Nurse-led motivational interviewing to change the lifestyle of patients with type 2 diabetes (MILD-project): protocol for a cluster, randomized, controlled trial on implementing lifestyle recommendations

BACKGROUND: The diabetes of many patients is managed in general practice; healthcare providers aim to promote healthful behaviors, such as healthful diet, adequate physical activity, and smoking cessation. These measures may decrease insulin resistance, improve glycemic control, lipid abnormalities, and hypertension. They may also prevent cardiovascular disease and complications of diabetes. However, professionals do not adhere optimally to guidelines for lifestyle counseling. Motivational interviewing to change the lifestyle of patients with type 2 diabetes is intended to improve diabetes care in accordance with the national guidelines for lifestyle counseling. Primary care nurses will be trained in motivational interviewing embedded in structured care in general practice. The aim of this paper is to describe the design and methods of a study evaluating the effects of the nurses' training on patient outcomes. METHODS/DESIGN: A cluster, randomized, controlled trial involving 70 general practices (35 practices in the intervention arm and 35 in the control arm) starting in March 2007. A total of 700 patients with type 2 diabetes will be recruited. The patients in the intervention arm will receive care from the primary care nurse, who will receive training in an implementation strategy with motivational interviewing as the core component. Other components of this strategy will be adaptation of the diabetes protocol to local circumstances, introduction of a social map for lifestyle support, and educational and supportive tools for sustaining motivational interviewing. The control arm will be encouraged to maintain usual care. The effect measures will be the care process, metabolic parameters (glycosylated hemoglobin, blood pressure and lipids), lifestyle (diet, physical activity, smoking, and alcohol), health-related quality of life, and patients' willingness to change behaviors. The measurements will take place at baseline and after 14 months. DISCUSSION: Applying motivational interviewing for patients with diabetes in primary care has been studied, but to our knowledge, no other study has yet evaluated the implementation and sustainability of motivating and involving patients in day-to-day diabetes care in general practice. If this intervention proves to be effective and cost-effective, large-scale implementation of this nurse-oriented intervention will be considered and anticipated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN68707773.