Physical Activity Clinical Trial
Official title:
Exercise is Medicine (EIM): A Quality Improvement and Pragmatic Trial at Emory Seavey Internal Medicine Clinic
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.
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.
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