<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/NCT03749473</url>
  </required_header>
  <id_info>
    <org_study_id>831258</org_study_id>
    <nct_id>NCT03749473</nct_id>
  </id_info>
  <brief_title>Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences</brief_title>
  <acronym>ENGAGE</acronym>
  <official_title>Evaluation of the Novel Use of Gamification With Alternative Goal-setting Experiences</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</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>
      To use a randomized controlled trial to test the effectiveness of four goal-setting&#xD;
      strategies within a gamification intervention to increase physical activity among adults at&#xD;
      elevated risk for ASCVD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in the&#xD;
      United States. While increased physical activity can reduce this risk, less than half of&#xD;
      adults in the United States meet the minimum recommendation guidelines for physical activity.&#xD;
      Gamification, or the application of game design elements to non-game settings, has&#xD;
      demonstrated promise in increasing physical activity when designed using insights from&#xD;
      behavioral economics. However, the best way to design goal-setting within these interventions&#xD;
      has not been well-examined. In this randomized controlled trial, the investigators will&#xD;
      evaluate the effectiveness of four different goal-setting strategies within a gamification&#xD;
      intervention to increase physical activity among adults with elevated risk for ASCVD. The&#xD;
      trial will include a 2-week run-in period to estimate a baseline, followed by an 8-week&#xD;
      introductory phase, an 8-week maintenance phase, and then after the intervention is completed&#xD;
      an 8-week follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean daily steps from baseline to maintenance period.</measure>
    <time_frame>Baseline to weeks 9-16</time_frame>
    <description>The primary outcome is change in mean daily steps from baseline to weeks 9-16 (maintenance period).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in mean daily steps from baseline to follow-up period.</measure>
    <time_frame>Baseline to the weeks 17 to 24</time_frame>
    <description>The secondary outcome is change in mean daily steps from baseline to the weeks 17 to 24 (follow-up period).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in minutes of MVPA from baseline to maintenance and follow-up periods.</measure>
    <time_frame>Baseline to weeks 9-16 and weeks 17-24</time_frame>
    <description>An exploratory outcome is change in minutes of moderate-to-vigorous physical activity (MVPA) from baseline to weeks 9-16 (maintenance) and weeks 17-24 (follow-up period).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in minutes of sleep from baseline to maintenance and follow-up periods.</measure>
    <time_frame>Baseline to weeks 9-16 and weeks 17-24</time_frame>
    <description>An exploratory outcome is change in minutes of sleep from baseline to weeks 9-16 (maintenance) and weeks 17-24 (follow-up period).</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Atherosclerotic Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive a daily message with their step count on the prior day to serve as an active control for 24 weeks (daily performance feedback). No other interventions during the 24-week study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Choice + Immediate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants choose a step goal between 1000-3000 steps greater than their baseline (choice). They are asked to reach their full step goal upon intervention start (immediate). They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Choice + Gradual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are asked to choose a step goal between 1000-3000 steps greater than their baseline (choice). They will be asked to increase their step goal by even increments of 12.5% each week for the 8 weeks of the ramp-up period (gradual). After the 8-week ramp-up period, they will be asked to maintain the step goal for the study. They may change their goal within the range at anytime. They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assigned + Immediate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will be assigned a step goal 2000 steps greater than their baseline (assigned). They will be asked to reach their full step goal as soon as the intervention begins (immediate). They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assigned + Gradual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will be assigned a step goal 2000 steps greater than their baseline (assigned). They will be asked to achieve their step goal of 2000 steps incrementally over the 8 weeks of the ramp-up period (gradual). After the first 8 weeks, they will be asked to maintain their full step goal of 2000 for the the study. They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Choice + Immediate</intervention_name>
    <description>Participants in the choice + immediate goal arm will choose a step goal and must attempt to achieve this new step goal immediately at the start of the study.</description>
    <arm_group_label>Choice + Immediate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Choice + Gradual</intervention_name>
    <description>Participants in the choice + gradual goal arm will choose a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.</description>
    <arm_group_label>Choice + Gradual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Assigned + Immediate</intervention_name>
    <description>Participants in the assigned + immediate goal arm will be assigned a step goal and must attempt to achieve this new step goal immediately at the start of the study.</description>
    <arm_group_label>Assigned + Immediate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Assigned + Gradual</intervention_name>
    <description>Participants in the assigned + gradual goal arm will be assigned a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.</description>
    <arm_group_label>Assigned + Gradual</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Daily performance feedback</intervention_name>
    <description>Participants will receive daily performance feedback on their daily step count.</description>
    <arm_group_label>Assigned + Gradual</arm_group_label>
    <arm_group_label>Assigned + Immediate</arm_group_label>
    <arm_group_label>Choice + Gradual</arm_group_label>
    <arm_group_label>Choice + Immediate</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Gamification</intervention_name>
    <description>All participants in the intervention arms will be entered into a gamification platform that has points and levels designed to incorporate insights from behavioral economics.</description>
    <arm_group_label>Assigned + Gradual</arm_group_label>
    <arm_group_label>Assigned + Immediate</arm_group_label>
    <arm_group_label>Choice + Gradual</arm_group_label>
    <arm_group_label>Choice + Immediate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older;&#xD;
&#xD;
          -  ability to read and provide informed consent to participate in the study;&#xD;
&#xD;
          -  diagnosis of clinical ASCVD or a 10-year ASCVD risk score ≥ 7.5% calculated according&#xD;
             to the 2013 ACC/AHA guidelines;&#xD;
&#xD;
          -  Smartphone or tablet compatible with application for the wearable activity tracking&#xD;
             device.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conditions that would make participation infeasible such as inability to provide&#xD;
             informed consent, illiteracy or inability to speak, read, and write English;&#xD;
&#xD;
          -  conditions that would make participation unsafe such as pregnancy or being told by a&#xD;
             physician not to exercise;&#xD;
&#xD;
          -  already enrolled in another study targeting physical activity;&#xD;
&#xD;
          -  any other medical conditions or reasons he or she is unable to participate in a&#xD;
             physical activity study for 24 weeks;&#xD;
&#xD;
          -  baseline step count of 10,000 steps or greater.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitesh S Patel, MD, MBA, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Perelman Center for Advanced Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Mitesh Patel</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Goal-Setting</keyword>
  <keyword>Gamification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be made available</ipd_description>
  </patient_data>
  <!-- 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/NCT03749473
org study id: 831258
nct id: NCT03749473
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To use a randomized controlled trial to test the effectiveness of four goal-setting
      strategies within a gamification intervention to increase physical activity among adults at
      elevated risk for ASCVD.
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in the
      United States. While increased physical activity can reduce this risk, less than half of
      adults in the United States meet the minimum recommendation guidelines for physical activity.
      Gamification, or the application of game design elements to non-game settings, has
      demonstrated promise in increasing physical activity when designed using insights from
      behavioral economics. However, the best way to design goal-setting within these interventions
      has not been well-examined. In this randomized controlled trial, the investigators will
      evaluate the effectiveness of four different goal-setting strategies within a gamification
      intervention to increase physical activity among adults with elevated risk for ASCVD. The
      trial will include a 2-week run-in period to estimate a baseline, followed by an 8-week
      introductory phase, an 8-week maintenance phase, and then after the intervention is completed
      an 8-week follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: Change in mean daily steps from baseline to maintenance period.
time frame: Baseline to weeks 9-16
description: The primary outcome is change in mean daily steps from baseline to weeks 9-16 (maintenance period).
measure: Change in mean daily steps from baseline to follow-up period.
time frame: Baseline to the weeks 17 to 24
description: The secondary outcome is change in mean daily steps from baseline to the weeks 17 to 24 (follow-up period).
measure: Change in minutes of MVPA from baseline to maintenance and follow-up periods.
time frame: Baseline to weeks 9-16 and weeks 17-24
description: An exploratory outcome is change in minutes of moderate-to-vigorous physical activity (MVPA) from baseline to weeks 9-16 (maintenance) and weeks 17-24 (follow-up period).
measure: Change in minutes of sleep from baseline to maintenance and follow-up periods.
time frame: Baseline to weeks 9-16 and weeks 17-24
description: An exploratory outcome is change in minutes of sleep from baseline to weeks 9-16 (maintenance) and weeks 17-24 (follow-up period).
arm group label: Control
arm group type: Active Comparator
description: Participants receive a daily message with their step count on the prior day to serve as an active control for 24 weeks (daily performance feedback). No other interventions during the 24-week study
arm group label: Choice + Immediate
arm group type: Experimental
description: Participants choose a step goal between 1000-3000 steps greater than their baseline (choice). They are asked to reach their full step goal upon intervention start (immediate). They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up
arm group label: Choice + Gradual
arm group type: Experimental
description: Participants are asked to choose a step goal between 1000-3000 steps greater than their baseline (choice). They will be asked to increase their step goal by even increments of 12.5% each week for the 8 weeks of the ramp-up period (gradual). After the 8-week ramp-up period, they will be asked to maintain the step goal for the study. They may change their goal within the range at anytime. They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up
arm group label: Assigned + Immediate
arm group type: Experimental
description: Participants in this arm will be assigned a step goal 2000 steps greater than their baseline (assigned). They will be asked to reach their full step goal as soon as the intervention begins (immediate). They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up
arm group label: Assigned + Gradual
arm group type: Experimental
description: Participants in this arm will be assigned a step goal 2000 steps greater than their baseline (assigned). They will be asked to achieve their step goal of 2000 steps incrementally over the 8 weeks of the ramp-up period (gradual). After the first 8 weeks, they will be asked to maintain their full step goal of 2000 for the the study. They will be in a gamification intervention for the first 16 weeks and then receive only daily feedback during the 8-week follow-up
intervention type: Behavioral
intervention name: Choice + Immediate
description: Participants in the choice + immediate goal arm will choose a step goal and must attempt to achieve this new step goal immediately at the start of the study.
arm group label: Choice + Immediate
intervention type: Behavioral
intervention name: Choice + Gradual
description: Participants in the choice + gradual goal arm will choose a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.
arm group label: Choice + Gradual
intervention type: Behavioral
intervention name: Assigned + Immediate
description: Participants in the assigned + immediate goal arm will be assigned a step goal and must attempt to achieve this new step goal immediately at the start of the study.
arm group label: Assigned + Immediate
intervention type: Behavioral
intervention name: Assigned + Gradual
description: Participants in the assigned + gradual goal arm will be assigned a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.
arm group label: Assigned + Gradual
intervention type: Behavioral
intervention name: Daily performance feedback
description: Participants will receive daily performance feedback on their daily step count.
arm group label: Assigned + Gradual
arm group label: Assigned + Immediate
arm group label: Choice + Gradual
arm group label: Choice + Immediate
arm group label: Control
intervention type: Behavioral
intervention name: Gamification
description: All participants in the intervention arms will be entered into a gamification platform that has points and levels designed to incorporate insights from behavioral economics.
arm group label: Assigned + Gradual
arm group label: Assigned + Immediate
arm group label: Choice + Gradual
arm group label: Choice + Immediate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mitesh S Patel, MD, MBA, MS
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Mitesh Patel
investigator title: Assistant Professor
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
sharing ipd: No
ipd description: Individual participant data will not be made available