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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VA MapTrek | Behavioral | The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Steps Per Day | The Fitbit will provide the total number of steps that each Veteran has taken per day. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Challenge Effectiveness | Percentage of challenges that were met will be assessed. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of an Exit Survey | Veterans will respond to an exit survey about their experiences with the study. | 9 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip M Polgreen, MD, MPH | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Health Care System | Iowa City | Iowa | 52246 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All Veterans enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 Veteran was older than 89 years of age, so their exact age could not be specified. 1 Veteran's age was missing. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Steps Per Day | The Fitbit will provide the total number of steps that each Veteran has taken per day. | Posted | Mean | Standard Deviation | Steps per day | 9 weeks |
|
9 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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We do not know if Veterans wore the Fitbit or not. Days with partial wear will undercount total number of steps. However, this should be balanced between groups. Additionally, the groups were not equal because we had to stop enrollment early due to the COVID-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacob Simmering | University of Iowa | 319-384-1107 | jacob-simmering@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Feb 15, 2019 | May 22, 2024 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2024 | Sep 26, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Fitbit Only | Behavioral | Fitbit Only |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lives in Urban Area | Address could not be determined for 1 Veteran in the Fitbit Only Group. | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Body Mass Index | Missing participants did not have BMI values present in their medical record. | Mean | Standard Deviation | kg/m^2 |
|
| Systolic Blood Pressure | Missing values were due to missing systolic blood pressures in the medical record. | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Missing values due to missing diastolic blood pressure values in the medical record. | Mean | Standard Deviation | mmHg |
|
| Number of Medications | Mean | Standard Deviation | Medications |
|
| Number of Comorbidities | Mean | Standard Deviation | Comorbidities |
|
| Days with Step Data | Mean | Standard Deviation | Days |
|
| Number of Steps per Day | Missing values due to Veterans not syncing Fitbit steps during baseline period. | Mean | Standard Deviation | Steps |
|
| OG001 | 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 |
|
|
|
| Secondary | Challenge Effectiveness | Percentage of challenges that were met will be assessed. | Percentage of challenges met. | Posted | Number | Percentage of Challenges Met | 9 weeks | Challenges | Challenges |
|
|
|
|
| Other Pre-specified | Completion of an Exit Survey | Veterans will respond to an exit survey about their experiences with the study. | Posted | Count of Participants | Participants | 9 weeks |
|
|
|
| 0 |
| 153 |
| 0 |
| 153 |
| 0 |
| 153 |
| EG001 | 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 | 0 | 123 | 0 | 123 | 0 | 123 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Never Married |
|
| Other |
|