Development and Implementation of a Tool for the Evaluation and Monitorization of Mediterranean Lifestyle at Clinical Settings: MEDLIFE Index, a Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in the Mediterranean Lifestyle Index (MedLIFE)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: The MedLIFE app (Behavioral)
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.
结局指标
主要结局
Changes in the Mediterranean Lifestyle Index (MedLIFE)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 6-8 months
Changes in glycated hemoglobin %
Changes in anthropometric metrics: hip and waist circunference (cm)
时间窗: 6-8 months
Changes in: * Hip circunference (cm) * Waist circunference (cm)
Changes in anthropometric metrics: BMI
时间窗: 6-8 months
Body mass index (BMI): measured by weight (Kg) and height (m²) combined
次要结局
未报告次要终点
研究者
Mercedes Sotos Prieto
Principal Investigator
Universidad Autonoma de Madrid