Step Monitoring to improve ARTERial health (SMARTER) through step count prescription in type 2 diabetes and hypertension: trial design and methods

BACKGROUND: With increasing numbers of type 2 diabetes (DM2) and hypertension patients, there is a pressing need for effective, time-efficient and sustainable strategies to help physicians support their patients to achieve higher physical activity levels. SMARTER will determine whether physician-delivered step count prescriptions reduce arterial stiffness over a one-year period, compared with usual care, in sedentary overweight/obese adults with DM2/hypertension. DESIGN: Randomized, allocation-concealed, assessor-blind, multisite clinical trial. The primary outcome is change in arterial stiffness over one year. The secondary outcomes include changes in physical activity, individual vascular risk factors, medication use, and anthropometric parameters. Assessments are at baseline and one year. METHODS: Participants are sedentary/low active adults with 25 ≤ BMI < 40 kg/m(2) followed for DM2/hypertension by a collaborating physician. The active arm uses pedometers to track daily step counts and review logs with their physicians at 3 to 4-month intervals. A written step count prescription is provided at each visit, aiming to increase counts by ≥3,000 steps/day over one year, with an individualized rate increase. The control arm visits physicians at the same frequency and receives advice to engage in physical activity 30-60 minutes/day. SMARTER will enroll 364 individuals to detect a 10 ± 5% difference in arterial stiffness change between arms. Arterial stiffness is assessed noninvasively with carotid femoral pulse wave velocity using applanation tonometry. DISCUSSION: The importance of SMARTER lies not simply in the use of pedometer-based monitoring but also on its integration into a prescription-based intervention delivered by the treating physician. Equally important is the measurement of impact of this approach on a summative indicator of arterial health, arterial stiffness. If effectiveness is demonstrated, this strategy has strong potential for widespread uptake and implementation, given that it is well-aligned with the structure of current clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01475201)