Cardiovascular effect of an intensive weight-loss lifestyle intervention based on an energy-restricted traditional Mediterranean diet (Mediet) together promotion of physical activity and behavioral support in comparison with a less intensive program using Mediet, but without energy restriction or other lifestyle changes: a randomized field trial
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,874
研究概览
简要总结
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30424822 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31005965 taste perception and genomics results (added 23/04/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31613346 results (added 16/10/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30287240 results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31868210 results (added 24/12/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31870449 results (added 31/12/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30389673 results (added 22/01/2020) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32063406 results (added 19/02/2020) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32075623 results (added 24/02/2020) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32103064 baseline cross-sectional analysis results (added 28/02/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33296471/ results (added 10/12/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33300039/ results (added 11/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33402165/ results (added 12/01/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33610419/ results (added 22/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33933749/ diet adherence and cardiometabolic risk factors results (added 05/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34020445/ gut microbiome analysis results (added 24/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34114008/ Data-Driven Clustering results (added 14/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34139471/ two-year follow up results (added 18/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34364236/ Validity of the energy-restricted Mediterranean Diet Adherence Screener (added 09/08/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34582548/ substudy results (added 29/09/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33556935/ (added 05/11/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34777250/ (added 16/11/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34846603/ longitudinal analysis (added 01/12/2021) Results article in https://pubmed.ncbi.nlm.nih.gov/35417452/ Association between cardiovascular risk factors and depression in participants with metabolic syndrome (added 14/04/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35846291/ Role of NAFLD on the Health Related QoL Response to Lifestyle in Patients With Metabolic Syndrome (added 19/07/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35941632/ Impulsivity is longitudinally associated with healthy and unhealthy dietary patterns in individuals with overweight or obesity and metabolic syndrome within the framework of the PREDIMED-Plus trial (added 09/08/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36084360/ Association of dietary carbohydrate quality with visceral fat deposition and other adiposity indicators (added 12/09/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36712515/ Impact of COVID-19 pandemic on the trial (added 31/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36870243/ Increase from low to moderate, but not high, caffeinated coffee consumption is associated with favorable changes in body fat (added 06/03/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36882739/ Prospective cohort analysis of water intake and hydration status (added 08/03/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37236477/ Environmental sustainability (added 30/05/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37443076/ Metabolic syndrome criteria and severity and carbon dioxide (CO2) emissions (added 17/07/2023) 2023 Results article in https://doi.org/10.1016/j.clnu.2023.06.030 Effect of a 3-year lifestyle intervention on telomere length in participants from PREDIMED-Plus: A randomized trial (added 24/07/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37559740/ Association of monetary diet cost of foods and diet quality in Spanish older adults (added 11/08/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37833678/ Association of adiposity with COVID-19 risk in older adults with overweight/obesity and metabolic syndrome (added 16/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37852024/ (added 19/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37851444/ (added 19/10/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38062915/ Mediterranean diet linked to microbial phenolic metabolites associated with better cognitive performance in an older population (added 18/12/2023) 2024 Results article in https://doi.org/10.1016/j.ajcnut.2024.02.021 Effect of 1-year lifestyle intervention with energy-reduced Mediterranean diet and physical activity promotion on the gut metabolome and microbiota: a randomized clinical trial (added 04/03/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38474858/ Beverage consumption and environmental sustainability (added 13/03/2024) 2024 Results article in https://doi.org/10.1161/jaha.123.031915 Associations of Alcohol Consumption With Left Atrial Morphology and Function in a Population at High Cardiovascular Risk (added 28/03/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38862960/ sex, APOE genotype, endocannabinoids and cognitive change (added 25/06/2024) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39137622/ Long-term association between water intake and kidney function in a population at high cardiovascular risk (added 14/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participants are community-dwelling high-risk people.
- •2. Men aged 55 to 75 years and women aged 60 to 75 years
- •3. Body mass index (BMI) between = 27 y < 40 kg/m2
- •4. No cardiovascular disease (CVD) at enrolment
- •5. Who fulfil at least 3 of the criteria for the metabolic syndrome (Alberti et al., 2009). Diabetic participants will represent not more than 25% of the final sample.
排除标准
- •Current exclusion criteria as of 04/06/2018:
- •1. Illiteracy or inability/unwillingness to give written informed consent or communicate with study staff
- •2. Institutionalization (the participant is a permanent or long-stay resident in a nursing home)
- •3. Documented history of previous CVD, including angina; myocardial infarction; coronary revascularization procedures; stroke (either ischemic or haemorrhagic, including transient ischemic attacks); symptomatic peripheral artery disease; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (new york heart association class II or IV); hypertrophic cardiomyopathy; or history of aortic aneurysm
- •4. Active malignant cancer or history of malignancy within the last 5 years (with exception of non-melanoma skin cancer)
- •5. Impossibility to follow the recommended diet (for religious reasons, swallowing disorders, or other reasons) or to perform physical activity
- •6. A low predicted likelihood to change dietary habits according to the Prochaska and Diclemente stages of change model (Nigg et al., 1999)
- •7. Inability to follow the scheduled intervention visits (institutionalized individuals, lack of autonomy, unable to walk, lack of a stable address, travel plans, or other reason that render the subject unable to attend scheduled visits)
- •8. Body weight loss > 5 kg during the 6 months prior to the screening visit
- •9. Intention to undergo bariatric surgery in the next 6 months
- •10. History of very low-caloric diet during the 6 months prior to the screening visit
- •11. Prior bariatric surgery or indication and willingness to receive a surgical procedure for weight loss in the near future
- •12. History of inflammatory bowel disease or small bowel resection
- •13. Obesity of known endocrine origin (with the exception of treated hypothyroidism)
- •14. Food allergy to any Mediet component
- •15. Immunodeficiency or HIV-positive status
- •16. Liver cirrhosis or chronic renal failure
- •17. Serious psychiatric disorders: schizophrenia, bipolar disease, eating disorders, depression with hospitalization in past 6 months
- •18. Any severe co-morbid condition with less than 24-month life expectancy
- •19. Alcohol abuse or addition (total daily alcohol intake >50 g) or drug abuse within the past 6 months
- •20. History of major organ transplantation
- •21. Concurrent therapy with immunosuppressive drugs or cytotoxic agents
- •22. Current treatment with systemic corticosteroids
- •23. Current use of weight loss medication
- •24. Concurrent participation in another randomised clinical trial
- •25. Patients with an acute infection or inflammation (i.e., pneumonia) are allowed to participate in the study 3 months after resolution of their condition
- •26. Any other condition that may interfere with the completion of the study protocol
- •Previous exclusion criteria:
- •1. Unable or unwilling to give written informed consent or communicate with study staff
- •2. Documented history of previous CVD, including angina; myocardial infarction; coronary revascularization procedures; stroke (either ischemic or haemorrhagic, including transient ischemic attacks); symptomatic peripheral artery disease; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure (new york heart association class II or IV); hypertrophic cardiomyopathy; or history of aortic aneurysm
- •3. Active malignant cancer or history of malignancy within the last 5 years (with exception of non-melanoma skin cancer)
- •4. Impossibility to follow the recommended diet (for religi