Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917812


Locations
Layout table for location information
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21202
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Study Director: Michael J Blaha, MD, MPH Johns Hopkins University

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01917812    
Other Study ID Numbers: NA_00086400
First Posted: August 7, 2013    Key Record Dates
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