Trial Outcomes & Findings for Increasing Steps Per Day in Rural Veterans (NCT NCT03930238)
NCT ID: NCT03930238
Last Updated: 2024-10-17
Results Overview
The Fitbit will provide the total number of steps that each Veteran has taken per day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
276 participants
Primary outcome timeframe
9 weeks
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
VA MapTrek
Veterans in the intervention group receive a Fitbit and access to VA MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required to enroll). Each week, Veterans are assigned to a virtual walking route. Each day, they receive a text message with a link to the current route. The link will take them to a map where they can see their progress and the progress of others. A leaderboard provides information on how many steps each participant has taken. Throughout each race, participants will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map.
VA MapTrek: The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
|
Fitbit Only
Veterans randomized to the control group will receive a Fitbit only. This will allow us to determine if changes in physical activity are due to VA MapTrek or simply by giving the Veterans a Fitbit.
Fitbit Only: Fitbit Only
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
123
|
|
Overall Study
Collected Any Fitbit Data During Baseline Period
|
152
|
114
|
|
Overall Study
COMPLETED
|
149
|
102
|
|
Overall Study
NOT COMPLETED
|
4
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1 Veteran was older than 89 years of age, so their exact age could not be specified. 1 Veteran's age was missing.
Baseline characteristics by cohort
| Measure |
VA MapTrek
n=153 Participants
Veterans in the intervention group receive a Fitbit and access to VA MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required to enroll). Each week, Veterans are assigned to a virtual walking route. Each day, they receive a text message with a link to the current route. The link will take them to a map where they can see their progress and the progress of others. A leaderboard provides information on how many steps each participant has taken. Throughout each race, participants will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map.
VA MapTrek: The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
|
Fitbit Only
n=123 Participants
Veterans randomized to the control group will receive a Fitbit only. This will allow us to determine if changes in physical activity are due to VA MapTrek or simply by giving the Veterans a Fitbit.
Fitbit Only: Fitbit Only
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 Years
STANDARD_DEVIATION 12.7 • n=151 Participants • 1 Veteran was older than 89 years of age, so their exact age could not be specified. 1 Veteran's age was missing.
|
61.9 Years
STANDARD_DEVIATION 13.0 • n=123 Participants • 1 Veteran was older than 89 years of age, so their exact age could not be specified. 1 Veteran's age was missing.
|
60.9 Years
STANDARD_DEVIATION 12.8 • n=274 Participants • 1 Veteran was older than 89 years of age, so their exact age could not be specified. 1 Veteran's age was missing.
|
|
Sex: Female, Male
Female
|
23 Participants
n=153 Participants
|
12 Participants
n=123 Participants
|
35 Participants
n=276 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=153 Participants
|
111 Participants
n=123 Participants
|
241 Participants
n=276 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=153 Participants
|
5 Participants
n=123 Participants
|
11 Participants
n=276 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=153 Participants
|
118 Participants
n=123 Participants
|
265 Participants
n=276 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=153 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=276 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=153 Participants
|
1 Participants
n=123 Participants
|
2 Participants
n=276 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=153 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=276 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=153 Participants
|
0 Participants
n=123 Participants
|
2 Participants
n=276 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=153 Participants
|
4 Participants
n=123 Participants
|
14 Participants
n=276 Participants
|
|
Race (NIH/OMB)
White
|
136 Participants
n=153 Participants
|
114 Participants
n=123 Participants
|
250 Participants
n=276 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=153 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=276 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=153 Participants
|
4 Participants
n=123 Participants
|
8 Participants
n=276 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=153 Participants
|
123 participants
n=123 Participants
|
276 participants
n=276 Participants
|
|
Lives in Urban Area
|
77 Participants
n=153 Participants • Address could not be determined for 1 Veteran in the Fitbit Only Group.
|
55 Participants
n=122 Participants • Address could not be determined for 1 Veteran in the Fitbit Only Group.
|
132 Participants
n=275 Participants • Address could not be determined for 1 Veteran in the Fitbit Only Group.
|
|
Marital Status
Currently Married
|
113 Participants
n=153 Participants
|
83 Participants
n=123 Participants
|
196 Participants
n=276 Participants
|
|
Marital Status
Previously Married
|
31 Participants
n=153 Participants
|
29 Participants
n=123 Participants
|
60 Participants
n=276 Participants
|
|
Marital Status
Never Married
|
5 Participants
n=153 Participants
|
4 Participants
n=123 Participants
|
9 Participants
n=276 Participants
|
|
Marital Status
Other
|
4 Participants
n=153 Participants
|
7 Participants
n=123 Participants
|
11 Participants
n=276 Participants
|
|
Body Mass Index
|
32.9 kg/m^2
STANDARD_DEVIATION 5.6 • n=152 Participants • Missing participants did not have BMI values present in their medical record.
|
33.7 kg/m^2
STANDARD_DEVIATION 5.8 • n=121 Participants • Missing participants did not have BMI values present in their medical record.
|
33.2 kg/m^2
STANDARD_DEVIATION 5.7 • n=273 Participants • Missing participants did not have BMI values present in their medical record.
|
|
Systolic Blood Pressure
|
130.1 mmHg
STANDARD_DEVIATION 14.6 • n=152 Participants • Missing values were due to missing systolic blood pressures in the medical record.
|
130.0 mmHg
STANDARD_DEVIATION 79.1 • n=121 Participants • Missing values were due to missing systolic blood pressures in the medical record.
|
130.0 mmHg
STANDARD_DEVIATION 14.6 • n=273 Participants • Missing values were due to missing systolic blood pressures in the medical record.
|
|
Diastolic Blood Pressure
|
79.1 mmHg
STANDARD_DEVIATION 8.2 • n=152 Participants • Missing values due to missing diastolic blood pressure values in the medical record.
|
79.1 mmHg
STANDARD_DEVIATION 9.3 • n=121 Participants • Missing values due to missing diastolic blood pressure values in the medical record.
|
79.1 mmHg
STANDARD_DEVIATION 8.7 • n=273 Participants • Missing values due to missing diastolic blood pressure values in the medical record.
|
|
Number of Medications
|
9.6 Medications
STANDARD_DEVIATION 6.9 • n=153 Participants
|
9.4 Medications
STANDARD_DEVIATION 5.7 • n=123 Participants
|
9.5 Medications
STANDARD_DEVIATION 6.4 • n=276 Participants
|
|
Number of Comorbidities
|
9.7 Comorbidities
STANDARD_DEVIATION 5.9 • n=153 Participants
|
10.3 Comorbidities
STANDARD_DEVIATION 5.4 • n=123 Participants
|
10.0 Comorbidities
STANDARD_DEVIATION 5.7 • n=276 Participants
|
|
Days with Step Data
|
6.9 Days
STANDARD_DEVIATION 5.0 • n=153 Participants
|
4.6 Days
STANDARD_DEVIATION 1.8 • n=123 Participants
|
5.9 Days
STANDARD_DEVIATION 4.2 • n=276 Participants
|
|
Number of Steps per Day
|
7023 Steps
STANDARD_DEVIATION 4080 • n=147 Participants • Missing values due to Veterans not syncing Fitbit steps during baseline period.
|
6754 Steps
STANDARD_DEVIATION 3545 • n=108 Participants • Missing values due to Veterans not syncing Fitbit steps during baseline period.
|
6909 Steps
STANDARD_DEVIATION 3857 • n=255 Participants • Missing values due to Veterans not syncing Fitbit steps during baseline period.
|
PRIMARY outcome
Timeframe: 9 weeksThe Fitbit will provide the total number of steps that each Veteran has taken per day.
Outcome measures
| Measure |
VA MapTrek
n=149 Participants
Veterans in the intervention group receive a Fitbit and access to VA MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required to enroll). Each week, Veterans are assigned to a virtual walking route. Each day, they receive a text message with a link to the current route. The link will take them to a map where they can see their progress and the progress of others. A leaderboard provides information on how many steps each participant has taken. Throughout each race, participants will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map.
VA MapTrek: The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
|
Fitbit Only
n=102 Participants
Veterans randomized to the control group will receive a Fitbit only. This will allow us to determine if changes in physical activity are due to VA MapTrek or simply by giving the Veterans a Fitbit.
Fitbit Only: Fitbit Only
|
|---|---|---|
|
Total Number of Steps Per Day
|
8756 Steps per day
Standard Deviation 6251
|
7334 Steps per day
Standard Deviation 4596
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Percentage of challenges met.
Percentage of challenges that were met will be assessed.
Outcome measures
| Measure |
VA MapTrek
n=3842 Challenges
Veterans in the intervention group receive a Fitbit and access to VA MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required to enroll). Each week, Veterans are assigned to a virtual walking route. Each day, they receive a text message with a link to the current route. The link will take them to a map where they can see their progress and the progress of others. A leaderboard provides information on how many steps each participant has taken. Throughout each race, participants will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map.
VA MapTrek: The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
|
Fitbit Only
Veterans randomized to the control group will receive a Fitbit only. This will allow us to determine if changes in physical activity are due to VA MapTrek or simply by giving the Veterans a Fitbit.
Fitbit Only: Fitbit Only
|
|---|---|---|
|
Challenge Effectiveness
|
2008 Percentage of Challenges Met
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 weeksVeterans will respond to an exit survey about their experiences with the study.
Outcome measures
| Measure |
VA MapTrek
n=153 Participants
Veterans in the intervention group receive a Fitbit and access to VA MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required to enroll). Each week, Veterans are assigned to a virtual walking route. Each day, they receive a text message with a link to the current route. The link will take them to a map where they can see their progress and the progress of others. A leaderboard provides information on how many steps each participant has taken. Throughout each race, participants will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map.
VA MapTrek: The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
|
Fitbit Only
n=123 Participants
Veterans randomized to the control group will receive a Fitbit only. This will allow us to determine if changes in physical activity are due to VA MapTrek or simply by giving the Veterans a Fitbit.
Fitbit Only: Fitbit Only
|
|---|---|---|
|
Completion of an Exit Survey
|
100 Participants
|
55 Participants
|
Adverse Events
VA MapTrek
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fitbit Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place