition, include interactive features that raise awareness and motivate users to change their health habits. Thus, when the participant has completed the questionnaire, a results page will be automatically generated with a color scale to indicate what needs to be improved (red, indicating a factor to be considered for improvement; green, the recommendations are met and the participant is performing adequately). Also, specific recommendations will be provided to achieve the objectives of those factors that can be improved. In this way, the results will be ready to be evaluated and discussed with the healthcare professional. The design of the app will be inclusive to allow the use of the app by people with certain disabilities (it will allow the questions to be read by a voice (audio), for people with disabilities, vision loss or illiterate). This objective will be carried out with the help of a computer technician specialized in the development of mobile applications and web pages.
In addition, physicians will be able to monitor their patients at each visit, entering themselves the data obtained from MEDLIFE as well as anthropometric and analytical parameters. All this information entered into the app will be available for research use by the researchers for the project, in an anonymized form.
The data will be stored in a secure, password-protected Firebase system to allow data analysis and tracking. A consent, medical disclaimer and privacy policy will be included in the app.
- Conditions
- Lifestyle
- Being tested
- The MedLIFE app
- Keywords
- Lifestyle behaviours, Cardiovascular disease, Cardiovascular event, Intervention, Health App, Prevention, Mediterranean Diet
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MedLIFE appBehavioural
The intervention arm will receive the lifestyle counselling by the MEDLIFE app, and the control arm will go on with standard lifestyle recommendations in the form of a two-page written handout.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Participants will undergo the MEDLIFE evaluation and will talk over their results and recommendations with the health care providers (cardiologists, nurses or dietitians) to improve habits identified as inadequate.
The intervention group will obtain access to the MEDLIFE online app and will receive personal text messages based on the MEDLIFE test to improve each of the items included in the tool. The available resources will be based on the recommendations for diet, physical activity, sleep and social interaction.
At the beginning and in each of the 4 visits, the following determinations will be done in both groups: anthropometric and biochemical measurements by trained stuff, arterial pressure, MEDLIFE scoring, sociodemographic questions, several questionnaires, and other relevant information obtained from medical histories. Receives: Behavioral: The MedLIFE app |
| Control, no Lifestyle Intervention | No intervention | Participants will undergo the MEDLIFE evaluation and will talk over their results and recommendations with the health care providers (cardiologists, nurses or dietitians) to improve habits identified as inadequate. The control group will continue with their current lifestyle and will receive a handout with lifestyle recommendations. At the beginning and in each of the 4 visits, the following determinations will be done in both groups: anthropometric and biochemical measurements by trained stuff, arterial pressure, MEDLIFE scoring, sociodemographic questions, several questionnaires, and other relevant information obtained from medical histories. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Mediterranean Lifestyle Index (MedLIFE)
The primary outcome will be an increased adherence to the MedLIFE Index (0-28 points), indicating better adherence to the Mediterranean lifestyle. Participants in the intervention group will aim to enhance diet quality with moderate caloric restriction, engage in at least 150 minutes of moderate-intensity physical activity weekly, sleep 6-8 hours nightly with naps as needed, and increase resilience through positive social connections to manage stress.
Measured: 6-8 months
Changes in intermediate lipid biomarkers of CVD
Changes in cardiovascular disease biomarkers measured through blood and urine tests:
- Total cholesterol mg/dL
- Low-density lipoprotein cholesterol mg/dL
- Non-high-density, cholesterol mg/dL
- High -density lipoprotein cholesterol mg/dL
- Apolipoprotein B mg/dL
- Triglycerides mg/dL
- Remnant cholesterol mg/dL
- Lipoprotein(a) mg/dL
- Fraction of lipoprotein(a) mg/dL
Measured: 6-8 months
Changes in intermediate biomarkers of CVD: blood pressure
Changes in blood pressure, other biomarkers of CVD:
- Systolic blood pressure (mmHg)
- Diastolic blood pressure (mmHg)
Measured: 6-8 months
Changes in intermediate biomakers of CVD: glucose metabolism
Changes in glycated hemoglobin %
Measured: 6-8 months
Changes in anthropometric metrics: hip and waist circunference (cm)
Changes in:
- Hip circunference (cm)
- Waist circunference (cm)
Measured: 6-8 months
Changes in anthropometric metrics: BMI
Body mass index (BMI): measured by weight (Kg) and height (m²) combined
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Sep 2024
- Primary completion1 Sep 2026
- Study completion6 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for LifestyleStudies 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
- Parallel groups
- Model description
- The intervention group will complete de MEDLIFE questionnaire and use the MEDLIFE online app where they will receive counselling on lifestyle, food choices or physical activity. Meanwhile, the control group will only complete the MEDLIFE questionnaire, but will not receive the app lifestyle intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Juan Ramón Jiménez
- Responsible party
- Principal investigator, Mercedes Sotos Prieto, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601478
- Sponsor's protocol ID
- CNS2022-135623
- Acronym
- MedLIFE
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hernaez A, Zomeno MD, Degano IR, Perez-Fernandez S, Goday A, Vila J, Civeira F, Moure R, Marrugat J. Excess Weight in Spain: Current Situation, Projections for 2030, and Estimated Direct Extra Cost for the Spanish Health System. Rev Esp Cardiol (Engl Ed). 2019 Nov;72(11):916-924. doi: 10.1016/j.rec.2018.10.010. Epub 2018 Nov 23. English, Spanish.
PubMed 30473259Williamson EJ, Walker AJ, Bhaskaran K, Bacon S, Bates C, Morton CE, Curtis HJ, Mehrkar A, Evans D, Inglesby P, Cockburn J, McDonald HI, MacKenna B, Tomlinson L, Douglas IJ, Rentsch CT, Mathur R, Wong AYS, Grieve R, Harrison D, Forbes H, Schultze A, Croker R, Parry J, Hester F, Harper S, Perera R, Evans SJW, Smeeth L, Goldacre B. Factors associated with COVID-19-related death using OpenSAFELY. Nature. 2020 Aug;584(7821):430-436. doi: 10.1038/s41586-020-2521-4. Epub 2020 Jul 8.
PubMed 32640463Esposito K, Kastorini CM, Panagiotakos DB, Giugliano D. Mediterranean diet and metabolic syndrome: an updated systematic review. Rev Endocr Metab Disord. 2013 Sep;14(3):255-63. doi: 10.1007/s11154-013-9253-9.
PubMed 23982678InterAct Consortium; Romaguera D, Guevara M, Norat T, Langenberg C, Forouhi NG, Sharp S, Slimani N, Schulze MB, Buijsse B, Buckland G, Molina-Montes E, Sanchez MJ, Moreno-Iribas MC, Bendinelli B, Grioni S, van der Schouw YT, Arriola L, Beulens JW, Boeing H, Clavel-Chapelon F, Cottet V, Crowe FL, de Lauzon-Guillan B, Franks PW, Gonzalez C, Hallmans G, Kaaks R, Key TJ, Khaw K, Nilsson P, Overvad K, Palla L, Palli D, Panico S, Quiros JR, Rolandsson O, Romieu I, Sacerdote C, Spijkerman AM, Teucher B, Tjonneland A, Tormo MJ, Tumino R, van der AD, Feskens EJ, Riboli E, Wareham NJ. Mediterranean diet and type 2 diabetes risk in the European Prospective Investigation into Cancer and Nutrition (EPIC) study: the InterAct project. Diabetes Care. 2011 Sep;34(9):1913-8. doi: 10.2337/dc11-0891. Epub 2011 Jul 25.
PubMed 21788627Esposito K, Maiorino MI, Bellastella G, Chiodini P, Panagiotakos D, Giugliano D. A journey into a Mediterranean diet and type 2 diabetes: a systematic review with meta-analyses. BMJ Open. 2015 Aug 10;5(8):e008222. doi: 10.1136/bmjopen-2015-008222.
PubMed 26260349Echeverria G, McGee EE, Urquiaga I, Jimenez P, D'Acuna S, Villarroel L, Velasco N, Leighton F, Rigotti A. Inverse Associations between a Locally Validated Mediterranean Diet Index, Overweight/Obesity, and Metabolic Syndrome in Chilean Adults. Nutrients. 2017 Aug 11;9(8):862. doi: 10.3390/nu9080862.
PubMed 28800091Sotos-Prieto M, Bhupathiraju SN, Mattei J, Fung TT, Li Y, Pan A, Willett WC, Rimm EB, Hu FB. Changes in Diet Quality Scores and Risk of Cardiovascular Disease Among US Men and Women. Circulation. 2015 Dec 8;132(23):2212-9. doi: 10.1161/CIRCULATIONAHA.115.017158. Epub 2015 Oct 5.
PubMed 26644246Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Fito M, Gea A, Hernan MA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. 2018 Jun 21;378(25):e34. doi: 10.1056/NEJMoa1800389. Epub 2018 Jun 13.
PubMed 29897866Schwingshackl L, Schwedhelm C, Galbete C, Hoffmann G. Adherence to Mediterranean Diet and Risk of Cancer: An Updated Systematic Review and Meta-Analysis. Nutrients. 2017 Sep 26;9(10):1063. doi: 10.3390/nu9101063.
PubMed 28954418Sotos-Prieto M, Bhupathiraju SN, Mattei J, Fung TT, Li Y, Pan A, Willett WC, Rimm EB, Hu FB. Association of Changes in Diet Quality with Total and Cause-Specific Mortality. N Engl J Med. 2017 Jul 13;377(2):143-153. doi: 10.1056/NEJMoa1613502.
PubMed 28700845Soltani S, Jayedi A, Shab-Bidar S, Becerra-Tomas N, Salas-Salvado J. Adherence to the Mediterranean Diet in Relation to All-Cause Mortality: A Systematic Review and Dose-Response Meta-Analysis of Prospective Cohort Studies. Adv Nutr. 2019 Nov 1;10(6):1029-1039. doi: 10.1093/advances/nmz041.
PubMed 31111871Delgado-Lista J, Alcala-Diaz JF, Torres-Pena JD, Quintana-Navarro GM, Fuentes F, Garcia-Rios A, Ortiz-Morales AM, Gonzalez-Requero AI, Perez-Caballero AI, Yubero-Serrano EM, Rangel-Zuniga OA, Camargo A, Rodriguez-Cantalejo F, Lopez-Segura F, Badimon L, Ordovas JM, Perez-Jimenez F, Perez-Martinez P, Lopez-Miranda J; CORDIOPREV Investigators. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial. Lancet. 2022 May 14;399(10338):1876-1885. doi: 10.1016/S0140-6736(22)00122-2. Epub 2022 May 4.
PubMed 35525255Kraus WE, Powell KE, Haskell WL, Janz KF, Campbell WW, Jakicic JM, Troiano RP, Sprow K, Torres A, Piercy KL; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity, All-Cause and Cardiovascular Mortality, and Cardiovascular Disease. Med Sci Sports Exerc. 2019 Jun;51(6):1270-1281. doi: 10.1249/MSS.0000000000001939.
PubMed 31095084Aude YW, Agatston AS, Lopez-Jimenez F, Lieberman EH, Marie Almon, Hansen M, Rojas G, Lamas GA, Hennekens CH. The national cholesterol education program diet vs a diet lower in carbohydrates and higher in protein and monounsaturated fat: a randomized trial. Arch Intern Med. 2004 Oct 25;164(19):2141-6. doi: 10.1001/archinte.164.19.2141.
PubMed 15505128Diaz-Gutierrez J, Ruiz-Canela M, Gea A, Fernandez-Montero A, Martinez-Gonzalez MA. Association Between a Healthy Lifestyle Score and the Risk of Cardiovascular Disease in the SUN Cohort. Rev Esp Cardiol (Engl Ed). 2018 Dec;71(12):1001-1009. doi: 10.1016/j.rec.2017.10.038. Epub 2017 Dec 26. English, Spanish.
PubMed 29287797
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of a Tool for the Evaluation and Monitorization of Mediterranean Lifestyle at Clinical Settings: MEDLIFE Index, a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT06601478
- Acronym / sponsor ID
- MedLIFE / CNS2022-135623
- Conditions
- Lifestyle
- Keywords
- Lifestyle behaviours, Cardiovascular disease, Cardiovascular event, Intervention, Health App, Prevention, Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Hospital Universitario Juan Ramón Jiménez
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 6 Oct 2026 (actual)
- First posted
- 19 Sep 2024 (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.
The main goal is to develop a health online app based on a Mediterranean lifestyle score (diet, cooking preferences, rest, physical activity, social habits, conviviality) and its implementation in clinical settings with patients that have suffered from a cardiovascular event. This is a pilot study that will allow an integral assessment of health as an attempt to decrease obesity, one of the main risk factors of cardiovascular disease, as well as to improve the prevention of secondary events.
The main goal involves the following specific objectives:
Developing and transferring the previously validated questionnaire in Spanish population (MEDLIFE index, MEDiterranean LIFEstyle) to evaluate adherence to a Mediterranean lifestyle an online app, that allows:
To evaluate and to monitor the adherence to the MEDLIFE throughout time.
To use the MEDLIFE online app to obtain customized recommendations according to the results (an instantaneous generation of a resume of results).
To start conversations between patient and health workers to improve patient's lifestyles, obesity or related parameters and cardiovascular health.
To keep information in a safe way that will allow it to be linked to other health indicators.
Conducting a qualitative study using personal interviews with health providers and patients, to evaluate acceptation, feasibility, barriers, or limitations when using the MEDLIFE app in clinical practice, aiming for the app's enhancing.
Conducting a pilot study of implementation of MEDLIFE in clinical settings, in patients with a cardiovascular event (myocardial infarction, ictus, angina, ischemic cardiopathy) (n= 80-100, trying parity between men and women).
This is the project's intervention part.
To evaluate changes in MEDLIFE and its components, anthropometric and biochemical measurements between baseline, 3-month, 6-month and 8-month follow-up.
Following participants by means of revision of medical reports and clinical histories to register future cardiovascular events (dynamic).
Detailed description
Participants will be selected from the clinical cardiology and cardiac rehabilitation or internal medicine services. Each physician will recruit patients from among those assigned to his or her practice, just as they are discharged from the hospital after a cardiovascular event.
The online application will be suitable for tablet, mobile and web use. For its development, a specialist web/app development company will be contracted and will follow the indications of the research team.
The application, visually attractive, should allow a quick and easy evaluation of MEDLIFE and, in addition, include interactive features that raise awareness and motivate users to change their health habits. Thus, when the participant has completed the questionnaire, a results page will be automatically generated with a color scale to indicate what needs to be improved (red, indicating a factor to be considered for improvement; green, the recommendations are met and the participant is performing adequately). Also, specific recommendations will be provided to achieve the objectives of those factors that can be improved. In this way, the results will be ready to be evaluated and discussed with the healthcare professional. The design of the app will be inclusive to allow the use of the app by people with certain disabilities (it will allow the questions to be read by a voice (audio), for people with disabilities, vision loss or illiterate). This objective will be carried out with the help of a computer technician specialized in the development of mobile applications and web pages.
In addition, physicians will be able to monitor their patients at each visit, entering themselves the data obtained from MEDLIFE as well as anthropometric and analytical parameters. All this information entered into the app will be available for research use by the researchers for the project, in an anonymized form.
The data will be stored in a secure, password-protected Firebase system to allow data analysis and tracking. A consent, medical disclaimer and privacy policy will be included in the app.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group will complete de MEDLIFE questionnaire and use the MEDLIFE online app where they will receive counselling on lifestyle, food choices or physical activity. Meanwhile, the control group will only complete the MEDLIFE questionnaire, but will not receive the app lifestyle intervention.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: The MedLIFE appParticipants will undergo the MEDLIFE evaluation and will talk over their results and recommendations with the health care providers (cardiologists, nurses or dietitians) to improve habits identified as inadequate. The intervention group will obtain access to the MEDLIFE online app and will receive personal text messages based on the MEDLIFE test to improve each of the items included in the tool. The available resources will be based on the recommendations for diet, physical activity, sleep and social interaction. At the beginning and in each of the 4 visits, the following determinations will be done in both groups: anthropometric and biochemical measurements by trained stuff, arterial pressure, MEDLIFE scoring, sociodemographic questions, several questionnaires, and other relevant information obtained from medical histories. |
| Control, no Lifestyle Intervention | No intervention | –Participants will undergo the MEDLIFE evaluation and will talk over their results and recommendations with the health care providers (cardiologists, nurses or dietitians) to improve habits identified as inadequate. The control group will continue with their current lifestyle and will receive a handout with lifestyle recommendations. At the beginning and in each of the 4 visits, the following determinations will be done in both groups: anthropometric and biochemical measurements by trained stuff, arterial pressure, MEDLIFE scoring, sociodemographic questions, several questionnaires, and other relevant information obtained from medical histories. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age over 18 years and below 75 years.
- Absence of language barriers
- To be included in the cardiac rehabilitation programme
- Capacity to comprehend, and answer the questionnaires, as well as to sign the informed consent.
- Being a Spanish resident for a period of at least 1 year prior to the beginning of the study.
Key exclusion criteria (4 listed)
- Limitation to adhering to the recommendations.
- Severe risk factors and/or with complicated control.
- Chronic diseases not related to coronary disease (severe mental illness, congenital, susceptible to decompensation endocrinopathies, and gastrointestinal diseases with diarrhoea).
- Patients that have an alternative private health insurance that doesn´t allow an electronic access to their data.
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 |
|---|---|---|
| The MedLIFE appThe intervention arm will receive the lifestyle counselling by the MEDLIFE app, and the control arm will go on with standard lifestyle recommendations in the form of a two-page written handout. | Behavioural | Lifestyle Intervention |
Primary outcome
Changes in the Mediterranean Lifestyle Index (MedLIFE)
Time frame: 6-8 months
The primary outcome will be an increased adherence to the MedLIFE Index (0-28 points), indicating better adherence to the Mediterranean lifestyle. Participants in the intervention group will aim to enhance diet quality with moderate caloric restriction, engage in at least 150 minutes of moderate-intensity physical activity weekly, sleep 6-8 hours nightly with naps as needed, and increase resilience through positive social connections to manage stress.
Changes in intermediate lipid biomarkers of CVD
Time frame: 6-8 months
Changes in cardiovascular disease biomarkers measured through blood and urine tests: * Total cholesterol mg/dL * Low-density lipoprotein cholesterol mg/dL * Non-high-density, cholesterol mg/dL * High -density lipoprotein cholesterol mg/dL * Apolipoprotein B mg/dL * Triglycerides mg/dL * Remnant cholesterol mg/dL * Lipoprotein(a) mg/dL * Fraction of lipoprotein(a) mg/dL
Changes in intermediate biomarkers of CVD: blood pressure
Time frame: 6-8 months
Changes in blood pressure, other biomarkers of CVD: * Systolic blood pressure (mmHg) * Diastolic blood pressure (mmHg)
Changes in intermediate biomakers of CVD: glucose metabolism
Time frame: 6-8 months
Changes in glycated hemoglobin %
Changes in anthropometric metrics: hip and waist circunference (cm)
Time frame: 6-8 months
Changes in: * Hip circunference (cm) * Waist circunference (cm)
Changes in anthropometric metrics: BMI
Time frame: 6-8 months
Body mass index (BMI): measured by weight (Kg) and height (m²) combined
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 9 Oct 2026.
- Background: PubMed 30473259Hernaez A, Zomeno MD, Degano IR, Perez-Fernandez S, Goday A, Vila J, Civeira F, Moure R, Marrugat J. Excess Weight in Spain: Current Situation, Projections for 2030, and Estimated Direct Extra Cost for the Spanish Health System. Rev Esp Cardiol (Engl Ed). 2019 Nov;72(11):916-924. doi: 10.1016/j.rec.2018.10.010. Epub 2018 Nov 23. English, Spanish.
- Background: PubMed 32640463Williamson EJ, Walker AJ, Bhaskaran K, Bacon S, Bates C, Morton CE, Curtis HJ, Mehrkar A, Evans D, Inglesby P, Cockburn J, McDonald HI, MacKenna B, Tomlinson L, Douglas IJ, Rentsch CT, Mathur R, Wong AYS, Grieve R, Harrison D, Forbes H, Schultze A, Croker R, Parry J, Hester F, Harper S, Perera R, Evans SJW, Smeeth L, Goldacre B. Factors associated with COVID-19-related death using OpenSAFELY. Nature. 2020 Aug;584(7821):430-436. doi: 10.1038/s41586-020-2521-4. Epub 2020 Jul 8.
- Background: PubMed 23982678Esposito K, Kastorini CM, Panagiotakos DB, Giugliano D. Mediterranean diet and metabolic syndrome: an updated systematic review. Rev Endocr Metab Disord. 2013 Sep;14(3):255-63. doi: 10.1007/s11154-013-9253-9.
- Background: PubMed 21788627InterAct Consortium; Romaguera D, Guevara M, Norat T, Langenberg C, Forouhi NG, Sharp S, Slimani N, Schulze MB, Buijsse B, Buckland G, Molina-Montes E, Sanchez MJ, Moreno-Iribas MC, Bendinelli B, Grioni S, van der Schouw YT, Arriola L, Beulens JW, Boeing H, Clavel-Chapelon F, Cottet V, Crowe FL, de Lauzon-Guillan B, Franks PW, Gonzalez C, Hallmans G, Kaaks R, Key TJ, Khaw K, Nilsson P, Overvad K, Palla L, Palli D, Panico S, Quiros JR, Rolandsson O, Romieu I, Sacerdote C, Spijkerman AM, Teucher B, Tjonneland A, Tormo MJ, Tumino R, van der AD, Feskens EJ, Riboli E, Wareham NJ. Mediterranean diet and type 2 diabetes risk in the European Prospective Investigation into Cancer and Nutrition (EPIC) study: the InterAct project. Diabetes Care. 2011 Sep;34(9):1913-8. doi: 10.2337/dc11-0891. Epub 2011 Jul 25.
- Background: PubMed 26260349Esposito K, Maiorino MI, Bellastella G, Chiodini P, Panagiotakos D, Giugliano D. A journey into a Mediterranean diet and type 2 diabetes: a systematic review with meta-analyses. BMJ Open. 2015 Aug 10;5(8):e008222. doi: 10.1136/bmjopen-2015-008222.
- Background: PubMed 28800091Echeverria G, McGee EE, Urquiaga I, Jimenez P, D'Acuna S, Villarroel L, Velasco N, Leighton F, Rigotti A. Inverse Associations between a Locally Validated Mediterranean Diet Index, Overweight/Obesity, and Metabolic Syndrome in Chilean Adults. Nutrients. 2017 Aug 11;9(8):862. doi: 10.3390/nu9080862.
- Background: PubMed 26644246Sotos-Prieto M, Bhupathiraju SN, Mattei J, Fung TT, Li Y, Pan A, Willett WC, Rimm EB, Hu FB. Changes in Diet Quality Scores and Risk of Cardiovascular Disease Among US Men and Women. Circulation. 2015 Dec 8;132(23):2212-9. doi: 10.1161/CIRCULATIONAHA.115.017158. Epub 2015 Oct 5.
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- Background: PubMed 28954418Schwingshackl L, Schwedhelm C, Galbete C, Hoffmann G. Adherence to Mediterranean Diet and Risk of Cancer: An Updated Systematic Review and Meta-Analysis. Nutrients. 2017 Sep 26;9(10):1063. doi: 10.3390/nu9101063.
- Background: PubMed 28700845Sotos-Prieto M, Bhupathiraju SN, Mattei J, Fung TT, Li Y, Pan A, Willett WC, Rimm EB, Hu FB. Association of Changes in Diet Quality with Total and Cause-Specific Mortality. N Engl J Med. 2017 Jul 13;377(2):143-153. doi: 10.1056/NEJMoa1613502.
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- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The MedLIFE app in people with Lifestyle, run by Universidad Autonoma de Madrid 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 7 inclusion and 4 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 9 Oct 2026. 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?
Changes in the Mediterranean Lifestyle Index (MedLIFE) (time frame: 6-8 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06601478, which also lists 26 linked publications.
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 9 Oct 2026.