A behavioral intervention that involves regular counseling sessions could help patients with type 2 diabetes increase their levels of physical activity and decrease their amount of sedentary time, according to findings from a prospective, randomized trial of 300 physically inactive patients with type 2 diabetes.
“The primary strength of this study is the application of an intervention targeting both physical activity and sedentary time across all settings (e.g., leisure, transportation, household, and occupation), based on theoretical grounds and using several behavior-change techniques,” wrote Stefano Balducci, MD, of Sapienza University in Rome and his colleagues. The findings were published in JAMA.
Half the participants were randomized to an intervention that involved one individual theoretical counseling session with a diabetologist and eight biweekly theoretical and practical counseling sessions with an exercise specialist each year for 3 years. The other half received standard care in the form of recommendations from their general physician about increasing physical activity and decreasing sedentary time. Both groups also received the same general treatment regimen according to guidelines.
The findings showed significant increases in volume of physical activity, light-intensity physical activity, and moderate to vigorous physical activity in the intervention group during the first 4 months of the trial. Those increases also were greater than the increases seen in the usual care group. Patients in the intervention group also showed greater decreases in sedentary time, compared with those in the control group during the same time.
After 4 months, the increases in physical activity in the intervention group plateaued but remained stable until 2 years. After that, the levels of activity declined but still remained significantly higher than at baseline. The level of sedentary time also increased after 2 years but was still lower than at baseline.
By the end of the study, the intervention group accumulated 13.8 metabolic equivalent hours/week of physical activity volume, compared with 10.5 hours in the control group; 18.9 minutes/day of moderate to vigorous intensity physical activity, compared with 12.5 minutes in the control group; and 4.6 hours/day of light-intensity physical activity, compared with 3.8 hours in the control group. In regard to sedentary time, the intervention group accumulated 10.9 hours/day, compared with 11.7 hours in the control group. All differences were statistically significant.
“The present findings support the need for interventions targeting all domains of behavior to obtain substantial lifestyle changes, not limited to moderate- to vigorous-intensity physical activity, which has little effect on sedentary time,” Dr. Balducci and his coauthors wrote. “This concept is consistent with a 2018 report showing that physical activity, sedentary time, and cardiorespiratory fitness are all important for cardiometabolic health.”
For the secondary outcomes of cardiorespiratory fitness and lower-body strength, the authors saw significant improvements in the intervention group, whereas the control group showed a worsening in those outcomes. The intervention group also showed significant improvements in fasting plasma glucose level, systolic blood pressure, total coronary heart disease 10-year risk score, and fatal coronary heart disease 10-year risk score. They also had significantly greater improvements than did the control group in total stroke risk score, hemoglobin A1c, fasting plasma glucose levels, and coronary heart disease risk.
In all, there were 41 adverse events in the intervention group, compared with 59 in the control group, outside of the sessions. During the sessions, participants in the intervention group experienced mild hypoglycemia (8 episodes), tachycardia/arrhythmia (3), and musculoskeletal injury or discomfort (19).
One of the limitations highlighted by the authors was that the benefits of their strategy could vary in other cohorts because of differences in climatic, socioeconomic, or cultural settings.
The study was supported by the Metabolic Fitness Association. Three authors declared grants and personal fees from pharmaceutical companies, and one author was an employee of Technogym. No other conflicts of interest were declared.
SOURCE: Balducci S et al. JAMA. 2019;321:880-90.