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

NCT03193229 | Completed

• 2 other identifiers: 2015057331R21DK108019-01A1
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pace of steps per day

  6 months

Other Outcomes (1)

• Sedentary minutes per day

  6 months

Study Arms (2)

MapTrek

EXPERIMENTAL

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; Device: Fitbit

Fitbit Only

ACTIVE COMPARATOR

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

Interventions

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.

MapTrek

Fitbit DEVICE

Fitbit

Fitbit Only; MapTrek

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• Philip Polgreen: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Signal Center Innovation Lab

Coralville, Iowa, 52241, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Phil Polgreen, MD

  Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine and Epidemiology; Director of Innovation Lab for Signal Center for Clinical Innovation

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 20, 2017
• Study Start: May 15, 2017
• Primary Completion: April 2, 2018
• Study Completion: May 4, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)