Effectiveness of an intensive intervention to improve lifestyles in people with intermediate cardiovascular risk (DATE study): Study protocol for a randomized controlled trial

Abstract

[ENG]Aim: The aim of this study was to evaluate the effectiveness of an intensive intervention led by primary care nurses for lifestyle modification among people with intermediate cardiovascular risk. Background: Cardiovascular diseases may be prevented by adopting healthy lifestyles. Interventions focused on populations at risk are more efficient than those aimed at the general population. More than 50 per cent of cardiovascular events occur in people with intermediate cardiovascular risk, but only a few studies have targeted this population. Design: A randomized controlled trial approved in January 2017. Methods: We will recruit 208 participants aged 35–74 years who have intermediate cardiovascular risk. They will be selected by consecutive sampling and will be randomized into a control group or intervention group. Individual standardized brief counselling on healthy lifestyles will be provided to both groups. Additionally, individuals from the intervention group will receive four weekly group sessions focusing on cardiovascular risk, healthy diet, moderation in alcohol consumption, daily physical activity, stress management and smoking cessation and two motivational followup calls. The primary outcome will be the lifestyle modification measured by total steps recorded by a pedometer, total score on the Mediterranean Diet Adherence Screener and percentage of current smokers. Discussion: This study will allow us to investigate whether an intensive intervention based on a multifactorial group approach is more effective in lifestyle modification than individual standardized brief counseling among adults with intermediate cardiovascular risk. Our results could lead to the establishment of new strategies for cardiovascular risk management.