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Despite their importance, health-related behaviors are hard to change. Among behaviors, physical activity is associated with protection from multiple diseases. People who are physically active have lower risk for heart disease, stroke, type 2 diabetes, depression, and some cancers with associated dose-dependent reductions in cardiovascular and all-cause mortality. However, most US adults do not meet CDC physical activity guidelines. Sedentary work behavior in industrialized nations is likely a contributor to this problem.
Current low-technology strategies for encouraging lifestyle change are disappointingly ineffective and are highly resource intensive. Systematic reviews of the literature show mixed evidence for using activity trackers (i.e., pedometers) and a limited body of evidence for text messaging in preventive health care. However, prior studies have not integrated digital activity tracking with mobile phone text messaging feedback.
Given 91% of adults in the United States now use a mobile phone, and 56% a smartphone, this represents a potentially widely applicable avenue for therapeutic intervention. There is growing interest in leveraging mobile health (mHealth) technologies to improve health behaviors in the general population. The investigators propose to conduct a blinded, randomized mHealth trial of digital activity tracking and smart texting to promote physical activity.
Using an innovative, convenient, mHealth trial design, this pilot study aims to test the feasibility of a seamless model of information flow integrating digital activity tracker information with a mobile phone texting system to deliver a technology-enhanced intervention that does not require in-person follow-up.
The investigators hypothesize that:
Digitalized activity tracking will use the Fitbug Orb, which syncs via Bluetooth with one's smartphone. It is a display-free triaxial accelerometer, allowing one to blind participants to numeric feedback. Text messaging will use Reify Health's "smart" platform for personalized, interactive texting by an automated and repeatable algorithm. Texting will be informed by real-time activity information.
Potential advantages of the trial strategy include elimination of attendance at in-person sessions, personalization of health coaching, more continuous patient contact; inexpensive intervention, the ultimate ability to scale our intervention to larger target populations.
After initial pilot trial completion, additional study will include long-term physical activity follow-up of participants and focus groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded Digital Activity Tracker | Placebo Comparator | Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker. |
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| Unblinded Digital Activity Tracker / No Smart Text Messaging | Experimental | Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker. No Smart Text Messaging = Group does not receive personalized, health coaching via "smart" text messages. Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. |
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| Unblinded Digital Activity Tracker / Smart Text Messaging | Experimental | Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker. Smart Text Messaging = Group receives personalized, health coaching via "smart" text messages. Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Activity Tracker | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Step Count | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention) |
| Mean Daily Step Count | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Activity Time | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Blaha, MD, MPH | Johns Hopkins University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26553211 | Result | Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, Coresh J, Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity Promotion. J Am Heart Assoc. 2015 Nov 9;4(11):e002239. doi: 10.1161/JAHA.115.002239. |
| Label | URL |
|---|---|
| mActive: A Blinded, Randomized mHealth Trial Supporting Digital Tracking and Smart Texting for Promotion of Physical Activity. AHA EPI Scientific Sessions Presentation Slides. | View source |
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We enrolled outpatients at an academic cardiovascular prevention center (Johns Hopkins Ciccarone Center) in Baltimore, Maryland, USA from January 17 to May 20, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Blinded Digital Activity Tracker | Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker. Blinded Digital Activity Tracker |
| FG001 | Unblinded Digital Activity Tracker / No Smart Text Messaging | Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker. No Smart Text Messaging = Group does not receive personalized, health coaching via "smart" text messages. Unblinded Digital Activity Tracker |
| FG002 | Unblinded Digital Activity Tracker / Smart Text Messaging | Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker. Smart Text Messaging = Group receives personalized, health coaching via "smart" text messages. Unblinded Digital Activity Tracker Smart Text Messaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Blinded Digital Activity Tracker | Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker. Blinded Digital Activity Tracker |
| BG001 | Unblinded Digital Activity Tracker / No Smart Text Messaging |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Daily Step Count | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Posted | Mean | Standard Deviation | steps per day | Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blinded Digital Activity Tracker | Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker. Blinded Digital Activity Tracker |
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Given its limited size and scope, mActive may be categorized as a pilot trial. As such, it is most appropriately interpreted as exploratory evidence to guide a definitive pivotal trial in the future.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Seth S Martin | Johns Hopkins University School of Medicine | 410-955-7376 | smart100@jhmi.edu |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Smart Text Messaging | Other |
|
| Mean Daily Aerobic Activity Time | Defined as the time spent walking continuously for >10 minutes without breaking for more than a minute. Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention) |
| Mean Daily Activity Time | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention) |
| Mean Daily Aerobic Activity Time | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention) |
Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker. Unblinded Digital Activity Tracker |
| BG002 | Unblinded Digital Activity Tracker / Smart Text Messaging | Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker. Smart Text Messaging = Group receives personalized, health coaching via "smart" text messages. Unblinded Digital Activity Tracker Smart Text Messaging |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Counts |
|---|
| Participants |
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| Secondary | Mean Daily Activity Time | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Posted | Mean | Standard Deviation | minutes per day | Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention) |
|
|
|
| Secondary | Mean Daily Aerobic Activity Time | Defined as the time spent walking continuously for >10 minutes without breaking for more than a minute. Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Posted | Mean | Standard Deviation | minutes per day | Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention) |
|
|
|
| Primary | Mean Daily Step Count | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Posted | Mean | Standard Deviation | steps per day | Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention) |
|
|
|
| Secondary | Mean Daily Activity Time | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Posted | Mean | Standard Deviation | minutes per day | Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention) |
|
|
|
| Secondary | Mean Daily Aerobic Activity Time | Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts. | Posted | Mean | Standard Deviation | minutes per day | Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention) |
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Unblinded Digital Activity Tracker / No Smart Text Messaging | Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker. Unblinded Digital Activity Tracker | 0 | 16 | 0 | 16 |
| EG002 | Unblinded Digital Activity Tracker / Smart Text Messaging | Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker. Smart Text Messaging = Group receives personalized, health coaching via "smart" text messages. Unblinded Digital Activity Tracker Smart Text Messaging | 0 | 16 | 0 | 16 |
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