Clinical trial NCT03930238: Increasing Steps Per Day in Rural Veterans
Official title: VA MapTrek, an M-Health Intervention to Increase Steps Per Day in Rural Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Veterans
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2019-04-29
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Number of Steps Per Day
timeFrame: 9 weeks
Secondary outcomes:
measure: Challenge Effectiveness
timeFrame: 9 weeks
Other outcomes:
measure: Completion of an Exit Survey
timeFrame: 9 weeks
Locations:
city: Iowa City
country: United States
facility: VA Health Care System
state: Iowa
Study officials:
affiliation: University of Iowa
name: Philip M Polgreen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: