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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

Increasing Steps Per Day in Rural Veterans

Clinicaltrials.gov identifier NCT03930238

Recruitment Status Enrolling by invitation

First Posted April 29, 2019

Last update posted October 2, 2019

Study Description

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.

  • Condition or Disease:Obesity
    Overweight
  • Intervention/Treatment: Behavioral: VA MapTrek
    Behavioral: Fitbit Only
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 300 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: VA MapTrek, an M-Health Intervention to Increase Steps Per Day in Rural Veterans
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: February 2020
  • Estimated Study Completion Date: August 2020
Arms and interventions
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.
Behavioral: VA MapTrek
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.
Behavioral: Fitbit Only
Fitbit Only
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. Challenge Effectiveness [ Time Frame: 9 weeks ]
    Number of challenges participated in and number of steps taken as a result of challenges will be assessed.
  • Other Outcome Measures: 1. VA MapTrek Future Development Survey [ Time Frame: 9 weeks ]
    Veterans will report areas of development within VA MapTrek to improve its future efficacy.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 100 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts
Locations

United States, Iowa
VA Health Care System
Iowa City

Sponsors and Collaborators

University of Iowa

US Department of Veterans Affairs

More Information
  • Responsible Party: University of Iowa
  • ClinicalTrials.gov Identifier: NCT03930238 History of Changes
  • Other Study ID Numbers: 201901762
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: October 2, 2019
  • Last Verified: September 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Iowa: Veterans
  • Additional relevant MeSH terms: Overweight