Exercise is Medicine at Emory Seavey Internal Medicine Clinic

NCT03416634 | Completed

• 1 other identifier: IRB00101370
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Keywords

Health promotion; Behavioral research; Preventive medicine; Obesity; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity

  Physical activity will be measured through the Microsoft Band app or with the Garmin vivofit 3. The physical activity of the participants will be monitored during the 12 week intervention period (when some study arms will receive motivational messages) and through 12 additional weeks of follow up.

  Baseline through Week 24

Secondary Outcomes (13)

• Change in weight

  Baseline through Week 24

• Change in triglycerides

  Baseline through Week 24

• Change in total cholesterol

  Baseline through Week 24

• Change in hypertension status

  Baseline through Week 24

• Change in blood glucose

  Baseline through Week 24

Study Arms (6)

App Alone

ACTIVE COMPARATOR

Participants randomized to use the Microsoft Band app to track daily activity

Behavioral: App

App Plus Automated Motivational Message

EXPERIMENTAL

Participants randomized to use the Microsoft Band app to track daily activity, and to receive automated, motivational text messages

Behavioral: App; Behavioral: Automated Motivational Message

App Plus Personalized Motivational Message

EXPERIMENTAL

Participants randomized to use the Microsoft Band app to track daily activity, and to receive personalized, motivational text messages

Behavioral: App; Behavioral: Personalized Motivational Message

Wearable Device Alone

ACTIVE COMPARATOR

Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity

Behavioral: Wearable Device

Wearable Device Plus Automated Motivational Message

EXPERIMENTAL

Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive automated, motivational text messages

Behavioral: Wearable Device; Behavioral: Automated Motivational Message

Wearable Device Plus Personalized Motivational Message

EXPERIMENTAL

Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive personalized, motivational text messages

Behavioral: Wearable Device; Behavioral: Personalized Motivational Message

Interventions

App BEHAVIORAL

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 Alone; App Plus Automated Motivational Message; App Plus Personalized Motivational Message

Wearable Device BEHAVIORAL

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 Alone; Wearable Device Plus Automated Motivational Message; Wearable Device Plus Personalized Motivational Message

Automated Motivational Message BEHAVIORAL

An automated behavioral intervention will be delivered once weekly via an in-app motivational message, over the 12-week intervention period.

App Plus Automated Motivational Message; Wearable Device Plus Automated Motivational Message

Personalized Motivational Message BEHAVIORAL

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.

App Plus Personalized Motivational Message; Wearable Device Plus Personalized Motivational Message

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Paul W. Seavey Internal Medicine Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Motor Activity; Obesity; Cardiovascular Diseases

Interventions

Amyloid; Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Sharon Bergquist, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Roberto Felipe Lobelo, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: August 20, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

US (1)