Promoting Physical Activity and Reducing Sedentary Behavior in Adults with Type 2 Diabetes: Study Protocol of the DIA/01 Randomized Trial

Background: Sedentary behavior is a major modifiable risk factor for chronic metabolic disorders, particularly type 2 diabetes mellitus (T2DM). Despite recommendations promoting regular physical activity (PA), adherence remains low. DIA/01 is a multidisciplinary study designed to promote healthy lifestyles for the prevention and management of T2DM, supporting healthcare systems. Methods: A total of 123 adults with T2DM diagnosed will be enrolled at the Diabetes Center of the University Hospital of Perugia throughout 2025. Inclusion criteria are age 25–80 years, ability to walk independently, being inactive, and BMI 18.5–40 kg/m2. Exclusion criteria include severe cardiovascular, central nervous system, or musculoskeletal diseases contraindicating PA. Participants will be randomized into three groups: (1) standard care (SC); (2) SC plus theoretical PA counseling (TCPA); and (3) SC plus TCPA plus a 3-month supervised mixed exercise program. The assessment, conducted at baseline and at 6 and 12 months, includes total weekly PA (WPA) time, using IPAQ-SF and actigraphy. Moreover, glycated hemoglobin, sedentary time (ST), functional capacity, body composition, cardiometabolic risk factors, dietary adherence, perceived barriers and willingness to initiate PA, readiness to change, health-related quality of life, and sleep quality will be studied. This study is registered in the Clinical Trials Registry on 13 May 2026, with the identifier NCT07583355. Conclusions: Participants in groups (2) and (3) are expected to show greater improvements in WPA, reductions in ST, and favorable changes in metabolic and functional outcomes compared with SC. This approach may support long-term engagement in regular PA and contribute to improving the clinical management of T2DM.