Nurse health and lifestyle modification versus standard care in 40 to 70 year old regional adults : Study protocol of the Management to Optimise Diabetes and mEtabolic syndrome Risk reduction via Nurse-led intervention (MODERN) randomized controlled trial

Background
Metabolic syndrome (MetS), the clustering of multiple leading risk factors, predisposes individuals to increased risk for developing type 2 diabetes and/or cardiovascular disease (CVD). Cardio-metabolic disease risk increases with greater remoteness where specialist services are scarce. Nurse-led interventions are effective for the management of chronic disease. The aim of this clinical trial is to determine whether a nurse-implemented health and lifestyle modification program is more beneficial than standard care to reduce cardio-metabolic abnormalities and future risk of CVD and diabetes in individuals with MetS.

Methods
MODERN is a multi-centre, open, parallel group randomized controlled trial in regional Victoria, Australia. Participants were self-selected and individuals aged 40 to 70 years with MetS who had no evidence of CVD or other chronic disease were recruited. Those attending a screening visit with any 3 or more risk factors of central obesity, dyslipidemia (high triglycerides or low high density lipoprotein cholesterol) elevated blood pressure and dysglycemia were randomized to either nurse-led health and lifestyle modification (intervention) or standard care (control). The intervention included risk factor management, health education, care planning and scheduled follow-up commensurate with level of risk. The primary cardio-metabolic end-point was achievement of risk factor thresholds to eliminate MetS or minimal clinically meaningful changes for at least 3 risk factors that characterise MetS over 2 year follow-up. Pre-specified secondary endpoints to evaluate between group variations in cardio-metabolic risk, general health and lifestyle behaviours and new onset CVD and type 2 diabetes will be evaluated. Key outcomes will be measured at baseline, 12 and 24 months via questionnaires, physical examinations, pathology and other diagnostic tests. Health economic analyses will be undertaken to establish the cost-effectiveness of the intervention.

Discussion
The MODERN trial will provide evidence for the potential benefit of independent nurse-run clinics in the community and their cost-effectiveness in adults with MetS. Findings will enable more nurse-led clinics to be adopted outside of major cities and encompassing other chronic diseases as a key primary preventative initiative.

Trial registration
MODERN is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000229471) on 19 February 2016 (retrospectively registered).

Secondary identifiers: MODERN is an investigator-initiated trial funded by the National Health and Medical Research Council of Australia from 2014 to 2017 via a Project Grant (ID No. APP1069043) and was approved by the Australian Catholic University Human Research Ethics Committee (Project No: 2014 244 V) and the Department of Health Human Research Ethics Committee (Project No:38/2014) for the release of Medicare claims information.