mActive: A Blinded, Randomized mHealth Activity Trial (mActive)

• ClinicalTrials.gov Identifier: NCT01917812
• Recruitment Status: Completed
• First Posted: August 7, 2013
• Results First Posted: January 5, 2016
• Last Update Posted: March 23, 2017
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Physical Activity	Device: Digital Activity Tracker; Other: Smart Text Messaging	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: mActive: A Blinded, Randomized mHealth Trial of Digital Activity Tracking and Smart Texting to Promote Physical Activity
• Study Start Date: January 2014
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Device: Digital Activity Tracker; Other Name: Fitbug Orb
Experimental: 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. 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.	Device: Digital Activity Tracker; Other Name: Fitbug Orb
Experimental: 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. 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.	Device: Digital Activity Tracker; Other Name: Fitbug Orb; Other: Smart Text Messaging

Outcome Measures

Primary Outcome Measures :

1. Mean Daily Step Count [ Time Frame: Change 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.
2. Mean Daily Step Count [ Time Frame: Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging 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 Outcome Measures :

1. Mean Daily Activity Time [ Time Frame: Change 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.
2. Mean Daily Aerobic Activity Time [ Time Frame: Change 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.

3. Mean Daily Activity Time [ Time Frame: Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging 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.
4. Mean Daily Aerobic Activity Time [ Time Frame: Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 69 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21202

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Study Director: Michael J Blaha, MD, MPH; Johns Hopkins University

More Information

Additional Information:

mActive: A Blinded, Randomized mHealth Trial Supporting Digital Tracking and Smart Texting for Promotion of Physical Activity. AHA EPI Scientific Sessions Presentation Slides. 

Publications of Results:

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). pii: e002239. doi: 10.1161/JAHA.115.002239.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01917812
• Other Study ID Numbers: NA_00086400
• First Posted: August 7, 2013
• Results First Posted: January 5, 2016
• Last Update Posted: March 23, 2017
• Last Verified: February 2017

Keywords provided by Johns Hopkins University:

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