Physicians' Academy for Cardiovascular Education

Reduced CV risk with intensive lifestyle intervention program in overweight/obese adults

Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial

Literature - Salas-Salvadó J, Diaz-López A, Ruiz-Canela M et al. - Diabetes Care 2018: published online ahead of print

Introduction and methods

Moderate weight loss through lifestyle intervention (5-10% of initial body weight) is associated with improvement of cardiometabolic abnormalities in overweight/obese individuals [1,2] and reduction in risk of T2DM [3]. However, the long-term cardiovascular impact of weight loss has never been demonstrated in randomized clinical trials (RCTs).

This sub-analysis of the parallel-group, multicenter, randomized PREvención con DIeta MEDiterránea (PREDIMED)-Plus trial assessed the 12-month effects of an intensive lifestyle intervention on weight loss, adiposity markers, and intermediate markers of CV risk, including overweight/obese (BMI ≥27 and <40 kg/m²) individuals (aged 55-75 years) with metabolic syndrome (MetS) who were randomized 1:1 to receive either the intervention (intervention group [IG]; n=327) or usual care (control group [CG]; n=299). Subjects with a history of CVD were excluded, leaving a study sample of 626 participants.

The lifestyle intervention consisted of an energy restricted Mediterranean diet (erMedDiet), physical activity (PA) promotion, and behavioral support. Questionnaires were used to assess self-reported adherence to the erMedDiet, food frequency, and physical activity.

The primary endpoint was between-group differences in weight loss at 6 and 12 months of intervention. Weight-related secondary endpoints at 6 and 12 months were the between-group differences in the proportions of participants who had either a stable weight or weight below baseline values, those who lost at least 5% or 10% of their initial weight, and those reversing obesity (changing BMI from ≥30 to <30kg/m²).

Main results

Compliance with dietary and lifestyle interventions

Intention-to-treat analysis: Weight loss and maintenance


This study showed clinically meaningful weight loss, high adherence to recommendations, and improvements in MetS components and other intermediate markers of CV risk with the intensive PREDIMED-Plus lifestyle intervention using an erMedDiet, PA promotion, and behavioral support for 12 months in overweight/obese adults with MetS, compared to standard care, after 12 months. Additionally, the interventions resulted in modest improvements in glycemic control, insulin sensitivity, and dyslipidemia in individuals with or at risk for diabetes.


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