mActive: A Blinded, Randomized mHealth Activity Trial

Physical Activity Clinical Trial

— mActive  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917812
• Other study ID #: NA_00086400
• Status: Completed
• Phase: N/A
• First received: August 1, 2013
• Last updated: January 4, 2016
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Activity

Intervention

Device:
• Digital Activity Tracker

Other:
• Smart Text Messaging

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)	No
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.	Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)	No
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.	Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)	No
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.	Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)	No
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.	Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)	No
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.	Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)	No

External Links

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