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

• Sponsor: Philip Polgreen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03193229
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 430
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.6
• Patients Per Site Per Month: 37

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pre Diabetes; Obesity	Behavioral: MapTrek; Device: Fitbit	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 430 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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: Apr 2, 2018
• Actual Study Completion Date: May 4, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Total number of steps per day [6 months]

   The Fitbit will provide the total number of steps that each patient has taken per day.

Secondary Outcome Measures

1. Pace of steps per day [6 months]

   The Fitbit will provide the number of steps taken per minute (pace) per day.

Other Outcome Measures

1. Sedentary minutes per day [6 months]

   The Fitbit will provide the number of minutes spent being sedentary per day.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Signal Center Innovation Lab	Coralville	Iowa	United States	52241

Sponsors and Collaborators

• Philip Polgreen
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philip Polgreen, Associate Professor of Medicine and Epidemiology; Director of Innovation Lab for Signal Center for Clinical Innovation, University of Iowa
• ClinicalTrials.gov Identifier: NCT03193229
• Other Study ID Numbers: 201505733; 1R21DK108019-01A1
• First Posted: Jun 20, 2017
• Last Update Posted: Oct 16, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Prediabetic State

Study Results

No Results Posted as of Oct 16, 2018