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mActive: A Blinded, Randomized mHealth Activity Trial

mActive: A Blinded, Randomized mHealth Trial of Digital Activity Tracking and Smart Texting to Promote Physical Activity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01917812
Acronym
mActive
Enrollment
48
Registered
2013-08-07
Start date
2014-01-31
Completion date
2014-06-30
Last updated
2017-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity

Keywords

physical activity, exercise, mHealth, smartphone, activity tracker, pedometer, text messaging, SMS

Brief summary

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.

Detailed description

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: 1. individuals overestimate their physical activity, especially that done at work. 2. biofeedback from an activity tracker can increase physical activity via increasing self-awareness. 3. smart text message feedback can increase physical activity via personalizing health coaching. 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.

Interventions

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* Presenting to cardiology clinic * Aged 18-69 years * User of a compatible smartphone

Exclusion criteria

* Already using an activity tracker * Preferred form of activity is not measured by an activity tracker(swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading) * Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting pulmonary disease, activity-limiting angina, activity-limiting osteoarthritis, or other condition. * 3 days or more of moderate or vigorous activity during leisure time for 30 minutes of more per day by International Physical Activity Questionnaire

Design outcomes

Primary

MeasureTime frameDescription
Mean Daily Step CountChange from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)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.

Secondary

MeasureTime frameDescription
Mean Daily Activity TimeChange from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)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.
Mean Daily Aerobic Activity TimeChange from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)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.

Countries

United States

Participant flow

Recruitment details

We enrolled outpatients at an academic cardiovascular prevention center (Johns Hopkins Ciccarone Center) in Baltimore, Maryland, USA from January 17 to May 20, 2014.

Participants by arm

ArmCount
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
16
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
16
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
16
Total48

Baseline characteristics

CharacteristicBlinded Digital Activity TrackerUnblinded Digital Activity Tracker / No Smart Text MessagingUnblinded Digital Activity Tracker / Smart Text MessagingTotal
Age, Continuous60 years
STANDARD_DEVIATION 7
58 years
STANDARD_DEVIATION 8
55 years
STANDARD_DEVIATION 8
58 years
STANDARD_DEVIATION 8
Region of Enrollment
United States
16 participants16 participants16 participants48 participants
Sex: Female, Male
Female
7 Participants7 Participants8 Participants22 Participants
Sex: Female, Male
Male
9 Participants9 Participants8 Participants26 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 160 / 160 / 16
serious
Total, serious adverse events
0 / 160 / 160 / 16

Outcome results

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.

Time frame: Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)

ArmMeasureValue (MEAN)Dispersion
Blinded Digital Activity TrackerMean Daily Step Count-616 steps per dayStandard Deviation 2385
Unblinded Digital Activity TrackerMean Daily Step Count408 steps per dayStandard Deviation 2701
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.

Time frame: Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)

ArmMeasureValue (MEAN)Dispersion
Blinded Digital Activity TrackerMean Daily Step Count-1042 steps per dayStandard Deviation 2202
Unblinded Digital Activity TrackerMean Daily Step Count-200 steps per dayStandard Deviation 1653
Unblinded Digital Activity Tracker / Smart Text MessagingMean Daily Step Count2334 steps per dayStandard Deviation 1714
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.

Time frame: Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)

ArmMeasureValue (MEAN)Dispersion
Blinded Digital Activity TrackerMean Daily Activity Time-6 minutes per dayStandard Deviation 26
Unblinded Digital Activity TrackerMean Daily Activity Time2 minutes per dayStandard Deviation 27
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.

Time frame: Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)

ArmMeasureValue (MEAN)Dispersion
Blinded Digital Activity TrackerMean Daily Activity Time-8 minutes per dayStandard Deviation 23
Unblinded Digital Activity TrackerMean Daily Activity Time0 minutes per dayStandard Deviation 17
Unblinded Digital Activity Tracker / Smart Text MessagingMean Daily Activity Time21 minutes per dayStandard Deviation 20
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.

Time frame: Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)

ArmMeasureValue (MEAN)Dispersion
Blinded Digital Activity TrackerMean Daily Aerobic Activity Time-11 minutes per dayStandard Deviation 14
Unblinded Digital Activity TrackerMean Daily Aerobic Activity Time-3 minutes per dayStandard Deviation 12
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.

Time frame: Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)

ArmMeasureValue (MEAN)Dispersion
Blinded Digital Activity TrackerMean Daily Aerobic Activity Time-3 minutes per dayStandard Deviation 10
Unblinded Digital Activity TrackerMean Daily Aerobic Activity Time-1 minutes per dayStandard Deviation 8
Unblinded Digital Activity Tracker / Smart Text MessagingMean Daily Aerobic Activity Time13 minutes per dayStandard Deviation 11

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026