Development and Implementation of a Tool for the Evaluation and Monitorization of Mediterranean Lifestyle At Clinical Settings: MEDLIFE Index, a Proof of Concept Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Spain
Hospital Universitario Juan Ramón Jiménez
RECRUITING
Huelva
Contact Information
Primary
Mercedes Sotos Prieto, PhD
mercedes.sotos@uam.es
914 976 776
Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 80
Treatments
Experimental: Lifestyle 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 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.
No_intervention: Control, no Lifestyle 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.
Related Therapeutic Areas
Sponsors
Leads: Universidad Autonoma de Madrid
Collaborators: Hospital Universitario Juan Ramón Jiménez

This content was sourced from clinicaltrials.gov

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