Italian Diabetes and Exercise Study 2
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Theoretical & practical exercise counseling
Intervention type(s): Behavioral
Intervention description(s): 2 sessions/ per wk for 1 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus; diabetes education; behavioral therapy; behavior modification; physical activity; supervised exercise; physical fitness; HbA1c; modifiable cardiovascular risk factors; quality of life