ObesityNCT03930238
Increasing Steps Per Day in Rural Veterans
A study testing VA MapTrek and Fitbit Only in people with Obesity and Overweight, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- VA MapTrek and Fitbit Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 10 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- Pregnancy
- Active mental health conditions that prevent them from providing consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VA MapTrek, an M-Health Intervention to Increase Steps Per Day in Rural Veterans
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.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- VA MapTrek, Fitbit Only
- Keywords
- Veterans
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VA MapTrekBehavioural
The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
Fitbit OnlyBehavioural
Fitbit Only
| Study group | Role | What they receive |
|---|---|---|
| VA MapTrek | Experimental | 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. Receives: Behavioral: VA 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 VA MapTrek or simply by giving the Veterans a Fitbit. Receives: Behavioral: Fitbit Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Steps Per Day
The Fitbit will provide the total number of steps that each Veteran has taken per day.
Measured: 9 weeks
Secondary outcomes (1)
Challenge Effectiveness
Percentage of challenges that were met will be assessed.
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 posted29 Apr 2019
- Study start15 May 2019
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 276 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
- Investigators
- Philip M Polgreen, MD, MPH, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930238
- Sponsor's protocol ID
- 201901762
- Status last verified
- Oct 2024
- First submitted
- 25 Apr 2019
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VA MapTrek, an M-Health Intervention to Increase Steps Per Day in Rural Veterans
- ClinicalTrials.gov ID
- NCT03930238
- Acronym / sponsor ID
- 201901762
- Conditions
- Obesity, Overweight
- Keywords
- Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 15 May 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA MapTrek | Experimental | Behavioral: VA MapTrekVeterans 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. |
| Fitbit Only | Active comparator | Behavioral: Fitbit OnlyVeterans 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Active mental health conditions that prevent them from providing 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 |
|---|---|---|
| VA MapTrekThe objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more. | Behavioural | VA MapTrek |
| Fitbit OnlyFitbit Only | Behavioural | Fitbit Only |
Primary outcome
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.
1 secondary outcome
Challenge Effectiveness
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Philip M Polgreen, MD, MPH principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VA MapTrek and Fitbit Only in people with Obesity and Overweight, 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 5 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 17 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Number of Steps Per Day (time frame: 9 weeks). 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 17 Oct 2024.