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

Not Applicable

Completed

• Conditions: Pre Diabetes; Obesity

• Registration Number: NCT03193229
• Lead Sponsor: Philip Polgreen

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.

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Primary Completion: 2018-04-02
• Study Completion: 2018-05-04
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pace of steps per day	6 months	The Fitbit will provide the number of steps taken per minute (pace) per day.

Trial Locations

Locations (1)

Signal Center Innovation Lab; 🇺🇸 Coralville, Iowa, United States