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

NCT06601478 | Active Not Recruiting

• 1 other identifier: CNS2022-135623
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Lifestyle

Keywords

Lifestyle behaviours; Cardiovascular disease; Cardiovascular event; Intervention; Health App; Prevention; Mediterranean Diet

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  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)

  6-8 months

• Changes in intermediate biomakers of CVD: glucose metabolism

  Changes in glycated hemoglobin %

  6-8 months

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

  Changes in: * Hip circunference (cm) * Waist circunference (cm)

  6-8 months

• Changes in anthropometric metrics: BMI

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

  6-8 months

Study Arms (2)

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.

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.

Interventions

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.

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead
• Hospital Universitario Juan Ramón Jiménez: collaborator

Study Sites (1)

Hospital Universitario Juan Ramón Jiménez

Huelva, Andalusia, 21005, Spain

Location

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MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)