- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03930238
Increasing Steps Per Day in Rural Veterans
VA MapTrek, an M-Health Intervention to Increase Steps Per Day in Rural Veterans
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52246
- VA Health Care System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
|
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Number of Steps Per Day
Time Frame: 9 weeks
|
The Fitbit will provide the total number of steps that each Veteran has taken per day.
|
9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Challenge Effectiveness
Time Frame: 9 weeks
|
Percentage of challenges that were met will be assessed.
|
9 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of an Exit Survey
Time Frame: 9 weeks
|
Veterans will respond to an exit survey about their experiences with the study.
|
9 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip M Polgreen, MD, MPH, University of Iowa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201901762
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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