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

Obesity Clinical Trial

Official title:

MapTrek, an Interactive, m-Health Intervention to Increase Activity Among Patients at Risk for Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193229
• Other study ID #: 201505733
• Secondary ID: 1R21DK108019-01A
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: May 4, 2018

Study information

• Verified date: October 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: May 4, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Obesity
• Pre Diabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	Signal Center Innovation Lab	Coralville	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Philip Polgreen	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sedentary minutes per day	The Fitbit will provide the number of minutes spent being sedentary per day.	6 months
Primary	Total number of steps per day	The Fitbit will provide the total number of steps that each patient has taken per day.	6 months
Secondary	Pace of steps per day	The Fitbit will provide the number of steps taken per minute (pace) per day.	6 months