Objective: To evaluate the additional benefit of "intensive" health care advice through six group sessions, compared with the advice usually offered to subjects with multiple risk factors for cardiovascular disease.
Design: Prospective, randomised controlled clinical study lasting 18 months.
Setting: 681 subjects aged 30-59 years, with at least two cardiovascular risk factors in addition to moderately high lipid concentrations: total cholesterol > or = 6.5 mmol/l on three occasions, triglycerides < 4.0 mmol/l, and ratio of low density lipoprotein cholesterol to high density lipoprotein cholesterol > 4.0. Most (577) of the subjects were men.
Main outcome measure: Percentage reduction in total cholesterol concentration (target 15%); quantification of the differences between the two types of health care advice (intensive v usual) for the Framingham cardiovascular risk and for individual risk factors.
Results: In the group receiving intensive health care advice total cholesterol concentration decreased by 0.15 mmol/l more (95% confidence interval 0.04 to 0.26) than in the group receiving usual advice. The overall Framingham risk dropped by 0.068 more (0.014 to 0.095) in the group receiving intensive advice, and most of the risk factors showed a greater change in a favourable direction in this group than in the group receiving usual advice, but the differences were seldom significant. The results from questionnaires completed at the group sessions showed that the subjects improved their lifestyle and diet.
Conclusion: Limited additional benefit was gained from being in the group receiving the intensive health care advice. It is difficult to make an important impact on cardiovascular risk in primary care by using only the practice staff. Better methods of communicating the messages need to be devised.