Background: It is uncertain whether health counselling after community-based health checkups for high-risk individuals of lifestyle-related disease enhances their referral to physicians. Methods: We performed a clustered randomized controlled trial of untreated high-risk individuals aged 40 to 74 years who were screened from the annual health checkup in 2014 and 2015 under the national health insurance in 43 municipalities around Japan, assigning 21 intervention and 22 usual care municipalities. The high-risk conditions were severe forms of hypertension, diabetes, dyslipidemia (for men), and proteinuria. For the intervention group, the theory-based health counselling was performed to enhance referrals to physicians, while each municipality performed its own standard counselling for the usual care group. Data on clinical visits and risk factors were collected systematically and anonymously from the databases of health insurance qualification, health insurance claims, and annual health checkups. Hypotheses are that the cumulative proportion of seeing physicians (clinical visits) is higher in the intervention than the usual care groups, and that those in the intervention group have lower cumulative incidence of composite outcomes associated with lifestyle-related diseases. Results: The numbers of subjects for the analyses were 8,977 in the intervention group and 6,733 in the usual care group. Among them, 6,758 had hypertension, 2,147 had diabetes, 2,861 had dyslipidemia, and 1,221 had proteinuria in the intervention group, with corresponding numbers of 4,833, 1,517, 2,262, and 845, respectively, in the usual care group. There were no material differences in mean levels and proportions of major cardiovascular risk factors between the two groups. Conclusions: We expect to provide scientific evidence on the effectiveness of health counselling.

There is limited evidence examining the association between B vitamin supplementation and improved endothelial function via lowering plasma homocysteine levels. This study investigated whether low dose B vitamin supplementation improves endo thelial dysfunction in Japanese adults with one or more compo nents of metabolic syndrome. A randomized, controlled, crossover trial, without a washout period or blinding of subjects, was conducted from May September, 2010. The subjects were 127 Japanese men and women aged 40-65 years who had at least one component of metabolic syndrome without medication. Participants took a supplement drink for two months but were divided into early intervention or later intervention groups. The flow mediated dilatation, plasma homocysteine level, serum B vitamins, and vitamin C levels were measured. A significant increase in serum B vitamins and vitamin C levels, and a reduction in plasma homocysteine levels were observed. The mean serum homocysteine level pre and post intervention was 9.8 and 8.2 µmol/L in the early intervention group and 10.8 and 7.4 µmol/L in the later intervention group (p<0.01). However, no significant changes in flow mediated dilatation was found. Low dose multi vitamin supplementation including B vitamins is associated with a significant reduction in plasma homocysteine levels among patients with one or more components of metabolic syndrome. This study was registered at the University Hospital Medical Information Network (UMIN) centre, and has the identifier UMIN000004436.

Early diagnosis and treatment are necessary to prevent lifestyle-related diseases among high-risk individuals. This study aimed to examine the impact of counselor characteristics on clinic visits among individuals at high risk for lifestyle-related diseases. A total of 8975 patients aged 40 to 74 years with lifestyle-related comorbidities, who underwent an annual health checkup and received health counseling, were included in this study. Data intervention timing, mode of counseling, number of counseling sessions, and explanation methods were collected. We assessed the impact of counselor characteristics, including profession (public health nurse, clinical nurse, and nutritionist), age, and years of counseling experience, on counseling outcomes. The probability ratios (95% confidence intervals) of clinic visits were 1.22 (1.11–1.35) for public health nurses and 1.04 (0.90–1.20) for nurses compared with nutritionists. After adjustment for participant and counselor characteristics and initial timing, mode, and number of counseling sessions, the corresponding probability ratios (95% confidence intervals) were 1.16 (1.05–1.29) and 1.12 (0.95–1.31), respectively. Counselor age and years of experience did not influence clinic visits of the target population. Public health nurses were more effective in increasing clinic visits among the target population owing to their profession-specific knowledge, skills, and experience.