Step Monitoring to Improve ARTERial Health
Condition: Type 2 Diabetes; Hypertension
MeSH terms: Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Many people with diabetes and/or high blood pressure (hypertension) are not very active. When
      people are more active, they can reduce the chances of having a heart attack or stroke.
      Walking more is a cheap and effective way to be more active and to lower the risk of heart
      attacks and strokes. The problem is that many people do not walk enough! The investigators
      will study if people with diabetes and/or hypertension walk more when the doctor gives them a
      prescription with the number of steps they should be walking every day. The investigators
      will compare this group, called 'active', to another group, called 'control', in which
      doctors and their patients do what they usually do, over a period of one year.

      The investigators will measure the number of steps the investigators walk everyday with a
      step counter or pedometer. In the step count prescription group, the doctors will give to the
      'active' group a pedometer, a step count record book, and step count prescriptions. The
      overall goal is to gradually increase daily steps. The speed of the increase in step count
      will be slower for less active people. At each visit the doctor will look at the step count
      record book. The doctor will then give a new step count prescription to the patients.
      Patients of the two groups will see their doctor about four times during the year, which is
      how often they usually see their doctor. At the end of one year, the investigators will see
      the difference in the hardness of the arteries between the 'active' and the 'control' groups,
      using simple and safe measurements, similar to ultrasound in pregnant ladies. People with
      hard arteries are more likely to have a heart attack or stroke.

      The investigators suspect that patients who get the step count prescriptions will walk more
      and their arteries will be less hard than the control group. Our study will help find out if
      this is true. In that case, doctors should take the time to prescribe steps for all their
      patients with diabetes and/or hypertension.
    

Detailed description: 
      BACKGROUND: High walking levels reduce myocardial infarction, stroke, and mortality rates in
      overweight/obese patients with diabetes and/or hypertension, but our own work, led by
      Nominated Principal Applicant K. Dasgupta, indicates low daily step counts in these patients,
      at approximately 5,000 steps/day on average with a further 15% reduction during fall and
      winter. A meta-analysis of physical activity programs indicates that pedometer-based
      monitoring programs can lead to higher daily step counts, but evidence for impact on arterial
      health is limited, as is evidence for the effectiveness of a pedometer-based strategy
      specifically implemented into the usual clinical care of patients with diabetes and/or
      hypertension. The SMARTER trial will address these knowledge gaps.

      PRIMARY RESEARCH QUESTION: Among sedentary overweight/obese adults with diabetes and/or
      hypertension do physician-delivered step count prescriptions integrated into usual care
      reduce arterial stiffness more than usual care alone, over a one-year period? Arterial
      stiffness (primary outcome), a summative indicator of arterial health, is more precise and
      reliable than individual risk factors. An analysis of the Framingham Heart Study demonstrated
      that, even after adjustment for traditional risk factors, increased arterial stiffness was
      independently associated with a 48% increase in vascular disease risk. Co-Principal Applicant
      S. Daskalopoulou is an expert in the noninvasive assessment of arterial stiffness and has a
      well-equipped Vascular Lab funded through a CFI grant.

      STUDY DESIGN: Randomized, allocation concealed, single-blind (outcome assessors),
      intervention allocation ratio 1:1, multisite clinical trial. This design will allow for the
      level A evidence necessary to justify widespread change in clinical practice.

      TRIAL SYNOPSIS: Given that the majority of diabetes and hypertension patients are managed in
      primary care settings, the SMARTER trial interventions will be delivered through the large
      network of primary care clinics accessible to Co-Principal Applicant E. Rosenberg as well as
      diabetes and internal medicine clinics throughout Montreal where patients may receive their
      primary diabetes and hypertension follow-up. Twenty-four collaborating physicians have been
      identified. Physicians/clinic staff will obtain assent from candidates within their practice
      for contact by the SMARTER coordinator. The number of collaborating physicians continues to
      be increased, including physicians at primary care, diabetes, hypertension, internal
      medicine, and endocrinology clinics. Eligibility: Candidates will be adults with 25≤BMI<40
      kg/m2 followed for diabetes and/or hypertension and sedentary to somewhat active.
      Evaluations: Formal trial evaluations, conducted at baseline and 12 months, will include
      assessments of arterial stiffness (carotid femoral pulse wave velocity measured noninvasively
      with applanation tonometry); step counts (pedometer with concealed window) and physical
      activity (accelerometer) worn for one week; fitness (exercise stress test; ˙VO2max);
      anthropometric parameters; and individual vascular risk factors. Intervention arm: The
      physician gives the active trial participants a pedometer, log book, and a step count
      prescription based on the baseline daily step count. The time frame for a > 3,000 steps/day
      net increase is 10 months for sedentary participants (<5,000 steps/day), 7 months for low
      active participants (5,000-7,499 steps/day), and 5 months for somewhat active participants
      (7,500-9,999 steps/day). There will be four clinic visits over one year. Control arm: Same
      visit frequency with advice to engage in 30-60 minutes of activity on most days of the week.
      Sample Size: Allowing for a loss to follow-up of up to 17% based on our previous studies,
      investigators will require a sample size of 364 individuals (i.e. 182 per arm) to detect a
      10% difference in change in arterial stiffness between our active and control arms to an
      accuracy of +/- 5% over a one-year period. Analysis: Intention-to-treat. Between-arm
      differences in 'after minus before changes' with 95% CIs for main analysis.

      Addedum to stress testing: Due to timeline limitations, we were obliged to forego stress
      testing assessments as of October 20, 2014. This does not impact our primary outcome.
      Moreover, stress testing is not required when engaging in a walking program in type 2
      diabetes. We will be able to assess impacts of the intervention on fitness (secondary
      outcome) in a subgroup of patients (i.e., those who completed assessments before October 20,
      2014).

      IMPORTANCE: With increasing numbers of diabetes and hypertension patients, there is a
      pressing need for effective and efficient clinical practice strategies to help physicians
      support their patients to achieve the arterial health benefits of higher physical activity
      levels. The SMARTER trial seeks to provide such a tool. If effectiveness is demonstrated, all
      efforts will be made for the inclusion of our approach in Clinical Practice Guidelines for
      diabetes and hypertension, and investigators will develop training tools (manuals, websites,
      CD-ROMs) to allow maximal uptake of our proposed strategy.

      AN OBSERVATIONAL SUBSTUDY: Novel Real-Time Measurement of Physical Activity Patterns in Type
      2 Diabetes and Hypertension Through GPS Monitoring and Accelerometry

      In addition to the main clinical trial, we are conducting additional measurements among
      consenting type 2 diabetes patients in order to examine the effects of the walkability of
      their home neighbourhood on their baseline step count and time at different physical activity
      intensities (accelerometer measurement already being performed through SMARTER). The
      additional measurements include wearing a Geographical Positioning Systems (GPS) device for
      the 7-day period that they wear the pedometer with concealed viewing window and
      accelerometer. The GPS device collects time-stamped location information such that X,Y
      coordinates are collected. These are used to determine the times that they are within or
      outside neighbourhood buffer zones.

      For the assessment of neighbourhood walkability,the parameters assessed include population
      density, pedestrian-friendly design and diversity of destinations - commonly referred to in
      the urban planning literature as the 3D's. The variables that best capture density, design,
      and diversity include residential density, street connectivity and land use mix. Residential
      density is defined as the number of residences per square kilometre of residential land area.
      Street connectivity is defined as the number of ≥3-way intersections per square kilometre in
      neighbourhood, where a greater number of intersections facilitates movement between origins
      (e.g., residences) and destinations (e.g., shops and parks).Land-use mix is a measure of the
      number of different land uses located within a neighbourhood.Land use mix is assessed via an
      entropy score - a value between zero and one that captures the degree of heterogeneity of
      land uses in a neighbourhood. A subcomponent of land use mix that may be a particularly
      important for encouraging individuals to walk within their neighbourhood and that is easily
      incorporated into the design of new neighbourhoods is greenspace/recreational land area.

      We are using Geographical Information System (GIS) mapping (computer-based assessment of
      neighbourhood characteristics derived from existing data sources that have some spatially
      referenced identification, such as a home address) to measure these facets of neighbourhood
      walkability.In brief, each of the variables will be derived by geocoding participants
      six-digit home postal codes, constructing 1-kilometre polygonal buffers zones around each
      participants home address (i.e., a geographical zone around the centroid of the postal code
      area) and calculating the measures of interest for each neighbourhood using tools within a
      GIS software package (ArcGIS) and publically available shape files.

      Means and standard deviations will be used to describe the number of steps per day occurring
      specifically in home neighbourhoods (i.e., as determined through GPS) and overall. Multiple
      linear regression analyses will be used to assess the relationship between 1) home
      neighbourhood environments and the number of steps taken per day in the home neighbourhood
      and 2) home neighbourhood environments and the number of steps taken per day taken in any
      location. These analyses will be repeated with time at moderate to vigorous activity in lieu
      of steps as the outcome variable. Several variables measured through SMARTER will be
      considered for exclusion in models (e.g., age, sex, educational level, BMI).

      This observational substudy is partly funded by an operating grant from the Heart and Stroke
      Foundation (Quebec) awarded to K. Dasgupta (Principal Investigator) and Nancy Ross
      (Co-Principal Investigator on substudy) and is being led by Samantha Hajna, their doctoral
      candidate student.
    

Intervention name(s): Step count prescription; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treating physicians will provide a pedometer, pedometer log, and step count prescription. The aim is a net increase of at least 3,000 steps/day over one year. The time frame for this increase will be 10 months for sedentary participants (<5,000 steps/day), 7 months for low active participants (5,000-7,499 steps/day), and 5 months for somewhat active participants (7,500-9,999 steps/day). If goals are not met, the doctor and participant will review barriers and facilitators, and a more individualized prescription will be formulated (e.g. lower incremental step count targets or slower rate of dose escalation). For participants who meet goals, the doctor and participant will together decide whether to aim for a further increase.; The control trial arm will receive usual care alone, over a one-year period (i.e. no step count prescription but, in accordance with guidelines, including advice to engage in 30-60 minutes of activity on most days of the week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Hypertension; Primary Care; Physical Activity; Behavioural Intervention; Pedometer; Accelerometer; Arterial Stiffness; Carotid femoral pulse wave velocity; Vascular disease risk; Vascular disease prevention; Intervention