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Increasing Steps Per Day in Rural Veterans

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VA MapTrek
Fitbit Only
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Veterans

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VA MapTrek

Fitbit Only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total Number of Steps per Day
The Fitbit will provide the total number of steps that each Veteran has taken per day.

Secondary Outcome Measures

Challenge Effectiveness
Number of challenges participated in and number of steps taken as a result of challenges will be assessed.

Full Information

First Posted
April 25, 2019
Last Updated
April 26, 2021
Sponsor
University of Iowa
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT03930238
Brief Title
Increasing Steps Per Day in Rural Veterans
Official Title
VA MapTrek, an M-Health Intervention to Increase Steps Per Day in Rural Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
May 10, 2020 (Actual)
Study Completion Date
May 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Veterans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VA MapTrek
Arm Type
Experimental
Arm Description
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.
Arm Title
Fitbit Only
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
VA MapTrek
Intervention Description
The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
Intervention Type
Behavioral
Intervention Name(s)
Fitbit Only
Intervention Description
Fitbit Only
Primary Outcome Measure Information:
Title
Total Number of Steps per Day
Description
The Fitbit will provide the total number of steps that each Veteran has taken per day.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Challenge Effectiveness
Description
Number of challenges participated in and number of steps taken as a result of challenges will be assessed.
Time Frame
9 weeks
Other Pre-specified Outcome Measures:
Title
VA MapTrek Future Development Survey
Description
Veterans will report areas of development within VA MapTrek to improve its future efficacy.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip M Polgreen, MD, MPH
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Health Care System
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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