Pre DiabetesNCT03193229
MapTrek to Increase Activity Among Patients at Risk for Type 2 Diabetes
A study testing MapTrek and Fitbit in people with Pre Diabetes and Obesity, run by Philip Polgreen at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes, Obesity
- What is being tested?
- MapTrek and Fitbit
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2017to 4 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Prisoner status
- Taking insulin or other diabetic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Signal Center Innovation Lab
Coralville, Iowa, 52241
About this study
Official title: MapTrek, an Interactive, m-Health Intervention 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.
Read the 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.
- Conditions
- Pre Diabetes, Obesity
- Being tested
- MapTrek, Fitbit
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MapTrekBehavioural
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.
FitbitDevice
Fitbit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of steps per day
The Fitbit will provide the total number of steps that each patient has taken per day.
Measured: 6 months
Secondary outcomes (1)
Pace of steps per day
The Fitbit will provide the number of steps taken per minute (pace) per day.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start15 May 2017
- Primary completion2 Apr 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Polgreen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philip Polgreen, University of Iowa
- Investigators
- Phil Polgreen, MD, Principal investigator, Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193229
- Sponsor's protocol ID
- 201505733
- Other IDs
- 1R21DK108019-01A1
- Status last verified
- Oct 2018
- First submitted
- 13 Jun 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MapTrek, an Interactive, m-Health Intervention to Increase Activity Among Patients at Risk for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03193229
- Acronym / sponsor ID
- 201505733
- Conditions
- Pre Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Philip PolgreenUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MapTrek | Experimental | Behavioral: MapTrek, Device: FitbitPatients 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. |
| Fitbit Only | Active comparator | Device: FitbitPatients 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Prisoner status
- Taking insulin or other diabetic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MapTrekThe 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. | Behavioural | MapTrek |
| FitbitFitbit | Device | Fitbit Only, MapTrek |
Primary outcome
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.
1 secondary outcome
Pace of steps per day
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phil Polgreen, MD principal investigator
Associate Professor of Infectious Diseases and Director of Signal Center for Clinical Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MapTrek and Fitbit in people with Pre Diabetes and Obesity, run by Philip Polgreen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of steps per day (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.