Type 2 Diabetes Clinical Trial
Official title:
Italian Diabetes and Exercise Study 2 - A Long-term Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle
Current guidelines recommend supervised mixed (aerobic+resistance) physical activity to ensure optimal benefits to control blood glucose, lipids, blood pressure, and other cardiovascular risk and to minimize injuries. However, these guidelines are difficult to put into action for a number of barriers and poor long-term patient compliance. This project will assess the effect of a behavioral intervention strategy on the promotion and maintenance of physical activity in type 2 diabetes.
An increasing prevalence of type 2 diabetes is associated with an aging population, a
significant rise in the prevalence of obesity, and a sedentary lifestyle. In Italy,
prevalence of diabetes is approximately 6%, with 90-95% of diabetic subjects having type 2.
Strong evidence supports the importance of physical activity in the management of type 2
diabetes. However, current guidelines are difficult to put into action in this target
population because of barriers and poor patient long-term compliance so it is difficult even
identify the best strategies for physical activity behavior change. Existing studies employ
small groups and clinically-based approaches with limited theoretical grounding for
recommended health behavior change. Most fail to offer practical, sustainable, economically
viable solutions, with documented long-term intervention efficacy. This study proposes to
monitor any objective measurable changes in LTPA over a 3-year period after behavioral
interventions (Physician recommendations for daily PA with and without supervised exercise
training including individual theoretic & practical counseling). Hopefully, such behavioral
intervention would offer a feasible procedure for long-term maintenance of physical activity
and thus meet the call for a change of paradigm to move beyond the limited clinical focus by
including theoretically population-based and "real-life" approaches for the management Type
2 Diabetes.
After the selection for eligibility and a run-in period, patients will be randomized in two
groups: 1) exercise (EXE) group receiving theoretical & practical exercise counseling
including 2 sessions/ per wk for 1 month of supervised exercise training; and 2) control
(CON) group receiving standard care including general physician recommendations for daily
PA. Changes in physical activity behavior will be quantified using an accelerometer, in
addition to a daily diary.
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