The Italian Diabetes and Exercise Study (IDES): design and methods for a prospective Italian multicentre trial of intensive lifestyle intervention in people with type 2 diabetes and the metabolic syndrome.

BACKGROUND AND AIMS: The IDES is a prospective Italian multicentre randomized controlled trial to evaluate the efficacy of an intensive lifestyle intervention on modifiable cardiovascular disease (CVD) risk factors in a large cohort of people with type 2 diabetes and the metabolic syndrome. METHODS AND RESULTS: We recruited 606 subjects with type 2 diabetes and waist circumference >94 cm (M) and >80 cm (F), plus >1 other metabolic syndrome trait (IDF criteria) for both sexes, aged 40-75 years, BMI 27-40 kg/m(2), diabetes duration >1 year with a sedentary lifestyle of >6 months. Patients were randomized into two groups: a control group, receiving conventional care including exercise counselling and an intervention group, treated with a mixed (aerobic and resistance) exercise programme (150 min/week) prescribed and supervised for 12 months. Primary outcome is HbA1c reduction. Secondary outcomes include other traditional and non-traditional risk factors and their relationship to exercise volume/intensity and fitness; dosage of glucose, lipid and blood pressure-lowering drugs; global CVD 10-year risk; patient well-being; and costs. CONCLUSION: This trial verifies whether a prescribed and supervised exercise programme, including both aerobic and resistance training, is more effective than conventional exercise counselling in reducing modifiable CVD risk factors in type 2 diabetic subjects with the metabolic syndrome.

Reducing obesity indicators through brief physical activity counseling (PACE) in Italian primary care settings.

BACKGROUND: There is an alarming prevalence of obesity and sedentariness in Western countries. An ideal context for health promotion and preventive medicine seems to be the setting of primary care provided by the general practitioner (GP). PURPOSE: Therefore, this study evaluated the impact of GPs' brief physical activity counseling for overweight and obese patients. METHODS: Individuals recruited during routine physician visits were randomly split into an experimental (n = 48) group that received the Patient-centered Assessment and Counseling for Exercise (PACE) protocol, and a usual-care control (n = 48) group. Body mass index (BMI) and abdominal girth were assessed as objective biometrical parameters. Patients in the experimental group self-reported their readiness for physical activity and self-efficacy. RESULTS: The experimental group had significantly better BMI and abdominal girth compared with the control group after a 5- to 6-month follow-up. Furthermore, the experimental group progressed in their stage of physical activity readiness and increased their self-efficacy. CONCLUSIONS: The GPs' counseling for physical activity using the PACE protocol influenced mediators and biometrical outcomes in an Italian primary care context.