Sedentary LifestyleNCT03109509
Testing the Efficacy of Pokemon Go for Increasing Physical Activity
A study testing Fitbit + Pokemon Go and Fitbit Only in people with Sedentary Lifestyle, run by University of Iowa.
Trial summary
Historically, increasing activity was synonymous with exercise; however, it is now thought that even much more modest activity levels (e.g., simply walking) or merely decreasing the proportion of sedentary time may be sufficient to decrease future morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Fitbit + Pokemon Go and Fitbit Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years of age, healthy adults, own smart phone, have access to the Internet, fluent in English, no contraindications to physical activity, not pregnant or planning to become pregnant, had not previously played Pokemon Go game
Who cannot join
- <18 year or older than 80 years of age, did not own smart phone, did not have access to the Internet, not fluent in English, any contraindications to physical activity, pregnant or planning to become pregnant in next 2 months, had previously played Pokemon Go game
About this study
Official title: Pokémon Go Modestly Increases Time Spent Active Among Healthy Adults
Historically, increasing activity was synonymous with exercise; however, it is now thought that even much more modest activity levels (e.g., simply walking) or merely decreasing the proportion of sedentary time may be sufficient to decrease future morbidity and mortality. Some interventions designed to increase activity have shown promise; others have been less successful. But even promising interventions are often difficult to generalize to real-life clinical settings. One barrier to monitoring the effectiveness of interventions has been the lack of availability of accurate, reliable and inexpensive personal activity monitoring equipment. The availability of inexpensive pedometers, and, more recently, low cost triaxial accelerometers, has now made it much easier to monitor activity levels and provide feedback to users. These devices are ideal for capturing activity associated with walking, the most popular and acceptable form of exercise, but only if patients actually wear them. Thus, there is a need to develop pragmatic approaches that encourage patients to not only wear these monitoring devices, but also motivate them to increase their activity.
In recent years, games have been used in a variety of settings to motivate and change behavior. Games not only provide performance feedback to patients, but also provide incentives for achieving goals in a context that is fun, intrinsically rewarding, and easy to understand. Successful games effectively exploit motivating social factors (e.g., competition, peer support, and entertainment) to maintain interest and engage participants. Steps are counted using a commercially available triaxial accelerometer (e.g., a FitBit). Pokemon Go is an augmented reality game that encourages players to go outside to search for Pokemon creatures.
- Conditions
- Sedentary Lifestyle
- Being tested
- Fitbit + Pokemon Go, 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 + Pokemon GoBehavioural
Participants received a Fitbit Zip to wear daily for 8 weeks. Participants also received access to the Pokemon Go game.
Fitbit OnlyBehavioural
Participants received a Fitbit Zip to wear daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fitbit-only Group | Active comparator | Participants randomized to the FB group were provided a Fitbit Zip activity monitor and were instructed on how to wear the monitor, how to pair the activity monitor to their smartphone, and asked to provide our team consent to access their Fitbit data through Fitbit's Application Programming Interface (API) Receives: Behavioral: Fitbit Only |
| Fitbit + Pokémon Go Group | Experimental | Participants randomized to the FB+P group received the same Fitbit Zip activity monitor and text message reminders as the FB group. This group was also shown how to download the Pokémon Go application to their smartphone and were provided brief instructions on how to play the game. Participants were instructed to simply explore the game and play it at their leisure. Participants were not provided any specific goals related to game play or physical activity in general. Receives: Behavioral: Fitbit + Pokemon Go |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily steps
Daily steps measured by Fitbit Zip
Measured: Eight 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 start20 Jul 2016
- Primary completion30 Oct 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Model description
- Two-group, randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Lucas Carr, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109509
- Sponsor's protocol ID
- 201607768
- Other IDs
- 5K25HL122305
- Status last verified
- Apr 2017
- First submitted
- 5 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: No plan to share individual data with other researchers.
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
- Pokémon Go Modestly Increases Time Spent Active Among Healthy Adults
- ClinicalTrials.gov ID
- NCT03109509
- Acronym / sponsor ID
- 201607768
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 30 Oct 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.
Historically, increasing activity was synonymous with exercise; however, it is now thought that even much more modest activity levels (e.g., simply walking) or merely decreasing the proportion of sedentary time may be sufficient to decrease future morbidity and mortality. Some interventions designed to increase activity have shown promise; others have been less successful. But even promising interventions are often difficult to generalize to real-life clinical settings. One barrier to monitoring the effectiveness of interventions has been the lack of availability of accurate, reliable and inexpensive personal activity monitoring equipment. The availability of inexpensive pedometers, and, more recently, low cost triaxial accelerometers, has now made it much easier to monitor activity levels and provide feedback to users. These devices are ideal for capturing activity associated with walking, the most popular and acceptable form of exercise, but only if patients actually wear them. Thus, there is a need to develop pragmatic approaches that encourage patients to not only wear these monitoring devices, but also motivate them to increase their activity.
In recent years, games have been used in a variety of settings to motivate and change behavior. Games not only provide performance feedback to patients, but also provide incentives for achieving goals in a context that is fun, intrinsically rewarding, and easy to understand. Successful games effectively exploit motivating social factors (e.g., competition, peer support, and entertainment) to maintain interest and engage participants. Steps are counted using a commercially available triaxial accelerometer (e.g., a FitBit). Pokemon Go is an augmented reality game that encourages players to go outside to search for Pokemon creatures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two-group, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Fitbit-only Group | Active comparator | Behavioral: Fitbit OnlyParticipants randomized to the FB group were provided a Fitbit Zip activity monitor and were instructed on how to wear the monitor, how to pair the activity monitor to their smartphone, and asked to provide our team consent to access their Fitbit data through Fitbit's Application Programming Interface (API) |
| Fitbit + Pokémon Go Group | Experimental | Behavioral: Fitbit + Pokemon GoParticipants randomized to the FB+P group received the same Fitbit Zip activity monitor and text message reminders as the FB group. This group was also shown how to download the Pokémon Go application to their smartphone and were provided brief instructions on how to play the game. Participants were instructed to simply explore the game and play it at their leisure. Participants were not provided any specific goals related to game play or physical activity in general. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-80 years of age, healthy adults, own smart phone, have access to the Internet, fluent in English, no contraindications to physical activity, not pregnant or planning to become pregnant, had not previously played Pokemon Go game
Key exclusion criteria (1 listed)
- <18 year or older than 80 years of age, did not own smart phone, did not have access to the Internet, not fluent in English, any contraindications to physical activity, pregnant or planning to become pregnant in next 2 months, had previously played Pokemon Go game
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 + Pokemon GoParticipants received a Fitbit Zip to wear daily for 8 weeks. Participants also received access to the Pokemon Go game. | Behavioural | Fitbit + Pokémon Go Group |
| Fitbit OnlyParticipants received a Fitbit Zip to wear daily for 8 weeks. | Behavioural | Fitbit-only Group |
Primary outcome
Average daily steps
Time frame: Eight weeks
Daily steps measured by Fitbit Zip
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.
- Individual participant dataSharing planned: No. No plan to share individual data with other researchers.
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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 + Pokemon Go 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: Eight weeks). 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 28 Apr 2017.