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

February 17, 2017 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Fitbug Orb
Other: Smart Text Messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)
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.
Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)
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.
Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)
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.
Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)
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.
Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NA_00086400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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