Control of cardiovascular risk factors with tailored recommendations: a randomized controlled trial

Abstract

This study analyzed the efficacy of tailored recommendations to control cardiovascular risk factors at 1-year follow-up in a population-based randomized controlled trial in individuals aged 35-74 years with no history of cardiovascular disease at baseline. Total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol and systolic and diastolic blood pressure (BP) were measured at baseline and at 1-year follow-up. The primary outcome was the quantitative change in total cholesterol. To estimate the differences within and between groups, McNemar and Student t-tests were applied according to an intention-to-treat strategy. We enrolled 955 individuals [52.3% women; mean age, 50 years (standard deviation 10)]. Finally, 1 participant in each group presented a cardiovascular event and 768 were reexamined at 1-year follow-up. Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively]. Men in the intervention group showed significant decreases in systolic and diastolic BP [117.2 (14.6) to 115.6 mmHg (14.1) and 77.9 (9.7) to 76.5 mmHg (9.7), respectively]; no changes were found in the rates of total cholesterol <5.2 mmol/L and LDL cholesterol <3.0 mmol/L. In the control group, both values were significantly decreased (43.5 to 36.4% and 26.4 to 20.8%, respectively) in men. In the stratified analysis, women showed no differences in any of the outcomes. In conclusion, an intervention with tailored recommendations increased mean total cholesterol values. The intervention effect was higher in men who maintained blood lipids at optimal levels and had decreased BP values. This study analyzed the efficacy of tailored recommendations to control cardiovascular risk factors at 1-year follow-up in a population-based randomized controlled trial in individuals aged 35-74 years with no history of cardiovascular disease at baseline. Total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol and systolic and diastolic blood pressure (BP) were measured at baseline and at 1-year follow-up. The primary outcome was the quantitative change in total cholesterol. To estimate the differences within and between groups, McNemar and Student t-tests were applied according to an intention-to-treat strategy. We enrolled 955 individuals [52.3% women; mean age, 50 years (standard deviation 10)]. Finally, 1 participant in each group presented a cardiovascular event and 768 were reexamined at 1-year follow-up. Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively]. Men in the intervention group showed significant decreases in systolic and diastolic BP [117.2 (14.6) to 115.6 mmHg (14.1) and 77.9 (9.7) to 76.5 mmHg (9.7), respectively]; no changes were found in the rates of total cholesterol <5.2 mmol/L and LDL cholesterol <3.0 mmol/L. In the control group, both values were significantly decreased (43.5 to 36.4% and 26.4 to 20.8%, respectively) in men. In the stratified analysis, women showed no differences in any of the outcomes. In conclusion, an intervention with tailored recommendations increased mean total cholesterol values. The intervention effect was higher in men who maintained blood lipids at optimal levels and had decreased BP values.