Posted Apr 19 , 2019 09:11 AM

Effect of a Behavioral Intervention Strategy on Sustained Change in Physical Activity and Sedentary Behavior in Patients with Type 2 Diabetes: The IDES_2 Randomized Clinical Trial

Balducci S, et al. JAMA 2019 Online March 5

Institute Summary (excerpted from the Abstract):

While we know increasing physical activity is important, there is no definitive evidence that changes in physical activity/sedentary behavior can be maintained long term in individuals with type 2 diabetes. The authors 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. 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 to receive a behavioral intervention or standard care for 3 years. 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. 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 met-h/wk P < .001), 18.9 vs 12.5 min/da of moderate- to vigorous-intensity physical activity (difference, 6.4min/da P < .001), 4.6 vs 3.8 hr/da of light-intensity physical activity (difference, 0.8 hr/da P < .001), and 10.9 vs 11.7 h/d of sedentary time (difference, −0.8 hr/da P < .001). Significant between-group differences were maintained throughout the study, but the between-group difference in moderate- to vigorous-intensity physical activity decreased during the third year from 6.5 to 3.6 min/d. There were 41 adverse events in the behavioral intervention group and 59 in the standard care group outside of the sessions; participants in the behavioral intervention group experienced 30 adverse events during the sessions (most commonly musculoskeletal injury/discomfort and mild hypoglycemia).

Why is this important?

This study combines both a counseling strategy geared toward behavior change which has been validated in a separate study (Di Loreto C, et al. Diabetes Care 2003;26:404–408) and an exercise expert to both counsel patients on how to be less sedentary and engage them in both aerobic and resistance exercise twice weekly for approximately 1 hour, a strategy that has also been validated in a previous publication (Balducci S, et al. Diabetes Care 2017;40:1444–1452). This strategy of 8 weeks of patient engagement each year resulted in patients becoming more active, and the repeat of the strategy for 3 years is what makes this publication so important! Also, it is worth noting that sedentary individuals who begin exercise programs may develop some adverse events (usually musculoskeletal) and may also develop mild hypoglycemia depending on their regimen.

Read the Abstract: