Exercise is Medicine at Emory Seavey Internal Medicine Clinic
NCT ID: NCT03416634
Last Updated: 2020-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2018-08-20
2020-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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App Alone
Participants randomized to use the Microsoft Band app to track daily activity
App
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.
App Plus Automated Motivational Message
Participants randomized to use the Microsoft Band app to track daily activity, and to receive automated, motivational text messages
App
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.
Automated Motivational Message
An automated behavioral intervention will be delivered once weekly via an in-app motivational message, over the 12-week intervention period.
App Plus Personalized Motivational Message
Participants randomized to use the Microsoft Band app to track daily activity, and to receive personalized, motivational text messages
App
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.
Personalized Motivational Message
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.
Wearable Device Alone
Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity
Wearable Device
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.
Wearable Device Plus Automated Motivational Message
Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive automated, motivational text messages
Wearable Device
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.
Automated Motivational Message
An automated behavioral intervention will be delivered once weekly via an in-app motivational message, over the 12-week intervention period.
Wearable Device Plus Personalized Motivational Message
Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive personalized, motivational text messages
Wearable Device
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.
Personalized Motivational Message
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.
Interventions
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App
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.
Wearable Device
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.
Automated Motivational Message
An automated behavioral intervention will be delivered once weekly via an in-app motivational message, over the 12-week intervention period.
Personalized Motivational Message
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.
Eligibility Criteria
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Inclusion Criteria
* Not meeting physical activity (PA) guidelines (aerobic and/or muscle-strengthening standards)
* contemplating PA engagement
* Non-wheelchair bound (other assist devices will be acceptable) or major physical limitations for PA
* Cleared for independent PA by their health care provider
* Willingness to participate and provide written informed consent
* Report access to a mobile phone with data plan and/or computer with internet access
* Agrees to not own/use a different PA wearable device during the study period.
Exclusion Criteria
* Documented end-stage renal disease or life-threatening disease;
* Diagnosed major mental health disorder;
* Alcohol or drug abuse.
20 Years
80 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Sharon Horesh Bergquist
Assistant Professor
Principal Investigators
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Sharon Bergquist, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Roberto Felipe Lobelo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Paul W. Seavey Internal Medicine Clinic
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00101370
Identifier Type: -
Identifier Source: org_study_id
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