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Increasing Steps Per Day in Rural Veterans

VA MapTrek, an M-Health Intervention to Increase Steps Per Day in Rural Veterans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03930238
Enrollment
276
Registered
2019-04-29
Start date
2019-05-15
Completion date
2020-05-10
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Veterans

Brief summary

VA MapTrek is a mobile-phone-based web application that allows participants to take a virtual walk in interesting locations around the world while tracking their progress against the progress of other veterans on an interactive map. Steps are counted using a commercially-available triaxial accelerometer (e.g., Fitbit), and users see their progress overlaid on Google Maps. The objective of this study is to report activity levels to veterans, thereby encouraging them to walk more. Once participants know how to text and use Google maps, no additional training is needed. VA MapTrek does not require a special app, so there are no logins or passwords to remember. Simply registering one's Fitbit and mobile phone at an initial enrollment meeting suffices.

Detailed description

All consented participants will be provided with a Fitbit and instructed to wear it all day, every day for the next 9 weeks (The first few participants may require an additional week or two of wear as we will not begin the first MapTrek race until we have at least 5 participants enrolled in the study. They will be told this upon enrollment.). The enrollment process is expected to take anywhere from 15 to 45 minutes, depending on group assignment and participant familiarity with using Fitbits. This, plus an exit survey (given via text message or phone, whichever the participant prefers), will be the extent of participation for the control group. Members of the intervention group will be instructed on how to use MapTrek, the virtual walking race, and will also be given an instruction packet to refer to later. Data collected during the first week from the Fitbit will be used to compute baseline activity level. This baseline data will be used to place participants into an appropriate initial race group. Participants are placed into groups with other individuals who are active at a similar level, so that groups will be competitive. Each virtual walking race will begin on Monday morning and end on Saturday night. Results of each race will be announced on Sundays. Depending on their performance each week, group assignment may change. Participants will compete in 8 week-long races over the course of the study. Participants will receive 2-4 text messages per day including a daily status report and a link to view the race. They will also periodically receive challenge messages. If a participant completes a challenge, they will be awarded bonus steps to help move them along the route quicker. To win a race, a participant must be furthest along on the route at 11:59 pm on Saturday. There is a leaderboard within MapTrek that helps participants determine their standing within each race. Participants are allowed to choose the screen name displayed on the leaderboard so that they may remain anonymous if desired. At baseline, the following data will be collected about all participants: first and last name, last 4 of social security number (for consent documentation and to look up records in CPRS), age, sex, race, ethnicity, marital status, height, weight, body mass index, blood pressure, zip code, current medications, and comorbidities. At the end of the study (9 weeks), the following data will be collected about all participants: height, weight, body mass index, blood pressure, current medications, and comorbidities. At the end of the study (9 weeks), participants will be contacted via text message or phone call (based on their preference at baseline) to complete an exit survey. This survey will take approximately 10 minutes to complete. All participants will be contacted up to 3 times to complete the exit survey. If they cannot be reached, they will be considered lost to follow up.

Interventions

BEHAVIORALVA MapTrek

The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.

BEHAVIORALFitbit Only

Fitbit Only

Sponsors

US Department of Veterans Affairs
CollaboratorFED
University of Iowa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Comfortable speaking and reading in English * BMI greater than or equal to 25 * Have a smart phone with texting and internet capabilities * Willing to download the Fitbit app on their phone * Must be a VA patient

Exclusion criteria

* Pregnancy * Active mental health conditions that prevent them from providing consent

Design outcomes

Primary

MeasureTime frameDescription
Total Number of Steps Per Day9 weeksThe Fitbit will provide the total number of steps that each Veteran has taken per day.

Secondary

MeasureTime frameDescription
Challenge Effectiveness9 weeksPercentage of challenges that were met will be assessed.

Other

MeasureTime frameDescription
Completion of an Exit Survey9 weeksVeterans will respond to an exit survey about their experiences with the study.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
153
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
123
Total276

Baseline characteristics

CharacteristicVA MapTrekFitbit OnlyTotal
Age, Continuous59.9 Years
STANDARD_DEVIATION 12.7
61.9 Years
STANDARD_DEVIATION 13
60.9 Years
STANDARD_DEVIATION 12.8
Body Mass Index32.9 kg/m^2
STANDARD_DEVIATION 5.6
33.7 kg/m^2
STANDARD_DEVIATION 5.8
33.2 kg/m^2
STANDARD_DEVIATION 5.7
Days with Step Data6.9 Days
STANDARD_DEVIATION 5
4.6 Days
STANDARD_DEVIATION 1.8
5.9 Days
STANDARD_DEVIATION 4.2
Diastolic Blood Pressure79.1 mmHg
STANDARD_DEVIATION 8.2
79.1 mmHg
STANDARD_DEVIATION 9.3
79.1 mmHg
STANDARD_DEVIATION 8.7
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants5 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
147 Participants118 Participants265 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Lives in Urban Area77 Participants55 Participants132 Participants
Marital Status
Currently Married
113 Participants83 Participants196 Participants
Marital Status
Never Married
5 Participants4 Participants9 Participants
Marital Status
Other
4 Participants7 Participants11 Participants
Marital Status
Previously Married
31 Participants29 Participants60 Participants
Number of Comorbidities9.7 Comorbidities
STANDARD_DEVIATION 5.9
10.3 Comorbidities
STANDARD_DEVIATION 5.4
10.0 Comorbidities
STANDARD_DEVIATION 5.7
Number of Medications9.6 Medications
STANDARD_DEVIATION 6.9
9.4 Medications
STANDARD_DEVIATION 5.7
9.5 Medications
STANDARD_DEVIATION 6.4
Number of Steps per Day7023 Steps
STANDARD_DEVIATION 4080
6754 Steps
STANDARD_DEVIATION 3545
6909 Steps
STANDARD_DEVIATION 3857
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants4 Participants14 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants4 Participants8 Participants
Race (NIH/OMB)
White
136 Participants114 Participants250 Participants
Region of Enrollment
United States
153 participants123 participants276 participants
Sex: Female, Male
Female
23 Participants12 Participants35 Participants
Sex: Female, Male
Male
130 Participants111 Participants241 Participants
Systolic Blood Pressure130.1 mmHg
STANDARD_DEVIATION 14.6
130.0 mmHg
STANDARD_DEVIATION 79.1
130.0 mmHg
STANDARD_DEVIATION 14.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1530 / 123
other
Total, other adverse events
0 / 1530 / 123
serious
Total, serious adverse events
0 / 1530 / 123

Outcome results

Primary

Total Number of Steps Per Day

The Fitbit will provide the total number of steps that each Veteran has taken per day.

Time frame: 9 weeks

ArmMeasureValue (MEAN)Dispersion
VA MapTrekTotal Number of Steps Per Day8756 Steps per dayStandard Deviation 6251
Fitbit OnlyTotal Number of Steps Per Day7334 Steps per dayStandard Deviation 4596
Bayesian linear mixed effects regression
Secondary

Challenge Effectiveness

Percentage of challenges that were met will be assessed.

Time frame: 9 weeks

Population: Percentage of challenges met.

ArmMeasureValue (NUMBER)
VA MapTrekChallenge Effectiveness2008 Percentage of Challenges Met
Other Pre-specified

Completion of an Exit Survey

Veterans will respond to an exit survey about their experiences with the study.

Time frame: 9 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
VA MapTrekCompletion of an Exit Survey100 Participants
Fitbit OnlyCompletion of an Exit Survey55 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026