mActive: A Blinded, Randomized mHealth Activity Trial

NCT01917812 | Completed Results

• 1 other identifier: NA_00086400
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (4)

• Mean Daily Activity Time

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

• Mean Daily Aerobic Activity Time

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

• Mean Daily Activity Time

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

• Mean Daily Aerobic Activity Time

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

Study Arms (3)

Blinded Digital Activity Tracker

PLACEBO COMPARATOR

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

Unblinded Digital Activity Tracker / No Smart Text Messaging

EXPERIMENTAL

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

Unblinded Digital Activity Tracker / Smart Text Messaging

EXPERIMENTAL

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: Smart Text Messaging

Interventions

Digital Activity Tracker DEVICE

Also known as: Fitbug Orb

Blinded Digital Activity Tracker; Unblinded Digital Activity Tracker / No Smart Text Messaging; Unblinded Digital Activity Tracker / Smart Text Messaging

Smart Text Messaging OTHER

Unblinded Digital Activity Tracker / Smart Text Messaging

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• days or more of moderate or vigorous activity during leisure time for 30 minutes of more per day by International Physical Activity Questionnaire

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21202, United States

Location

Related 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. 2015 Nov 9;4(11):e002239. doi: 10.1161/JAHA.115.002239.

  PMID: 26553211 RESULT

Related Links

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

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

Given its limited size and scope, mActive may be categorized as a pilot trial. As such, it is most appropriately interpreted as exploratory evidence to guide a definitive pivotal trial in the future.

Results Point of Contact

• Title: Dr. Seth S Martin
• Organization: Johns Hopkins University School of Medicine

smart100@jhmi.edu

410-955-7376

Study Officials

• Michael J Blaha, MD, MPH

  Johns Hopkins University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 7, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 23, 2017
• Results First Posted: January 5, 2016

Record last verified: 2017-02

Locations

US (1)