NCT03109509

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

April 5, 2017

Last Update Submit

April 26, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average daily steps

    Daily steps measured by Fitbit Zip

    Eight weeks

Study Arms (2)

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)

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.

Behavioral: Fitbit + Pokemon Go

Interventions

Participants received a Fitbit Zip to wear daily for 8 weeks. Participants also received access to the Pokemon Go game.

Fitbit + Pokémon Go Group
Fitbit OnlyBEHAVIORAL

Participants received a Fitbit Zip to wear daily for 8 weeks.

Fitbit-only Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Research team was blinded to participant group assignment until data analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two-group, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 12, 2017

Study Start

July 20, 2016

Primary Completion

October 30, 2016

Study Completion

April 1, 2017

Last Updated

April 28, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

No plan to share individual data with other researchers.