Clinical trial NCT06601478: Development and Implementation of a Tool for the Evaluation and Monitoring of the Mediterranean Lifestyle in the Clinical Setting
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lifestyle
Keywords: Lifestyle behaviours
Cardiovascular disease
Cardiovascular event
Intervention
Health App
Prevention
Mediterranean Diet
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Juan Ramón Jiménez
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the Mediterranean Lifestyle Index (MedLIFE)
timeFrame: 6-8 months
measure: Changes in intermediate lipid biomarkers of CVD
timeFrame: 6-8 months
measure: Changes in intermediate biomarkers of CVD: blood pressure
timeFrame: 6-8 months
measure: Changes in intermediate biomakers of CVD: glucose metabolism
timeFrame: 6-8 months
measure: Changes in anthropometric metrics: hip and waist circunference (cm)
timeFrame: 6-8 months
measure: Changes in anthropometric metrics: BMI
timeFrame: 6-8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
state: Andalucía
Study officials:
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