Back to resultsMapTrek to Increase Activity Among Patients at Risk for Type 2 Diabetes
Primary Purpose
Pre Diabetes, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MapTrek
Fitbit
Sponsored by
About this trial
This is an interventional prevention trial for Pre Diabetes
Eligibility Criteria
Inclusion Criteria:
- At least 21 years old
- English speaker
- Have a smart phone with texting and internet capabilities
- No aversion to research studies
- No active mental health conditions
- 1) Have a BMI > or equal to 25 and a history of hemoglobin A1C level between 5.7 and 6.4%, or 2) have a BMI > or equal to 30.
Exclusion Criteria:
- Pregnancy
- Prisoner status
- Taking insulin or other diabetic medications
Sites / Locations
- Signal Center Innovation Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MapTrek
Fitbit Only
Arm Description
Patients in the intervention group receive a Fitbit and MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required prior to enrollment). Each week, patients 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. MapTrek also supports Street View on Google Maps, so patients can explore what they would see if they were in that location. Throughout each race, patients will randomly receive challenge text messages. Completing a challenge awards bonus steps to propel their character along the map.
Patients randomized to the control group will receive a Fitbit only. This will allow us to determine if changes in physical activity are due to MapTrek or simply by giving the patients a Fitbit.
Outcomes
Primary Outcome Measures
Total number of steps per day
The Fitbit will provide the total number of steps that each patient has taken per day.
Secondary Outcome Measures
Pace of steps per day
The Fitbit will provide the number of steps taken per minute (pace) per day.
Full Information
NCT ID
NCT03193229
First Posted
June 13, 2017
Last Updated
October 15, 2018
Sponsor
Philip Polgreen
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03193229
Brief Title
MapTrek to Increase Activity Among Patients at Risk for Type 2 Diabetes
Official Title
MapTrek, an Interactive, m-Health Intervention to Increase Activity Among Patients at Risk for Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
April 2, 2018 (Actual)
Study Completion Date
May 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Philip Polgreen
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
The overarching objective of our work is to provide an inexpensive and scalable m-health tool to increase both volume and intensity of physical activity and reduce sedentary behavior in patients at risk for type 2 diabetes. The objective of this study is to pilot test MapTrek, a text-messaging based intervention.
Detailed Description
This study will randomize participants to 2 groups, an intervention group that will receive a Fitbit and MapTrek, and a control group that will receive a Fitbit only. This study has 3 specific aims.
Aim 1- To determine if patients randomized to MapTrek walk more than the control patients.
Aim 2- To determine if patients randomized to MapTrek generally walk at a faster pace during the day than control patients.
Aim 3- To determine if patients randomized to MapTrek have less sedentary time during the day than the control patients.
We expect to collect sufficient data to demonstrate the effectiveness of MapTrek, our prototype m-health tool, as an intervention to increase physical activity, heighten intensity of activity, and reduce sedentary behavior among a cohort of patients at risk for type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MapTrek
Arm Type
Experimental
Arm Description
Patients in the intervention group receive a Fitbit and MapTrek, an interactive text-messaging platform. The only equipment needed is a Fitbit (we provide) and a smartphone (required prior to enrollment). Each week, patients 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. MapTrek also supports Street View on Google Maps, so patients can explore what they would see if they were in that location. Throughout each race, patients 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
Patients randomized to the control group will receive a Fitbit only. This will allow us to determine if changes in physical activity are due to MapTrek or simply by giving the patients a Fitbit.
Intervention Type
Behavioral
Intervention Name(s)
MapTrek
Intervention Description
The objective of the study is to provide an inexpensive and scalable m-health tool to increase both volume and intensity of physical activity and reduce sedentary behavior in patients at risk for or already diagnosed with pre-diabetes.
Intervention Type
Device
Intervention Name(s)
Fitbit
Intervention Description
Fitbit
Primary Outcome Measure Information:
Title
Total number of steps per day
Description
The Fitbit will provide the total number of steps that each patient has taken per day.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pace of steps per day
Description
The Fitbit will provide the number of steps taken per minute (pace) per day.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Sedentary minutes per day
Description
The Fitbit will provide the number of minutes spent being sedentary per day.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 21 years old
English speaker
Have a smart phone with texting and internet capabilities
No aversion to research studies
No active mental health conditions
1) Have a BMI > or equal to 25 and a history of hemoglobin A1C level between 5.7 and 6.4%, or 2) have a BMI > or equal to 30.
Exclusion Criteria:
Pregnancy
Prisoner status
Taking insulin or other diabetic medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phil Polgreen, MD
Organizational Affiliation
Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Signal Center Innovation Lab
City
Coralville
State/Province
Iowa
ZIP/Postal Code
52241
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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MapTrek to Increase Activity Among Patients at Risk for Type 2 Diabetes
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