VeteransNCT03720054
An M-Health Intervention in Rural Veterans
A study testing MapTrek and Fitbit in people with Veterans and Obesity, run by University of Iowa at 1 site in United States.
Trial summary
MapTrek is a mobile-phone-based web app 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Veterans, Obesity, Overweight
- What is being tested?
- MapTrek and Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Be comfortable speaking and reading in English
- Have a BMI of at least 25
- Have a smartphone with texting and internet capabilities
- Be willing to download the Fitbit app onto their phone
- Must be a VA patient
Who cannot join
- Pregnancy
- Active mental health conditions that prevent them from providing own consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An M-Health Intervention to Increase Activity Levels in Rural Veterans
MapTrek is a mobile-phone-based web app 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 own updated progress overlaid on Google Maps, with Google Maps features (e.g. zooming, street view, etc.) available. The objective is to report activity levels in the virtual environment to veterans, thereby encouraging them first, to walk more every day, and second, to maintain these new increased levels of physical activity.
Read the detailed description
All consented participants will be provided with a Fitbit and instructed to wear it all day for the next 9 weeks. This process should take approximately 15 to 45 minutes, depending on group assignment.
This, plus an exit survey and 3-month follow-up survey(given via text message or phone call, whichever the participant prefers), will be the extent of the participation in the control group.
Members of the intervention group will be instructed on how to use MapTrek, the virtual walking race. 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 race 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 and end on Sunday. Depending on each veteran's performance each week, group assignment may change. Participants will compete in 8 week-long races over the course of the study.
For each race, the participants will receive 2-4 text messages each day including a daily status report and a link to the current race. The participants will also periodically receive challenge text messages. If participants accept a challenge and meet it, they will be awarded bonus steps to help move them along the route in the race.
To win a race, participants must be the first to cross the finish line on the route for the week. There is a leaderboard within MapTrek that helps participants determine their standings within each race. Participants are allowed to choose a screen name to show on the leaderboard so that they may remain anonymous if desired.
For all participants, the investigators will collect first and last name and the last 4 digits of the participant's Social Security Number for consent documentation purposes and to look the person up in the VA medical record (CPRS). The following information will be collected from CPRS at baseline: age, sex, race, marital status, height, weight, body mass index, blood pressure, zip code, and current medications. Height, weight, body mass index, and blood pressure values will be collected again at the 9 week and 3 month follow ups. The following information will be collected from the MOVE! participation records at baseline: date enrolled in MOVE! program, number of MOVE! classes attended, weight when enrolled in the MOVE! program.
At the end of the 9 weeks of participation, participants will be contacted to complete an exit survey either via text message or phone call, whichever was stated as the preferred method at enrollment. This will take approximately 10 minutes to complete.
3 months after the study ends, the participants will be contacted to complete a 3-month follow-up survey either via text message or phone call, whichever was stated as the preferred method at enrollment. This will take approximately 10 minutes to complete.
Participants who do not respond will be contacted via text message and phone call up to 3 times. If participants still cannot be reached they will be considered lost to followup.
- Conditions
- Veterans, Obesity, Overweight
- Being tested
- MapTrek, Fitbit
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MapTrekBehavioural
Our objective is to report activity levels in our virtual environment to veterans, thereby encouraging them first, to walk more every day, and second, to maintain these new increased levels of physical activity. MapTrek will also motivate veterans to accumulate less sedentary time.
FitbitBehavioural
Fitbit Only
| Study group | Role | What they receive |
|---|---|---|
| MapTrek | Experimental | Veterans in the intervention group receive a Fitbit and MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required prior to enrollment). 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. MapTrek also supports Street View on Google Maps, so veterans can explore what they would see if they were in that location. Throughout each race, patients will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map. Receives: Behavioral: MapTrek |
| Fitbit Only | Active comparator | 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 MapTrek or simply by giving the veterans a Fitbit. Receives: Behavioral: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Ability to Participate
Ability (smartphone ownership, texting skill) to participate will be assessed via self-report from the participant.
Measured: 9 weeks
Fitbit Usage
Amount of time (number of days, hours per day) spent wearing the Fitbit will be assessed.
Measured: 9 weeks
Challenge Usage
Number of challenges participated in will be assessed.
Measured: 9 weeks
Secondary outcomes (1)
Total Number of Steps per Day
The Fitbit will provide the total number of steps that each veterans has taken per day.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start26 Feb 2018
- Primary completion29 Oct 2018
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VeteransStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Philip Polgreen, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720054
- Sponsor's protocol ID
- 201710866
- Status last verified
- Apr 2019
- First submitted
- 15 Oct 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An M-Health Intervention to Increase Activity Levels in Rural Veterans
- ClinicalTrials.gov ID
- NCT03720054
- Acronym / sponsor ID
- 201710866
- Conditions
- Veterans, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MapTrek is a mobile-phone-based web app 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 own updated progress overlaid on Google Maps, with Google Maps features (e.g. zooming, street view, etc.) available. The objective is to report activity levels in the virtual environment to veterans, thereby encouraging them first, to walk more every day, and second, to maintain these new increased levels of physical activity.
Detailed description
All consented participants will be provided with a Fitbit and instructed to wear it all day for the next 9 weeks. This process should take approximately 15 to 45 minutes, depending on group assignment.
This, plus an exit survey and 3-month follow-up survey(given via text message or phone call, whichever the participant prefers), will be the extent of the participation in the control group.
Members of the intervention group will be instructed on how to use MapTrek, the virtual walking race. 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 race 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 and end on Sunday. Depending on each veteran's performance each week, group assignment may change. Participants will compete in 8 week-long races over the course of the study.
For each race, the participants will receive 2-4 text messages each day including a daily status report and a link to the current race. The participants will also periodically receive challenge text messages. If participants accept a challenge and meet it, they will be awarded bonus steps to help move them along the route in the race.
To win a race, participants must be the first to cross the finish line on the route for the week. There is a leaderboard within MapTrek that helps participants determine their standings within each race. Participants are allowed to choose a screen name to show on the leaderboard so that they may remain anonymous if desired.
For all participants, the investigators will collect first and last name and the last 4 digits of the participant's Social Security Number for consent documentation purposes and to look the person up in the VA medical record (CPRS). The following information will be collected from CPRS at baseline: age, sex, race, marital status, height, weight, body mass index, blood pressure, zip code, and current medications. Height, weight, body mass index, and blood pressure values will be collected again at the 9 week and 3 month follow ups. The following information will be collected from the MOVE! participation records at baseline: date enrolled in MOVE! program, number of MOVE! classes attended, weight when enrolled in the MOVE! program.
At the end of the 9 weeks of participation, participants will be contacted to complete an exit survey either via text message or phone call, whichever was stated as the preferred method at enrollment. This will take approximately 10 minutes to complete.
3 months after the study ends, the participants will be contacted to complete a 3-month follow-up survey either via text message or phone call, whichever was stated as the preferred method at enrollment. This will take approximately 10 minutes to complete.
Participants who do not respond will be contacted via text message and phone call up to 3 times. If participants still cannot be reached they will be considered lost to followup.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MapTrek | Experimental | Behavioral: MapTrekVeterans in the intervention group receive a Fitbit and MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required prior to enrollment). 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. MapTrek also supports Street View on Google Maps, so veterans can explore what they would see if they were in that location. Throughout each race, patients will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map. |
| Fitbit Only | Active comparator | Behavioral: FitbitVeterans randomized to the control group will receive a Fitbit only. This will allow us to determine if changes in physical activity are due to MapTrek or simply by giving the veterans a Fitbit. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years old
- Be comfortable speaking and reading in English
- Have a BMI of at least 25
- Have a smartphone with texting and internet capabilities
- Be willing to download the Fitbit app onto their phone
Key exclusion criteria (2 listed)
- Pregnancy
- Active mental health conditions that prevent them from providing own consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MapTrekOur objective is to report activity levels in our virtual environment to veterans, thereby encouraging them first, to walk more every day, and second, to maintain these new increased levels of physical activity. MapTrek will also motivate veterans to accumulate less sedentary time. | Behavioural | MapTrek |
| FitbitFitbit Only | Behavioural | Fitbit Only |
Primary outcome
Self-Reported Ability to Participate
Time frame: 9 weeks
Ability (smartphone ownership, texting skill) to participate will be assessed via self-report from the participant.
Fitbit Usage
Time frame: 9 weeks
Amount of time (number of days, hours per day) spent wearing the Fitbit will be assessed.
Challenge Usage
Time frame: 9 weeks
Number of challenges participated in will be assessed.
1 secondary outcome
Total Number of Steps per Day
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MapTrek and Fitbit in people with Veterans and Obesity, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Ability to Participate (time frame: 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.