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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03193229
Enrollment
430
Registered
2017-06-20
Start date
2017-05-15
Completion date
2018-05-04
Last updated
2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Pre Diabetes

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.

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

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Philip Polgreen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
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

* Pregnancy * Prisoner status * Taking insulin or other diabetic medications

Design outcomes

Primary

MeasureTime frameDescription
Total number of steps per day6 monthsThe Fitbit will provide the total number of steps that each patient has taken per day.

Secondary

MeasureTime frameDescription
Pace of steps per day6 monthsThe Fitbit will provide the number of steps taken per minute (pace) per day.

Other

MeasureTime frameDescription
Sedentary minutes per day6 monthsThe Fitbit will provide the number of minutes spent being sedentary per day.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026