Nurse co-ordinated health and lifestyle modification for reducing multiple cardio-metabolic risk factors in regional adults: outcomes from the MODERN randomized controlled trial

BACKGROUND : Nurse-led health and lifestyle modification programmes can prevent cardio-metabolic diseases and be advantageous where health disparities exist. AIMS : To assess the effectiveness of a nurse-driven health and lifestyle modification programme in improving cardio-metabolic risk parameters for higher-risk regional residing adults. METHODS : We conducted an open, parallel-group randomized controlled trial in two sites. Participants were aged 40-70 years with no prior cardiovascular disease who had any three or more of; central obesity, elevated triglycerides, reduced high-density lipoprotein cholesterol, elevated blood pressure (BP) and dysglycaemia. Intervention participants received individual face-to-face and telephone coaching for improving cardio-metabolic risk. Control group participants received standard care and general information about risk factor management. The primary endpoint was the percentage of participants who achieved the target risk factor thresholds or clinically significant minimum changes for any three or more cardio-metabolic risk factors during 24 months of follow-up. RESULTS : Participant average age was 57.6 (SD 7.6) years, 61% were female and 71% were employed. The primary endpoint was achieved by 76% intervention (97 of 127) and 71% usual care (92 of 129) participants [adjusted risk ratio (RR): 1.08; 95% CI 0.94, 1.24; P = 0.298]. Improved BP in the intervention group was more likely than in the control group (84% vs. 65%) (adj. RR: 1.28; 95% CI 1.11, 1.48; P = 0.001) but no other cardio-metabolic component. CONCLUSION : Nurse intervention to modify cardio-metabolic risk parameters had no enhanced effectiveness compared with usual care. However, participation was associated with improvements in cardio-metabolic abnormalities, with particular emphasis on BP. TRIAL REGISTRATION: Registered with the Australian New Zealand Clinical Trial Registry (ACTRN12616000229471).