MapTrek to Increase Activity Among Patients at Risk for Type 2 Diabetes
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03193229|
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pre Diabetes Obesity||Behavioral: MapTrek Device: Fitbit||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MapTrek, an Interactive, m-Health Intervention to Increase Activity Among Patients at Risk for Type 2 Diabetes|
|Actual Study Start Date :||May 15, 2017|
|Actual Primary Completion Date :||April 2, 2018|
|Actual Study Completion Date :||May 4, 2018|
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.
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.
Active Comparator: Fitbit Only
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.
- Total number of steps per day [ Time Frame: 6 months ]The Fitbit will provide the total number of steps that each patient has taken per day.
- Pace of steps per day [ Time Frame: 6 months ]The Fitbit will provide the number of steps taken per minute (pace) per day.
- Sedentary minutes per day [ Time Frame: 6 months ]The Fitbit will provide the number of minutes spent being sedentary per day.
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): NCT03193229
|United States, Iowa|
|Signal Center Innovation Lab|
|Coralville, Iowa, United States, 52241|
|Principal Investigator:||Phil Polgreen, MD||Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation|