Physical ActivitymActiveNCT01917812
mActive: A Blinded, Randomized mHealth Activity Trial
A study testing Digital Activity Tracker and Smart Text Messaging in people with Physical Activity, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Physical Activity
- What is being tested?
- Digital Activity Tracker and Smart Text Messaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting to cardiology clinic
- Aged 18-69 years
- User of a compatible smartphone
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- individuals overestimate their physical activity, especially that done at work.
- biofeedback from an activity tracker can increase physical activity via increasing self-awareness.
- "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.
- Conditions
- Physical Activity
- Being tested
- Digital Activity Tracker, Smart Text Messaging
- Keywords
- physical activity, exercise, mHealth, smartphone, activity tracker, pedometer, text messaging, SMS
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Activity TrackerDevice
Also called Fitbug Orb
Smart Text MessagingOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Digital Activity Tracker; Other: Smart Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)
Secondary outcomes (4)
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.
Measured: Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)
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.
Measured: Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)
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.
Measured: Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)
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.
Measured: Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Blaha, MD, MPH, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917812
- Sponsor's protocol ID
- NA_00086400
- Acronym
- mActive
- Status last verified
- Feb 2017
- First submitted
- 1 Aug 2013
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26553211
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mActive: A Blinded, Randomized mHealth Trial of Digital Activity Tracking and Smart Texting to Promote Physical Activity
- ClinicalTrials.gov ID
- NCT01917812
- Acronym / sponsor ID
- mActive / NA_00086400
- Conditions
- Physical Activity
- Keywords
- physical activity, exercise, mHealth, smartphone, activity tracker, pedometer, text messaging, SMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Posted 5 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- individuals overestimate their physical activity, especially that done at work.
- biofeedback from an activity tracker can increase physical activity via increasing self-awareness.
- "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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blinded Digital Activity Tracker | Placebo comparator | Device: Digital Activity TrackerBlinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker. |
| Unblinded Digital Activity Tracker / No Smart Text Messaging | Experimental | Device: Digital Activity TrackerUnblinded 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. |
| Unblinded Digital Activity Tracker / Smart Text Messaging | Experimental | Device: Digital Activity Tracker, Other: Smart Text MessagingUnblinded 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presenting to cardiology clinic
- Aged 18-69 years
- User of a compatible smartphone
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Activity TrackerAlso: Fitbug Orb | Device | 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 |
Primary outcome
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.
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.
4 secondary outcomes
Mean Daily Activity Time
Time frame: 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)
Mean Daily Activity Time
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26553211Martin 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.
- mActive: A Blinded, Randomized mHealth Trial Supporting Digital Tracking and Smart Texting for Promotion of Physical Activity. AHA EPI Scientific Sessions Presentation Slides.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Blaha, MD, MPH study director
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Activity Tracker and Smart Text Messaging in people with Physical Activity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Daily Step Count (time frame: Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01917812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.