Effects of health counseling on high-risk cardiology outpatient clinical trial behavioural risk factors in a population: a randomized clinical trial

Background An evaluation study of an individual lifestyle advice intervention to reduce cardiovascular risk, behaviours (high fat consumption, smoking, physical inactivity). Methods A randomized, controlled trial at the cardiology outpatient clinic of the University Hospital Maastricht. Participants were at high risk of incurring a cardiovascular event. Changes in risk behaviours and behavioural determinants were assessed with self-administered validated questionnaires. Results Questionnaires were completed by 1270 patients at baseline, 1169 after 4 months (92%), and 1032 after 18 months (81.3%). After 4 months, intention-to-treat analyses revealed a decrease in fat consumption (- 5.6%, P= 0.000), a reduction in the percentage of smokers [odds ratio (OR) 0.57, 95% confidence intervals (Cl) 0.33-0.97] and a trend towards a maintained physical activity level (OR 1.28, 95% Cl 0.97-1.70). No long-term effects were found. Conclusion The lifestyle advice intervention was potentially effective in changing cardiovascular risk behaviours, but should be further improved to be effective in secondary cardiovascular prevention. The main limitations of the study were related to the randomization procedure and the self-selection of patients and cardiologists.