| The objective of the present study is to examine an extended version of a previously proven effective self-management intervention, comparing the effectiveness of additional sessions geared to helping recently diagnosed type 2 patients to strive for and achieve challenging self-management goals which meet the standards of optimal diabetes care with additional sessions which continue to emphasize small short-term goals. A prospective randomized controlled design will be employed to answer the following research questions:1) Is an extended approach emphasizing more challenging goals more effective with regard to self-management outcomes than an approach which continues to emphasize small short-term goals? Objectives: significant more improvements in all self-management measures by 12 months which are maintained at 18 months. Significant decrease in weight (at least 5%), blood pressure (at least 5 mmHG) and Hba1c by 18 months.2) Do improvements in patient s proactive coping skills, motivation, self-efficacy, and outcome satisfaction mediate the effectiveness of the interventions in changing and maintaining self-management behaviors? Objectives: Compared to the control condition, the challenging intervention will achieve significant increase in self-regulatory skills, motivation, self-efficacy and outcome satisfaction after the 12 month program, which will, in turn, be significant predictors of improvements and maintenance of self-management behaviors at 18 months.3) Is the intervention equally effective across patients with regard to socio-demographic background (e.g. age, education, gender and ethnic background), and to what extent do other relevant psychological characteristics (eg self-control and outcome expectations) moderate self-management behavior? Objective: Based on theories of self-regulation and proactive coping, this study examines the effectiveness of an intervention to achieve and maintain an optimal self-management in patients with type-2 diabetes. It builds forth on the success of a previous intervention, proven effective in helping patients recently diagnosed with type-2 diabetes to achieve and maintain small changes in self-management behaviors using a proactive 5-step plan. The present study examines an extended version of this intervention that aims to address more challenging self-management goals once patients have mastered the skills necessary to achieve relatively small improvements in their self-management. The effectiveness of this more challenging goal setting strategy will be compared with one that continues to focus on small goals which are achievable in the short term. Research questions: 1) Is an extended approach emphasizing more challenging goals more effective with regard to self-management behaviors and cardiovascular risk factors than one continuing to focus on small goals? 2) Do improvements in patient s proactive skills, motivation, self-efficacy and outcome satisfaction mediate the effectiveness of the interventions in changing and maintaining self-management behaviors? 3) Is the intervention equally effective across patients with regard to socio-demographic background (e.g. age, education, gender and ethnic background), and to what extent do other relevant psychological characteristics moderate actual self-management behavior? Study design: In a prospective randomized controlled design comparing two conditions, (2x150) recently diagnosed (< 5 years) type 2 diabetic patients will be recruited from primary care, and followed for 18 months (including 6 month follow-up). Intervention: All patients will receive the original intervention which uses a 5-step plan, based on self-regulation theory and proactive coping, to help them translate their intentions into concrete goals and plans. The original program will be extended to 12 months, comparing the effectiveness of a continued focus on small, realistic goals (control condition) with a format in which the focus shifts to more challenging goals geared to achieving an optimal diabetes management (experimental condition). Outcome measures: Primary outcome is self-management behavior (including diet, physical activity, medication adherence and smoking), corroborated by medical measures (BMI, blood pressure, Hba1c and lipid profiles). Mediators include proactive skills, motivation, self-efficacy and outcome satisfaction. Moderators include socio-demographic characteristics, self-control, the tendency to be goal oriented and diabetes distress. Time schedule: Year 1: Development and pilot of extended intervention program, patient recruitment, start of intervention, baseline data-collection; Year 2: intervention and follow-up data-collection; Year 3: follow-up data-collection, data-analyses and manuscript preparation. |
