Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06601478

Development and Implementation of a Tool for the Evaluation and Monitoring of the Mediterranean Lifestyle in the Clinical Setting

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Lifestyle Cardiovascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Juan Ramón Jiménez

Huelva, Andalusia, 21005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

The MedLIFE app

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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)

  4. Changes in intermediate biomakers of CVD: glucose metabolism

    Time frame: 6-8 months

    Changes in glycated hemoglobin %

  5. Changes in anthropometric metrics: hip and waist circunference (cm)

    Time frame: 6-8 months

    Changes in:

    • Hip circunference (cm)
    • Waist circunference (cm)

  6. Changes in anthropometric metrics: BMI

    Time frame: 6-8 months

    Body mass index (BMI): measured by weight (Kg) and height (m²) combined

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Collaborators

  • Hospital Universitario Juan Ramón Jiménez

Registry information

Official study 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

Acronym: MedLIFE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.