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Exercise is Medicine at Emory Seavey Internal Medicine Clinic (EIM)

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Emory University

Status

Completed

Conditions

Physical Activity

Treatments

Behavioral: Personalized Motivational Message
Behavioral: Wearable Device
Behavioral: App
Behavioral: Automated Motivational Message

Study type

Interventional

Funder types

Other

Identifiers

NCT03416634
IRB00101370

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • At least one documented cardiovascular disease risk factor
  • 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 unstable angina or myocardial infarction in the past 3 months without having finalized an initial cardiac rehabilitation program;
  • Documented end-stage renal disease or life-threatening disease;
  • Diagnosed major mental health disorder;
  • Alcohol or drug abuse.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

106 participants in 6 patient groups

App Alone
Active Comparator group
Description:
Participants randomized to use the Microsoft Band app to track daily activity
Treatment:
Behavioral: App
App Plus Automated Motivational Message
Experimental group
Description:
Participants randomized to use the Microsoft Band app to track daily activity, and to receive automated, motivational text messages
Treatment:
Behavioral: App
Behavioral: Automated Motivational Message
App Plus Personalized Motivational Message
Experimental group
Description:
Participants randomized to use the Microsoft Band app to track daily activity, and to receive personalized, motivational text messages
Treatment:
Behavioral: App
Behavioral: Personalized Motivational Message
Wearable Device Alone
Active Comparator group
Description:
Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity
Treatment:
Behavioral: Wearable Device
Wearable Device Plus Automated Motivational Message
Experimental group
Description:
Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive automated, motivational text messages
Treatment:
Behavioral: Automated Motivational Message
Behavioral: Wearable Device
Wearable Device Plus Personalized Motivational Message
Experimental group
Description:
Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive personalized, motivational text messages
Treatment:
Behavioral: Wearable Device
Behavioral: Personalized Motivational Message

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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