Behavioral interventions helped people with type 2 diabetes be significantly more active and less sedentary, versus usual care, Italian researchers reported.
According to the 3-year IDES_2 clinical trial, adults with type 2 diabetes who participated in a counseling-based behavioral intervention averaged 13.8 metabolic equivalent-hours per week of physical activity volume versus only 10.5 hours for those receiving standard care (difference 3.3, 95% CI 2.2-4.4, P<0.001), reported Giuseppe Pugliese, MD, PhD, of La Sapienza University in Rome, and colleagues in JAMA.
People who participated in this behavioral intervention, which consisted of theoretical and practical counseling regularly for 3 years, also reported a significantly greater amount of moderate-to-vigorous- and light-intensity physical activity:
- Moderate-to-vigorous: 18.9 min/day for intervention versus 12.5 min/day for standard care
- Light: 4.6 h/day versus 3.8 h/day
Those who only received standard care in the form of general physician recommendations also reported significantly greater amounts of sedentary time each day compared with the intervention group (10.9 vs 11.7 h/d of sedentary time).
“We were quite confident that a behavioral intervention strategy could be successful in promoting physical activity and combating sedentary habits in physically inactive and sedentary people with type 2 diabetes, provided that the intervention targeted both physical activity and sedentary behavior, and that it was repeated every year,” Pugliese told MedPage Today.
The multicenter IDES_2 (Italian Diabetes and Exercise Study 2) consisted of 300 overweight and obese adults with type 2 diabetes for at least 1 year prior to the study. All participants were considered physical inactive in that they did not not reach the American Diabetes Association’s recommended amount of physical activity, and spent over 8 waking hours sitting.
Half of participants were randomized to the behavioral intervention, which included one theoretical counseling session led by a diabetologist, followed by eight biweekly individual theoretical and practical counseling sessions led by an exercise specialist each year throughout the 3-year follow-up period. Physical activity and sedentary activity were measured with an accelerometer (MyWellness Key, Technogym).
“Unfortunately, there is no definitive evidence that such a behavior change can be maintained in the long term,” added Pugliese, explaining how the trial was specifically designed to determine whether a behavioral intervention strategy that targeted both physical inactivity plus sedentary habits was effective for maintaining a more physically active lifestyle long-term.
As for secondary endpoints in the trial, the intervention group saw significant gains in cardiorespiratory fitness and lower body strength, while the standard care group saw declines in these measures.
The mean differences over time between participants in the intervention and standard care groups for secondary endpoints were (P<0.001 for all):
- Cardiorespiratory fitness: 2.63 mL/min/kg (95% CI 1.09-4.17)
- Lower body strength: 24.2 Newton-meters, a.k.a joules (95% CI 10.78-37.58)
- Flexibility: −3.9 cm (95% CI −6.40 to −1.45)
“We were surprised that, even if the increase in physical activity was more of light intensity than of moderate-to-vigorous intensity, it was associated with relevant health benefits,” Pugliese said in reference to the secondary outcomes. “In particular, there was a sustained improvement in cardiorespiratory and muscular fitness — the capacity of performing aerobic and strength exercise, respectively — which are both independently related to increased survival.”
He added how the findings are particularly relevant because it’s typically believed that only moderate-to-vigorous-intensity physical activity are capable of improving these particular fitness parameters.
More adverse events were reported among standard care patients too, with more cases of medical events like cancer, depression, and severe hypoglycemia, as well as more deaths from cancer or cardiovascular disease.
“Importantly, if sustained, even non-dramatic improvements in behavior may translate into meaningful clinical advantage,” Pugliese stressed, but added the caveat that “delivering of counseling intervention requires specifically trained personnel.”
A study limitation was that the effects of intervention strategy may be different in other cities because of climatic, socioeconomic, and cultural differences, the authors noted.
The study was supported by the Metabolic Fitness Association in Rome.
Pugliese disclosed relevant relationships with AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dohme, Mylan, Sigma-Tau, and Takeda. Co-authors disclosed multiple relevant relationships with industry including AstraZeneca, Eli Lilly, Novo Nordisk, and Takeda.