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

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ClinicalTrials.gov Identifier: NCT03193229
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Philip Polgreen, University of Iowa

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : April 2, 2018
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Total number of steps per day [ Time Frame: 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 [ Time Frame: 6 months ]
    The Fitbit will provide the number of steps taken per minute (pace) per day.


Other Outcome Measures:
  1. Sedentary minutes per day [ Time Frame: 6 months ]
    The Fitbit will provide the number of minutes spent being sedentary per day.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193229


Locations
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United States, Iowa
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
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Principal Investigator: Phil Polgreen, MD Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation

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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     History of Changes
Other Study ID Numbers: 201505733
1R21DK108019-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia