Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 5441 for:    veterans

Increasing Steps Per Day in Rural Veterans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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 Intervention/treatment Phase
Obesity Overweight Behavioral: VA MapTrek Behavioral: Fitbit Only Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930238


Contacts
Layout table for location contacts
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

Sponsors and Collaborators
University of Iowa
US Department of Veterans Affairs

Layout table for additonal information
Responsible Party: Philip Polgreen, Professor of Medicine, 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: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Philip Polgreen, University of Iowa:
Veterans

Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Body Weight
Signs and Symptoms