Exercise is Medicine at Emory Seavey Internal Medicine Clinic
Condition: Physical Activity
Study type: Interventional

Summary: 
      Implementation of physical activity promotion in routine health care delivery is low because
      of multiple barriers including insufficient health system support, care team coordination,
      and scarcity of community resources for referring patients and technology tools for
      sustaining lifestyle changes. This study is a pilot project to test the feasibility of
      implementing a physical activity promotion protocol, including routine evaluation of
      patient's physical activity levels and provision of educational material in the clinical
      workflow. Physically inactive adult patients with at least one documented cardiovascular
      disease risk factor will be invited to participate in physical activity intervention.
      Patients will be randomized to receive a wearable device or a smartphone app to objectively
      monitor their physical activity. Participants will be further randomized to receive automated
      motivational text messages, or a personalized motivational message, or no messages.
      Participants will be followed through the 12 week intervention period and an additional 12
      weeks with no intervention.
    

Detailed description: 
      Improving and maintaining health-enhancing levels of physical activity (PA) leads to
      reductions in the metabolic, hemodynamic, body composition, epi-genetic and functional status
      risk factors that heavily contribute to the development of many non-communicable chronic
      diseases. As such, PA has a significant role, in many cases comparable or superior to drug
      interventions, in the prevention and treatment of more than 40 diseases such as obesity,
      heart disease, diabetes, hypertension, cancer, depression, anxiety, arthritis, and
      osteoporosis.

      While conceptually simple, implementing clinical-community linkages for PA promotion is
      hindered by barriers at multiple levels such as inadequate training and self-efficacy among
      health care providers (HCPs), insufficient health system support and care team coordination,
      and scarcity of certified community resources for referring patients. The challenge for HCPs
      and health systems is how to operationalize, standardize, and implement PA promotion in a
      cost-effective and innovative fashion.

      This study is a pilot project to test the feasibility of implementing a physical activity
      promotion protocol including routine evaluation of patient's physical activity levels and
      provision of educational material in the clinical workflow of the Seavey Internal Medicine
      Clinic at Emory University. Physically inactive adult patients with at least one documented
      cardiovascular disease risk factor (overweight/obesity, dyslipidemia, hypertension, diabetes)
      but cleared for self-directed exercise by their treating clinician will be invited to
      participate in physical activity intervention. Patients will be randomized to receive a
      wearable device (Garmin vivofit 3) or a smartphone app (Microsoft Band) to objectively
      monitor their physical activity. Participants will be further randomized to receive automated
      motivational text messages, or a personalized motivational message, or no messages.
      Participants will be followed through the 12 week intervention period and an additional 12
      weeks with no intervention. The researchers will assess changes in objectively-measured
      physical activity (primary outcome) and explore impact on secondary outcomes including
      cardiovascular disease (CVD) risk factors (assessed routinely as part of clinical
      management), as well as self-reported mental health, quality of life and exercise
      self-efficacy using validated questionnaires.
    

Intervention name(s): App; Wearable Device; Automated Motivational Message; Personalized Motivational Message
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The Microsoft Band app can be installed for free on compatible smartphones. The app can be used to track steps while the phone is with the participant (such as in a pocket). Participants can synchronize their device with the study app to give permission to share physical activity level with the study team. Daily physical activity will be tracked for 24 weeks.; A Garmin vivofit 3 fitness device will be provided for free to participants randomized to this study arm. This wearable device tracks daily activity and gives reminders to move after an hour of inactivity. The battery lasts for one year and the device is water resistant. Participants can synchronize their device with the study App to give permission to share physical activity level with the study team. Daily physical activity will be tracked for 24 weeks.; An automated behavioral intervention will be delivered once weekly via an in-app motivational message, over the 12-week intervention period.; A behavioral intervention will be delivered once weekly via an in-app motivational message adapted to each patient's personalized PA goal progression based on the previous week data from the smartphone activity app (Microsoft band) or the Garmin wearable device over a 12-week intervention period.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 90 participants will use a wearable device and 90 will use a smartphone app to track activity. These groups will be further randomized to receive an automated motivational intervention, or a personalized motivational intervention or no additional intervention; each study arm will have 30 participants.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Health promotion; Behavioral research; Preventive medicine; Obesity; Cardiovascular disease