<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03757676</url>
  </required_header>
  <id_info>
    <org_study_id>HS-2017-0235</org_study_id>
    <nct_id>NCT03757676</nct_id>
  </id_info>
  <brief_title>Effects of Playing Pokemon Go on Physical Activity</brief_title>
  <official_title>Effects of Playing Pokemon Go on Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>San Diego State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to test the feasibility and preliminary efficacy of playing&#xD;
      Pokémon Go to increase daily steps among young adults. The study also aimed to assess&#xD;
      people's experience playing the game, identify specific features of the game that users&#xD;
      like/dislike, and explore game features that may promote overall well-being.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study participants were 30 undergraduate students from a State university in California who&#xD;
      were 18 years or older, enrolled full-time, non-Pokémon Go players, and were able to walk&#xD;
      leisurely. Daily steps were measured for 6 consecutive weeks via the Fitbit Flex 2. Habitual&#xD;
      activity was first measured during the first two-weeks. After the 2-week baseline assessment&#xD;
      of physical activity and GPS travel patterns, participants were randomized to one of three&#xD;
      study conditions for the remaining 4 weeks: (1) &quot;No Play,&quot; (2) &quot;Play At Will,&quot; or (3) &quot;Goal&#xD;
      Oriented Play&quot;. The 4-week intervention period was followed by a post-study interview&#xD;
      completed within one week from the end of the intervention period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">March 22, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants were randomly assigned into one of three experimental groups: a control group and two play groups. The two play groups consisted of a group that was asked to play Pokémon Go ad libitum (at will play) and the other group was asked to achieve a specific level within the game during the study period (goal oriented play). Participants were measured for baseline physical activity levels (2 weeks) followed by randomization to one of the three groups. The intervention period lasted 4 weeks. All participants completed a brief questionnaire and were measured for height and weight, and daily physical activity levels using a FitBit accelerometer. Locations of where individual engaged in physical activity were recorded using a GPS tracking application. During the 5th week of the study period, participants completed five (5) short surveys per day using Ecological Momentary Assessment (EMA) software to assess level of play and engagement of play.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Steps per day</measure>
    <time_frame>Six weeks</time_frame>
    <description>Steps per day measured via the Fitbit</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>No Play</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This 'no play' group functioned as the control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>At Will Play</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group functioned as 1 of the 2 play groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Goal Oriented Play</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group functioned as 1 of the 2 play groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No Play</intervention_name>
    <description>Participants in this group were asked not to download or play Pokémon Go during the study period and were asked to simply continue with their normal daily activities. Participants were asked to wear the Fitbit device and use the GPS app on their mobile phones during the 6-week study period. Starting the fifth week, participants were prompted to complete five (5) brief daily surveys on their phones via the EMA app.</description>
    <arm_group_label>No Play</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>At Will Play</intervention_name>
    <description>Participants in this group were asked to download Pokémon Go and play for at least 30 minutes initially, then play as much or as little as desired during the 4 week intervention period, with no specific instruction or goals for play. Participants were asked to wear the Fitbit device and use the GPS app on their mobile phones during the 6-week study period. Starting the fifth week, participants were prompted to complete five (5) brief daily surveys on their phones via the EMA app.</description>
    <arm_group_label>At Will Play</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Goal Oriented Play</intervention_name>
    <description>Participants in this group were asked to download and play Pokémon Go and achieve a minimum player level of 20 within the game during the study period. They were given materials that described game features and functions to show them how to play the game. There were no restrictions on which features to pursue within the game to achieve this goal nor on how long or how frequent their play sessions should be. Upon reaching their goal (Level 20), participants were encouraged to continue to play as much or as little as they desired. Participants were asked to wear the Fitbit device and use the GPS app on their mobile phones during the 6-week study period. Starting the fifth week, participants were prompted to complete five (5) brief daily surveys on their phones via the EMA app.</description>
    <arm_group_label>Goal Oriented Play</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled as a full-time undergraduate or graduate student at participating University&#xD;
&#xD;
          -  Willingness to be randomized to one of the three study conditions&#xD;
&#xD;
          -  Never played or a Novice Player of Pokemon Go (Cannot have previously exceeded Level&#xD;
             5)&#xD;
&#xD;
          -  Not currently meeting physical activity guidelines for adults (i.e., 150 minutes per&#xD;
             week of moderate-intensity aerobic activity and/or 75 minutes per week of&#xD;
             vigorous-intensity aerobic activity). Assessed via the GPAQ questionnaire.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Unable to leisurely walk for 30 minutes consecutively&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noe C Crespo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Behavioral and Community Health</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Noe Crespo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Mobile Games</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03757676
org study id: HS-2017-0235
nct id: NCT03757676
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to test the feasibility and preliminary efficacy of playing
      Pokémon Go to increase daily steps among young adults. The study also aimed to assess
      people's experience playing the game, identify specific features of the game that users
      like/dislike, and explore game features that may promote overall well-being.
Study participants were 30 undergraduate students from a State university in California who
      were 18 years or older, enrolled full-time, non-Pokémon Go players, and were able to walk
      leisurely. Daily steps were measured for 6 consecutive weeks via the Fitbit Flex 2. Habitual
      activity was first measured during the first two-weeks. After the 2-week baseline assessment
      of physical activity and GPS travel patterns, participants were randomized to one of three
      study conditions for the remaining 4 weeks: (1) "No Play," (2) "Play At Will," or (3) "Goal
      Oriented Play". The 4-week intervention period was followed by a post-study interview
      completed within one week from the end of the intervention period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomly assigned into one of three experimental groups: a control group and two play groups. The two play groups consisted of a group that was asked to play Pokémon Go ad libitum (at will play) and the other group was asked to achieve a specific level within the game during the study period (goal oriented play). Participants were measured for baseline physical activity levels (2 weeks) followed by randomization to one of the three groups. The intervention period lasted 4 weeks. All participants completed a brief questionnaire and were measured for height and weight, and daily physical activity levels using a FitBit accelerometer. Locations of where individual engaged in physical activity were recorded using a GPS tracking application. During the 5th week of the study period, participants completed five (5) short surveys per day using Ecological Momentary Assessment (EMA) software to assess level of play and engagement of play.
primary purpose: Other
masking: Single (Participant)
measure: Steps per day
time frame: Six weeks
description: Steps per day measured via the Fitbit
arm group label: No Play
arm group type: Experimental
description: This 'no play' group functioned as the control group.
arm group label: At Will Play
arm group type: Experimental
description: This group functioned as 1 of the 2 play groups.
arm group label: Goal Oriented Play
arm group type: Experimental
description: This group functioned as 1 of the 2 play groups.
intervention type: Behavioral
intervention name: No Play
description: Participants in this group were asked not to download or play Pokémon Go during the study period and were asked to simply continue with their normal daily activities. Participants were asked to wear the Fitbit device and use the GPS app on their mobile phones during the 6-week study period. Starting the fifth week, participants were prompted to complete five (5) brief daily surveys on their phones via the EMA app.
arm group label: No Play
intervention type: Behavioral
intervention name: At Will Play
description: Participants in this group were asked to download Pokémon Go and play for at least 30 minutes initially, then play as much or as little as desired during the 4 week intervention period, with no specific instruction or goals for play. Participants were asked to wear the Fitbit device and use the GPS app on their mobile phones during the 6-week study period. Starting the fifth week, participants were prompted to complete five (5) brief daily surveys on their phones via the EMA app.
arm group label: At Will Play
intervention type: Behavioral
intervention name: Goal Oriented Play
description: Participants in this group were asked to download and play Pokémon Go and achieve a minimum player level of 20 within the game during the study period. They were given materials that described game features and functions to show them how to play the game. There were no restrictions on which features to pursue within the game to achieve this goal nor on how long or how frequent their play sessions should be. Upon reaching their goal (Level 20), participants were encouraged to continue to play as much or as little as they desired. Participants were asked to wear the Fitbit device and use the GPS app on their mobile phones during the 6-week study period. Starting the fifth week, participants were prompted to complete five (5) brief daily surveys on their phones via the EMA app.
arm group label: Goal Oriented Play
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Noe C Crespo, PhD
role: Principal Investigator
affiliation: San Diego State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Noe Crespo
investigator title: Assistant Professor