MapTrek to Increase Activity Among Patients at Risk for Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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MapTrek, an Interactive, m-Health Intervention to Increase Activity Among Patients at Risk for Type 2 Diabetes

Conditions
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Pre Diabetes, Obesity

Intervention / Treatment
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* Behavioral: MapTrek
* Device: Fitbit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MapTrek<br>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. | Behavioral: MapTrek<br>* 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.<br>Device: Fitbit<br>* Fitbit<br>|
| Active Comparator: Fitbit Only<br>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. | Device: Fitbit<br>* Fitbit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of steps per day | The Fitbit will provide the total number of steps that each patient has taken per day. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pace of steps per day | The Fitbit will provide the number of steps taken per minute (pace) per day. | 6 months |