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CompletedNCT03193229Updated Oct 16, 2018

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

An interventional study of MapTrek and Fitbit in Pre Diabetes and Obesity, sponsored by Philip Polgreen. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-16.

Sponsored by Philip Polgreen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
430
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pre Diabetes
  • Obesity
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 430 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Philip Polgreen is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  • Pregnancy
  • Prisoner status
  • Taking insulin or other diabetic medications
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
430 participants (actual)

Study arms

  • 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 · Device: 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

Interventions

  • BehavioralMapTrek

    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.

  • DeviceFitbit

    Fitbit

06

What researchers measure

Primary outcomes

  1. Total number of steps per day

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

    Time frame: 6 months

Secondary outcomes

  1. Pace of steps per day

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

    Time frame: 6 months

Other outcomes

  1. Sedentary minutes per day

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

    Time frame: 6 months

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Study locations

1 site
  • Signal Center Innovation Lab
    Coralville, Iowa 52241, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03193229
Lead sponsor
Philip Polgreen
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Philip Polgreen (Associate Professor of Medicine and Epidemiology; Director of Innovation Lab for Signal Center for Clinical Innovation, University of Iowa) — Sponsor-investigator
First posted
Jun 20, 2017
Start date
May 15, 2017
Primary completion
Apr 2, 2018
Completion
May 4, 2018
Last update
Oct 16, 2018

Study contacts

Phil Polgreen, MD
principal investigator · Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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