Trial Outcomes & Findings for mActive: A Blinded, Randomized mHealth Activity Trial (NCT NCT01917812)
NCT ID: NCT01917812
Last Updated: 2017-03-23
Results Overview
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.
COMPLETED
NA
48 participants
Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)
2017-03-23
Participant Flow
We enrolled outpatients at an academic cardiovascular prevention center (Johns Hopkins Ciccarone Center) in Baltimore, Maryland, USA from January 17 to May 20, 2014.
Participant milestones
| Measure |
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.
Unblinded Digital Activity Tracker
Smart Text Messaging
|
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.
Blinded Digital Activity Tracker
|
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.
Unblinded Digital Activity Tracker
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
mActive: A Blinded, Randomized mHealth Activity Trial
Baseline characteristics by cohort
| Measure |
Blinded Digital Activity Tracker
n=16 Participants
Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.
Blinded Digital Activity Tracker
|
Unblinded Digital Activity Tracker / No Smart Text Messaging
n=16 Participants
Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.
Unblinded Digital Activity Tracker
|
Unblinded Digital Activity Tracker / Smart Text Messaging
n=16 Participants
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.
Unblinded Digital Activity Tracker
Smart Text Messaging
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 7 • n=5 Participants
|
58 years
STANDARD_DEVIATION 8 • n=7 Participants
|
55 years
STANDARD_DEVIATION 8 • n=5 Participants
|
58 years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
48 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Blinded Digital Activity Tracker
n=16 Participants
|
Unblinded Digital Activity Tracker
n=32 Participants
|
Unblinded Digital Activity Tracker / Smart Text Messaging
|
|---|---|---|---|
|
Mean Daily Step Count
|
-616 steps per day
Standard Deviation 2385
|
408 steps per day
Standard Deviation 2701
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Blinded Digital Activity Tracker
n=16 Participants
|
Unblinded Digital Activity Tracker
n=16 Participants
|
Unblinded Digital Activity Tracker / Smart Text Messaging
n=16 Participants
|
|---|---|---|---|
|
Mean Daily Step Count
|
-1042 steps per day
Standard Deviation 2202
|
-200 steps per day
Standard Deviation 1653
|
2334 steps per day
Standard Deviation 1714
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Blinded Digital Activity Tracker
n=16 Participants
|
Unblinded Digital Activity Tracker
n=32 Participants
|
Unblinded Digital Activity Tracker / Smart Text Messaging
|
|---|---|---|---|
|
Mean Daily Activity Time
|
-6 minutes per day
Standard Deviation 26
|
2 minutes per day
Standard Deviation 27
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Blinded Digital Activity Tracker
n=16 Participants
|
Unblinded Digital Activity Tracker
n=32 Participants
|
Unblinded Digital Activity Tracker / Smart Text Messaging
|
|---|---|---|---|
|
Mean Daily Aerobic Activity Time
|
-11 minutes per day
Standard Deviation 14
|
-3 minutes per day
Standard Deviation 12
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Blinded Digital Activity Tracker
n=16 Participants
|
Unblinded Digital Activity Tracker
n=16 Participants
|
Unblinded Digital Activity Tracker / Smart Text Messaging
n=16 Participants
|
|---|---|---|---|
|
Mean Daily Activity Time
|
-8 minutes per day
Standard Deviation 23
|
0 minutes per day
Standard Deviation 17
|
21 minutes per day
Standard Deviation 20
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Blinded Digital Activity Tracker
n=16 Participants
|
Unblinded Digital Activity Tracker
n=16 Participants
|
Unblinded Digital Activity Tracker / Smart Text Messaging
n=16 Participants
|
|---|---|---|---|
|
Mean Daily Aerobic Activity Time
|
-3 minutes per day
Standard Deviation 10
|
-1 minutes per day
Standard Deviation 8
|
13 minutes per day
Standard Deviation 11
|
Adverse Events
Blinded Digital Activity Tracker
Unblinded Digital Activity Tracker / No Smart Text Messaging
Unblinded Digital Activity Tracker / Smart Text Messaging
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Seth S Martin
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place