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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Pre Diabetes
• Intervention / Treatment: Behavioral: MapTrek; Device: Fitbit

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.

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Coralville, Iowa, United States, 52241
      • Signal Center Innovation Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MapTrek; 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; 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.; Device: Fitbit; Fitbit
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.	Device: Fitbit; Fitbit

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedentary minutes per day	The Fitbit will provide the number of minutes spent being sedentary per day.	6 months

Collaborators and Investigators

• Sponsor: Philip Polgreen
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Phil Polgreen, MD, Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): April 2, 2018
• Study Completion (Actual): May 4, 2018

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 201505733; 1R21DK108019-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No