Clinical trial NCT03416634: Exercise is Medicine at Emory Seavey Internal Medicine Clinic
Official title: Exercise is Medicine (EIM): A Quality Improvement and Pragmatic Trial at Emory Seavey Internal Medicine Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Health promotion
Behavioral research
Preventive medicine
Obesity
Cardiovascular disease
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Physical Activity
timeFrame: Baseline through Week 24
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline through Week 24
measure: Change in triglycerides
timeFrame: Baseline through Week 24
measure: Change in total cholesterol
timeFrame: Baseline through Week 24
measure: Change in hypertension status
timeFrame: Baseline through Week 24
measure: Change in blood glucose
timeFrame: Baseline through Week 24
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: Baseline through Week 24
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
timeFrame: Baseline, Week 12, Week 24
measure: Change in Eating Habits Confidence Survey Score
timeFrame: Baseline, Week 12, Week 24
measure: Change in Exercise Confidence Survey Score
timeFrame: Baseline, Week 12, Week 24
measure: Change in Social Support and Exercise Survey Score
timeFrame: Baseline, Week 12, Week 24
measure: Change in Short-Form Patient Satisfaction Questionnaire (PSQ-18) Score
timeFrame: Baseline, Week 12, Week 24
measure: Change in 12-Item Short-Form Health Survey (SF-12) Score
timeFrame: Baseline, Week 12, Week 24
measure: Change in 36-Item Short-Form Health Survey (SF-36) Score
timeFrame: Baseline, Week 12, Week 24
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Paul W. Seavey Internal Medicine Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Sharon Bergquist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Roberto Felipe Lobelo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: