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

NCT ID: NCT03193229

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2018-05-04

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.

Conditions

Pre Diabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MapTrek

Intervention Type: BEHAVIORAL

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.

Fitbit

Intervention Type: DEVICE

Fitbit

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.

Group Type: ACTIVE_COMPARATOR

Fitbit

Intervention Type: DEVICE

Fitbit

Interventions

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.

Intervention Type: BEHAVIORAL

Fitbit

Fitbit

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Philip Polgreen

OTHER

Sponsor Role: lead

Responsible Party

Philip Polgreen

Associate Professor of Medicine and Epidemiology; Director of Innovation Lab for Signal Center for Clinical Innovation

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Phil Polgreen, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation

Locations

Signal Center Innovation Lab

Coralville, Iowa, United States

Countries

United States

Other Identifiers

1R21DK108019-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201505733

Identifier Type: -

Identifier Source: org_study_id