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OpenTrials
Completed

NCT Number: NCT03193229

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

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.

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Key information

Conditions

Pre Diabetes Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Signal Center Innovation Lab

Coralville, Iowa, 52241, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MapTrek

Behavioral

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.

Fitbit

Device

Fitbit

Primary outcomes

  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 outcomes

  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 outcomes

  1. Sedentary minutes per day

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Philip Polgreen

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2017
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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