Effect of a behavioral counseling for adoption and maintenance of a physically active lifestyle on long-term mortality in people with type 2 diabetes: post hoc analysis of the Italian Diabetes and Exercise Study_2

An inverse relationship between physical activity and mortality has been observed in epidemiological surveys, but not in randomized clinical trials. This post hoc, not pre-specified analysis of the Italian Diabetes and Exercise Study_2 randomized clinical trial assesses the effect of a physical activity-based counseling intervention on long-term mortality in people with type 2 diabetes. Three hundred physically inactive and sedentary individuals are recruited in three outpatient diabetes clinics in Rome from October 2012 to February 2014. Participants are randomized 1:1 to a Control group receiving standard care and an Intervention group receiving a one-month theoretical and practical counseling targeting both PA and sedentary behavior, each year for 3 years. For this analysis, all-cause and cause-specific mortality are the primary and secondary endpoint, respectively. The vital status is verified on 30 June 2024 and all participants are analyzed. After a 10.3-year follow-up, the number of deaths is significantly lower among Intervention than Control participants (18 vs 35, p = 0.010), mainly due to fewer cancer deaths. Age-and sex-adjusted hazard ratios for mortality are significantly lower in Intervention versus Control participants (0.498 [0.282-0.879], p = 0.016) and between-group differences remain after further adjustment for treatments and baseline cardiometabolic risk profile, major complications, and physical activity and fitness level (0.414 [0.229-0.750], p = 0.004). Limitations include the post hoc type of analysis, a post-trial observational follow-up with no assessment of physical activity and fitness parameters, possible unmeasured confounders, and the non-generalizability to different populations. A behavioral counselling targeting all domains of physical activity and sedentary behavior is associated with reduced long-term mortality risk in people with type 2 diabetes. ClinicalTrials.gov Identifier: NCT01600937.