Table 2.

Main outcome measures

Effectiveness in the optimisation of clinical practice for the primary prevention of T2D (experimental comparison)
Measures	Timing and Source
Coverage: Screening indicators (depending on the screening strategy selected by the centre)
Case 1 : T2D screening as part of opportunistic screening for cardiovascular risk in individuals aged ≥45 years or ≥30 years with at least one known risk factor: • % of non-diabetic patients aged ≥30 years with a cardiovascular risk factor (e.g., hypertension or BMI ≥30 kg/m2 or hyperglycaemia) attending to family doctor office in whom clinical practice guidelines are followed in terms of T2D screening using fasting glucose levels in the previous year; • % of non-diabetic patients aged ≥45 years with no cardiovascular risk factor attending to family doctor office in whom clinical practice guidelines are followed in terms of T2D screening using fasting glucose levels in the previous 4 years.
Case 2 : T2D screening based on a BMI≥25 kg/m2 in individuals aged 40 to 70 years: • % of non-diabetic patients aged between 40 and 70 years attending to family doctor’s office whose BMI has been measured in the previous year, 12 months after the introduction of the T2D prevention programme in the centres;	Baseline and 12 months after the setting up of the programme
• % of non-diabetic patients aged between 40 and 70 years attending to family doctor’s office with a BMI≥25 kg/m2 who have been screened for T2D using fasting glucose in the previous year, 12 months after the introduction of the T2D prevention programme in the centres.	Electronical Health Record
Implementation: Execution of the elements of the intervention programme in high risk patients defined by the presence of prediabetes (fasting glucose 110-125 mg/dl)
•% of patients whose physical activity levels and diet have been assessed, after the identification of T2D risk; •% of patients who have been given preventative advice concerning the need to increase physical activity and eat a healthy diet, after the identification of T2D risk;
•% of patients who have been prescribed a plan for increasing physical activity and eating a healthy diet, after the identification of T2D risk;	Baseline and 12 months after the setting up of the programme
•% of high risk patients (fasting glucose 110-125 mg/dl) who have undergone annual testing of fasting glucose and HbA1c.	Electronical Health Record
Maintenance: Long-term execution of the healthy lifestyles promotion programme in T2D high risk patients
•Level of screening coverage among candidate patients (e.g., % of patients with screening for T2D) •Level of execution of the clinical intervention elements (e.g., % of pre-diabetic patients who have received a prescription for lifestyle change) 24 months the introduction of the programme	0 to 24 months after the setting up of the programme (monthly rate)
•Monthly rate of the change in the coverage and execution of intervention elements for the promotion of healthy lifestyles over a 24-month period.	Electronical Health Record
Spreading: healthy lifestyles promotion actions in attending patients who do not meet the criteria of high risk of T2D (e.g., overweight or obese patients with normal glucose levels).
•% of patients whose physical activity levels and diet have been assessed, from those attending aged 10 to 80 years;
•% of patients who have been given preventative advice concerning the need to increase physical activity and eat a healthy diet, from those attending aged 10 to 80 years;	Baseline, 12 and 24 months after the setting up of the programme
•% of patients who have been prescribed a plan for increasing physical activity and eating a healthy diet, from those attending aged 10 to 80 years;	Electronical Health Record
Secondary outcome measures: clinical effectiveness of the intervention (observational comparison)
Change in healthy lifestyles and cardiovascular risk factors of high risk patients exposed to the intervention programme 12 months after exposure
• Adherence to recommendations on physical activity and healthy diet:
i) % who meet the recommended level of physical activity (150 min/week of moderate physical activity or 75 min/week of intense physical activity) , among those who did not meet it at recruitment;	Baseline and 12 months after programme exposure
ii) % who meet the recommended level of fruit and vegetable intake (5 portions/day), among those who did not meet it at recruitment. •Changes in physical activity (minutes of moderate to vigorous physical activity) or in fruit and vegetable intake
• % whose BMI decreases by 5% by 12 months after the intervention • potential effects of the preventative intervention on other cardiovascular factors including cholesterol and triglyceride levels, as well as BMI and blood glucose (data derived from the annual clinical follow-up)	Electronical Health Record

Bolded text refers to the outcome dimensions composed of multiple indicators

Underlined text refers to possible T2D risk screening strategies to be adopted by centres