Sedentary LifestyleNCT03109535
MapTrek for Sedentary Workers
A study testing Fitbit + Maptrek and Fitbit only in people with Sedentary Lifestyle, run by University of Iowa.
Trial summary
The aim of this study is to determine if participants randomized to our mHealth MapTrek game increases daily physical activity (average steps/day, active minutes/day) compared to a control group among sedentary office workers over 10 weeks. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Fitbit + Maptrek and Fitbit only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Apr 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible participants were 21 to 65 year of age, working full-time (at least 35 hours/week) in a desk-dependent job (self-report sitting >75% of work day), who owned a smart phone.
Who cannot join
- Exclusion criteria included ages <18 years or >65 years, pregnancy or planned pregnancy, prisoner status, and any contraindications to engaging in regular physical activity as identified by the Physical Activity Readiness Questionnaire (PAR-Q), not owning a smart phone, (Cardinal, Esters, \& Cardinal, 1996).
About this study
The aim of this study is to determine if participants randomized to our mHealth MapTrek game increases daily physical activity (average steps/day, active minutes/day) compared to a control group among sedentary office workers over 10 weeks. The investigators hypothesize the MapTrek intervention group will significantly increase their daily steps and active minutes compared to the control group over 10 weeks.
- Conditions
- Sedentary Lifestyle
- Being tested
- Fitbit + Maptrek, Fitbit only
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit + MaptrekBehavioural
Users receive a Fitbit Zip to wear daily. Users aslo receive the mHealth MapTrek game that places users in weekly walking races and sends automated text messages to users on a daily basis for the purpose of increasing daily physical activity.
Fitbit onlyBehavioural
Users receive a Fitbit Zip to wear daily.
| Study group | Role | What they receive |
|---|---|---|
| Fitbit-only Group | Active comparator | Participants received a Fitbit Zip activity monitor to wear daily for 10 weeks. Receives: Behavioral: Fitbit only |
| Fitbit + MapTrek Group | Experimental | Participants received a Fitbit Zip activity monitor to wear daily for 10 weeks. Participants also received access to an mHealth game called MapTrek for 10 weeks. MapTrek places users in weekly walking races and sends automated text messages to participants on a daily basis. Messages include a link to the online game as well as motivational messages designed to increase physical activity. Receives: Behavioral: Fitbit + Maptrek |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily steps
Total daily steps as recorded by the Fitbit Zip
Measured: 10 weeks
Secondary outcomes (1)
Average daily active minutes
Minutes with at least 100 steps/minute as recorded by the Fitbit Zip
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Sep 2016
- Primary completion15 Dec 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Carr, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109535
- Sponsor's protocol ID
- 201608733
- Status last verified
- Apr 2017
- First submitted
- 6 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gremaud AL, Carr LJ, Simmering JE, Evans NJ, Cremer JF, Segre AM, Polgreen LA, Polgreen PM. Gamifying Accelerometer Use Increases Physical Activity Levels of Sedentary Office Workers. J Am Heart Assoc. 2018 Jul 2;7(13):e007735. doi: 10.1161/JAHA.117.007735.
PubMed 29967221
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MapTrek for Sedentary Workers
- ClinicalTrials.gov ID
- NCT03109535
- Acronym / sponsor ID
- 201608733
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 12 Apr 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 aim of this study is to determine if participants randomized to our mHealth MapTrek game increases daily physical activity (average steps/day, active minutes/day) compared to a control group among sedentary office workers over 10 weeks. The investigators hypothesize the MapTrek intervention group will significantly increase their daily steps and active minutes compared to the control group over 10 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit-only Group | Active comparator | Behavioral: Fitbit onlyParticipants received a Fitbit Zip activity monitor to wear daily for 10 weeks. |
| Fitbit + MapTrek Group | Experimental | Behavioral: Fitbit + MaptrekParticipants received a Fitbit Zip activity monitor to wear daily for 10 weeks. Participants also received access to an mHealth game called MapTrek for 10 weeks. MapTrek places users in weekly walking races and sends automated text messages to participants on a daily basis. Messages include a link to the online game as well as motivational messages designed to increase physical activity. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants were 21 to 65 year of age, working full-time (at least 35 hours/week) in a desk-dependent job (self-report sitting >75% of work day), who owned a smart phone.
Key exclusion criteria (1 listed)
- Exclusion criteria included ages <18 years or >65 years, pregnancy or planned pregnancy, prisoner status, and any contraindications to engaging in regular physical activity as identified by the Physical Activity Readiness Questionnaire (PAR-Q), not owning a smart phone, (Cardinal, Esters, \& Cardinal, 1996).
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 |
|---|---|---|
| Fitbit + MaptrekUsers receive a Fitbit Zip to wear daily. Users aslo receive the mHealth MapTrek game that places users in weekly walking races and sends automated text messages to users on a daily basis for the purpose of increasing daily physical activity. | Behavioural | Fitbit + MapTrek Group |
| Fitbit onlyUsers receive a Fitbit Zip to wear daily. | Behavioural | Fitbit-only Group |
Primary outcome
Average daily steps
Time frame: 10 weeks
Total daily steps as recorded by the Fitbit Zip
1 secondary outcome
Average daily active minutes
Time frame: 10 weeks
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 28 Apr 2017.
- Derived from this study: PubMed 29967221Gremaud AL, Carr LJ, Simmering JE, Evans NJ, Cremer JF, Segre AM, Polgreen LA, Polgreen PM. Gamifying Accelerometer Use Increases Physical Activity Levels of Sedentary Office Workers. J Am Heart Assoc. 2018 Jul 2;7(13):e007735. doi: 10.1161/JAHA.117.007735.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit + Maptrek and Fitbit only in people with Sedentary Lifestyle, run by University of Iowa.
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 1 inclusion and 1 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Average daily steps (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03109535, which also lists 1 linked publication.
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 28 Apr 2017.