Proyecto Predimed-Plus

Predimed-Plus es un ensayo multicéntrico, aleatorizado, de prevención primaria cardiovascular en hombres (55-75 años) y mujeres (60-75), con un índice de masa corporal ≥ 27 y <40 kg/m2 y síndrome metabólico.

Los participantes se aletorizarán en dos grupos

Grupo control: consiste en una intervención similar a la realizada en el estudio Predimed-1, con dieta mediterránea suplementada con aceite de oliva virgen extra y frutos secos, sin restricción calórica ni promoción de actividad física ni objetivos de pérdida de peso.

Grupo de intervención: consiste en una intervención intensiva basada en el consumo de una dieta mediterránea hipocalórica (con una restricción calórica del 30%) suplementada con aceite de oliva virgen extra y frutos secos, además de un programa intensivo de estilo de vida con promoción de actividad física (45 minutos de caminar al día o equivalente) y objetivos de pérdida de peso que incluyen terapia conductural.

6.874 participantes han sido reclutados en 23 centros y hospitales junto con 7 grupos de apoyo de toda España.

“Vídeo PREDIMED-Plus”

“Nuevo Vídeo PREDIMED-Plus”

Resultados estarán disponibles en 2020

El objetivo primario final (primary end-point) es una combinación de eventos clínicos cardiovasculares mayores (infarto, ictus o muerte cardiovascular).

El tamaño de muestra final es de 6.874 participantes. El reclutamiento de los participantes se inició en septiembre de 2013 y finalizó en Diciembre de 2016. Los resultados finales estarán disponibles a partir de 2020.

Con el estudio Predimed-1 se demostró una reducción del 30% en el riesgo de infarto, embolia o mortalidad por enfermedad cardiovascular. Ahora, sumando la promoción de actividad física y los objetivos de pérdida de peso, es de esperar que esta reducción del riego incremente.

 

Predimed-Plus Study Data and Collaboration

We welcome proposals for collaborative research by bona fide researchers.

The Predimed-Plus collection of data and biological samples constitutes an outstanding resource for biomedical research on diet, obesity, weight-loss, cardiovascular and related chronic diseases The Predimed-plus trial is publicly-funded, and its rich data collections represent several years of work by participants, funders and researchers. This means that as well as using the data ourselves, we are open to work with researchers within the scope of our study protocol to maximise its potential. In doing so, protecting confidentiality is our highest priority, and we aim always to maintain the reputation of the study, its funders and participants. The data and biological samples can be available for investigators who seek to answer important questions on health and disease in the context of research projects that are consistent with the legal and ethical standard practices of the Predimed Plus Study and the Predimed Plus recruitment Centres. Further details on procedures and principles for accessing Predimed Plus resources are available below.

Information resources: 

– Trial information:

Data for 6,874 participants, including individual information on important risk factors and health. These data are derived from the PREDIMED-Plus trial, a 6-year parallel-group, multicenter, randomized clinical trial, involving participants from 23 Spanish recruiting centers. The main objective of the PREDIMED-PLUS trial is to evaluate the effect of an intensive weight loss intervention based on an energy-restricted traditional Mediterranean diet (MedDiet), physical activity promotion and behavioral support (intervention group, IG) on cardiovascular disease (CVD), as compared to a usual care intervention consisted only on energy-unrestricted MedDiet recommendations (control group, CG). The primary endpoints of the trial are a composite of CVD events (CVD death, nonfatal myocardial infarction, and nonfatal stroke), and long-term weight loss maintenance. Other secondary outcomes comprise: acute coronary syndromes with or without coronary revascularization, heart failure, atrial fibrillation, peripheral artery disease, venous thrombosis, type-2 diabetes mellitus and its complications, overall incidence of cancer, specific cancers in main cancer sites (breast, colorectal, prostate, lung and stomach), osteoporotic fractures, gallstone disease, symptomatic gout, neurodegenerative disorders (dementia and Parkinson’s disease), unipolar depression and eating behavior disorders. We will also address the effect of the intervention on the following intermediate outcomes: nutrient intake and overall dietary pattern, systolic and diastolic blood pressure, serum lipid concentrations, fasting glucose, glycated hemoglobin and uric acid, kidney function, liver function, C-reactive protein, anti-hypertensive, anti-diabetic and lipid-lowering medication needs, ECG traits, cognitive function, quality of life, and psychopathological scales. Recruitment began in September 2013 and ended in December 2016. The intervention will last at least 6 years and the median follow-up time for the clinical endpoints is expected to be 8 years. The protocol with a more detailed description of the PREDIMED-Plus trial is available at http://predimedplus.com/. This study was registered at the International Standard Randomized Controlled Trial (ISRCT; http://www.isrctn.com/ISRCTN89898870) with number 89898870.

– Baseline and yearly available data:

  • Information on medical history, family history and use of medication.
  • Anthropometric measurements. Weight, height and waist circumference.
  • Food frequency questionnaire.
  • Adherence to the Mediterranean diet with a 17-item questionnaire.
  • Physical activity measurements (Minnesota leisure time physical activity questionnaire, PAR-Q (Physical Activity Readiness Questionnaire), the RAPA (RAPA1 and RAPA2) (Rapid Assessment of Physical Activity), and the NHS (Nurses’ Health Study) sedentary lifestyle questionnaire. Accelerometry in a subset of participants.
  • Blood pressure and electrocardiogram.
  • Six cognitive neuropsychological tests (every 2 years): 1) MMSE; 2) Semantic verbal fluency test: “animals in 1 minute”; 3) Phonemic verbal fluency test: “words in 1 minute starting with the letter ‘p’; 4) Verbal and visual working memory: reverse digits test (WAIS-III); 5) Trail Making Test; 6) Clock test (Clock drawing test or CDT).
  • The SF-36 (36-item) quality of life questionnaire (baseline and years 1, 3, 5 and 7).
  • Three Psychopathological questionnaires: 1) Beck Depression Inventory (BDI-II); 2) Multidimensional scale of weight locus control; 3) Screening for comorbid eating disorders with diagnostic criteria (DSM-IV-TR; APA, 2000).

– Available samples at baseline, 1, 3, 5 and 7 of follow-up: Plasma, serum, morning spot urine, DNA, nails and some measured conventional biochemical parameters and biomarkers.

Consent and confidentiality:

Information is received in confidence, and we have promised study participants that their information and biological samples will be treated with absolute confidentiality and will be used only for medical research. Details of our study consent forms can be viewed here.

Our data sharing model:

Data collaboration for PREDIMED-Plus study is guided by the Data Sharing and Management guide. We follow a controlled data collaboration model, using anonymised (de-identified) study data only, for collaborating with approved researchers.
Requests are considered by the PREDIMED-Plus Steering Committee composed by Salas-Salvadó J (Chair), Martínez-González MA, Fitó M. Ros E, Tinahones F, Corella D and Estruch R (predimed_plus_scommittee@googlegroups.com). Decisions on data access are based on the scientific legitimacy of the requester and of their institution, and on assurances on information security and governance; and with regard to the study’s scientific reputation, the needs of funded study team research, the terms of participant consent, and regulatory requirements. All research using PREDIMED-Plus must be within the scope of the ethically approved PREDIMED-Plus Protocol. Studies where data and/or biological samples are requested are subject to ethics approval by the institutional review boards of the corresponding Predimed Plus recruitment centers.

Applying to conduct collaborative research on the data:

Requests for collaborations using PREDIMED-PLUS data should be made by email to the Steering Committee (predimed_plus_scommittee@googlegroups.com), using the following the PREDIMED-PLUS Preliminary Enquiry Forms:

Appendix 1: Commitment document for principal Investigators (PIs) from recruiting nodes for the PREDIMED PLUS study for access to the general project data file.
Appendix 2: Commitment document for PIs from the PREDIMED PLUS study for access to the other data files from the PREDIMED study
Appendix 3: Request form for collaboration of external researchers with the PREDIMED PLUS study to gain access to data generated during the PREDIMED PLUS study.
Appendix 4: Guide for External Researchers Requesting Data Sharing Collaboration with the PREDIMED PLUS Study.
Appendix 5: Request form for collaboration of external researchers with the PREDIMED PLUS study to gain access to samples generated during the PREDIMED PLUS study.
Appendix 6: Guide for External Researchers Requesting Sample Sharing Collaboration with the PREDIMED PLUS Study.
Appendix 7: Request form for collaboration of external researchers with the PREDIMED PLUS study to gain access to data and samples generated during the PREDIMED PLUS study.
Appendix 8: Guide for External Researchers Requesting Data and Sample Sharing Collaboration with the PREDIMED PLUS Study.
Appendix 9: Formal collaboration agreement between an external researcher requesting the use of samples and/or data and researchers from the PREDIMED PLUS study.
Appendix 10: Cost guidelines for collaborations established with external researchers requesting data and samples.

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