Evaluation of a community intervention program in Japan using Framingham risk score and estimated 10-year coronary heart disease risk as outcome variables: a non-randomized controlled trial

BACKGROUND: Community-based programs are being widely adopted in the struggle to prevent cardiovascular diseases. No study has been conducted in Japan to evaluate the effects of a community-based health promotion program by using the Framingham risk score and 10-year CHD risk as outcome variables. The aim of the present study was to assess the effects of a program involving 6-month intervention and 18-month follow-up using such outcomes. METHODS: Participants (n = 1,983, 39.5% women, mean age 63.4 years) were selected for the study in 2008. Of these 1,983, 347 (42.4% women) subjects received the 6-month intervention. The intervention included individual counseling and group sessions, among others. After 18 months, 1,278 participants (intervention group: 238, control group: 1,040) were followed up. Changes in the Framingham risk score and 10-year coronary heart disease (CHD) risk were evaluated. ANCOVA and multiple logistic models adjusted for baseline value, age, sex and intervention times were used. RESULTS: The results showed that the differences in the Framingham risk score and mean 10-year CHD risk were significant in the intervention group compared with the control group after 6-month follow-up (-0.46 and -1.12, respectively) and were also significant after 18-month follow-up (-0.39 and -0.85, respectively). The proportion of those with intermediate 10-year CHD risk (> = 10%) was significantly lower at 6 months (OR 0.30, 95% CI 0.12-0.74) and at 18 months (OR 0.41, 95% CI 0.19-0.92). CONCLUSIONS: The six-month intervention program effectively decreased estimated 10-year CHD risk and the effects were still present at 18-month follow-up. TRIAL REGISTRATION: UMIN-CTR: UMIN000008163