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Increasing Steps Per Day in Rural Veterans

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ClinicalTrials.gov Identifier: NCT03930238
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
US Department of Veterans Affairs
Information provided by (Responsible Party):
Philip Polgreen, University of Iowa

Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date May 6, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03930238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
Challenge Effectiveness [ Time Frame: 9 weeks ]
Number of challenges participated in and number of steps taken as a result of challenges will be assessed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 25, 2019)
VA MapTrek Future Development Survey [ Time Frame: 9 weeks ]
Veterans will report areas of development within VA MapTrek to improve its future efficacy.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Increasing Steps Per Day in Rural Veterans
Official Title  ICMJE VA MapTrek, an M-Health Intervention to Increase Steps Per Day in Rural Veterans
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Behavioral: VA MapTrek
    The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
  • Behavioral: Fitbit Only
    Fitbit Only
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: VA MapTrek
  • 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.
    Intervention: Behavioral: Fitbit Only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philip M Polgreen, MD, MPH (319) 384-6194 philip-polgreen@uiowa.edu
Contact: Shelby L Francis, PhD (319) 678-8037 shelby-francis@uiowa.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930238
Other Study ID Numbers  ICMJE 201901762
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Philip Polgreen, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE US Department of Veterans Affairs
Investigators  ICMJE Not Provided
PRS Account University of Iowa
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP