Ricerc@Sapienza

Importance: There is no definitive evidence that changes in physical activity/sedentary behavior can be maintained long term in individuals with type 2 diabetes. Objective: To investigate whether a behavioral intervention strategy can produce a sustained increase in physical activity and reduction in sedentary time among individuals with type 2 diabetes. Design, Setting, and Participants: The Italian Diabetes and Exercise Study 2 was an open-label, assessor-blinded, randomized clinical superiority trial, with recruitment from October 2012 to February 2014 and follow-up until February 2017. In 3 outpatient diabetes clinics in Rome, 300 physically inactive and sedentary patients with type 2 diabetes were randomized 1:1 (stratified by center, age, and diabetes treatment) to receive a behavioral intervention or standard care for 3 years. Interventions: All participants received usual care targeted to meet American Diabetes Association guideline recommendations. Participants in the behavioral intervention group (n = 150) received 1 individual theoretical counseling session and 8 individual biweekly theoretical and practical counseling sessions each year. Participants in the standard care group (n = 150) received only general physician recommendations. Main Outcomes and Measures: Co-primary end points were sustained change in physical activity volume, time spent in light-intensity and moderate- to vigorous-intensity physical activity, and sedentary time, measured by an accelerometer. Results: Of the 300 randomized participants (mean [SD] age, 61.6 [8.5] years; 116 women [38.7%]), 267 completed the study (133 in the behavioral intervention group and 134 in the standard care group). Median follow-up was 3.0 years. Participants in the behavioral intervention and standard care groups accumulated, respectively, 13.8 vs 10.5 metabolic equivalent-h/wk of physical activity volume (difference, 3.3 [95% CI, 2.2-4.4]; P <.001 vs="" min="" moderate-="" to="" vigorous-intensity="" physical="" activity="" ci="" p="" h="" of="" light-intensity="" and="" sedentary="" time="" significant="" between-group="" differences="" were="" maintained="" throughout="" the="" study="" but="" difference="" in="" decreased="" during="" third="" year="" from="" there="" adverse="" events="" behavioral="" intervention="" group="" standard="" care="" outside="" sessions="" participants="" experienced="" commonly="" musculoskeletal="" injury="" mild="" hypoglycemia="" conclusions="" relevance:="" among="" patients="" with="" type="" diabetes="" at="" clinics="" rome="" who="" followed="" up="" for="" years="" a="" strategy="" compared="" resulted="" sustained="" increase="" decrease="" time.="" further="" research="" is="" needed="" assess="" generalizability="" these="" findings.="" trial="" registration:="" clinicaltrials.gov="" identifier:="" nct01600937.="">