xml: <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/NCT06023342</url>
    </required_header>
    <id_info>
      <org_study_id>123207</org_study_id>
      <nct_id>NCT06023342</nct_id>
    </id_info>
    <brief_title>Examining Engagement Predictors of Health and Fitness App Uptake and Subscription in the General Population</brief_title>
    <official_title>Examining Engagement Predictors of Health and Fitness App Uptake and Subscription in the General Population: A 24-week Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Western University, Canada</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Social Sciences and Humanities Research Council of Canada</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Western University, Canada</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>
        This will be a 24-week prospective study that will incorporate user base data of WayBetter&#xD;
        Inc.'s app, &quot;WayBetter,&quot; to examine user mHealth app engagement. The primary objective of&#xD;
        this study is to examine predictors (i.e., socio-demographics, past health behaviours,&#xD;
        psychological determinants, app engagement metrics) of (a) initial six-month subscription and&#xD;
        b) subscription renewal rates at six months for the WayBetter app. The secondary objective is&#xD;
        to characterize WayBetter app engagement over the first 24 weeks of app use.&#xD;
  &#xD;
        Participants will be asked to complete a survey that aims to collect the information&#xD;
        regarding individual-level socio-demographics, previous health behaviours, and&#xD;
        behavioural/personality traits. App engagement metrics will be collected from the WayBetter&#xD;
        app.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a 24-week prospective study that will incorporate user base data of WayBetter&#xD;
        Inc.'s app, &quot;WayBetter,&quot; to examine user mHealth app engagement. The primary objective of&#xD;
        this study is to examine predictors (i.e., socio-demographics, past health behaviours,&#xD;
        psychological determinants, app engagement metrics) of (a) initial six-month subscription and&#xD;
        b) subscription renewal rates at six months for the WayBetter app. The secondary objective is&#xD;
        to characterize WayBetter app engagement over the first 24 weeks of app use. Our study sample&#xD;
        will consist of approximately 400 adult users (aged ≥18 years old), who are new app users&#xD;
        (who have engaged in a 7-day free trial). As users may have varying registration dates, the&#xD;
        data collected will only include the first 24 weeks of an individual's interaction with the&#xD;
        platform.&#xD;
  &#xD;
        WayBetter is a wellness lifestyle mHealth app available to anyone who wants to improve their&#xD;
        overall well-being. All users are asked to accept the company's privacy policy and are&#xD;
        prompted to fill out personal data including (but not limited to) [email address, weight]&#xD;
        when creating an account. All users are given a one-week free trial as well as $10 USD to use&#xD;
        as a deposit towards any WayBetter app game, courtesy of WayBetter Inc. Users can complete&#xD;
        any of the games they signed up for during their free trial, even if they decide not to&#xD;
        continue to their membership. To continue to participate in games, users must subscribe to a&#xD;
        six-month membership ($69 USD total). In general, users can join up to ten games at a time.&#xD;
        The app has a game directory (&quot;explore&quot; tab) that includes 60+ games each week in three&#xD;
        categories: fitness, nutrition, and mindset. New games start on Mondays, Wednesdays, and&#xD;
        Fridays. Each game lasts between 1-4 weeks and requires players to achieve a specific&#xD;
        behavioral goal (e.g., 5K Steps Per Day requires that they walk at least 5,000 steps per day&#xD;
        on at least 4 days per week for 2 weeks). Upon joining a game, players have an option to make&#xD;
        a deposit, called a &quot;financial commitment&quot; of $10-30, depending on the game. Multiple methods&#xD;
        are used to validate goal achievement. Some games require players to verify their physical&#xD;
        activity data by connecting their WayBetter app account (i.e., syncing) to a wearable device&#xD;
        or step tracking app. Other games require participants to verify their behavior by submitting&#xD;
        photos (e.g., photo from their wearable device or step tracking app showing that they met the&#xD;
        game's daily step goal; photo of meals they ate). Each game also has a social feed, where&#xD;
        users can view each other's posts and photo submissions and share anything related to their&#xD;
        fitness journey (e.g., progress, inspiration, something they are proud of). All players who&#xD;
        achieve the game's goal are declared &quot;winners.&quot; Winners who made deposits are rewarded by&#xD;
        splitting the total pot of deposits evenly, such that they earn back their original deposit&#xD;
        plus addition profit, dependent on how many users 'lost'. The app incorporates an additional&#xD;
        gamification aspect by introducing levels; players are required to win 3 games to advance a&#xD;
        level (one from each category; they can choose any games they want)&#xD;
  &#xD;
        WayBetter will send out a recruitment email to WayBetter users five days after they enter&#xD;
        into a seven-day free trial. In the email, participants will be invited to complete a study&#xD;
        survey via the Qualtrics link provided. After clicking on the link, participants will first&#xD;
        be prompted to read and respond to the study LOI. Thereafter, participants will be asked to&#xD;
        complete the survey which will aim to collect information about individual-level&#xD;
        socio-demographics (i.e., household income, rural or urban living status, gender, age, race,&#xD;
        and ethnicity), previous health behaviours (i.e., previous fitness, nutrition, stress, weight&#xD;
        loss), determinants of behavioural intentions to use health and fitness apps, and&#xD;
        behavioural/personality traits (i.e., risk taking traits, healthy behaviour self-efficacy,&#xD;
        personality traits). Participants who complete the survey will earn a $10 USD e-gift card,&#xD;
        distributed directly to participant provided email via the Tango Card rewards platform&#xD;
        (https://www.tangocard.com).&#xD;
  &#xD;
        Any games that did not utilize deposit wagers (i.e., accountability partners or no&#xD;
        motivational booster) will not be included in the analysis. Our primary outcomes are rates of&#xD;
        (a) initial six-month subscription and b) subscription renewal rates at six months, for the&#xD;
        WayBetter app. User' specific metrics, 'psychological' metrics, and app engagement&#xD;
        ('WayBetter' and 'Industry' specific) metrics of users who sign up for the 6-month&#xD;
        subscription will be used to identify underlying homogenous subgroups of individuals using&#xD;
        Latent Class Analysis (LCA). Next, we will examine associations between the subgroups (termed&#xD;
        'latent classes') to determine which users are more likely to sign-up, subscribe, and renew&#xD;
        subscription to the WayBetter app. We will use linear regressions and Cox Proportional Hazard&#xD;
        regression models to examine engagement correlates. Post Hoc analysis will be used to&#xD;
        determine between which users the statistical differences lie. The secondary objective is to&#xD;
        describe WayBetter app engagement over 24 weeks using 'WayBetter' and 'Industry' specific&#xD;
        engagement metrics. We will use descriptive statistics to summarize engagement patterns and&#xD;
        Kaplan-Meier survival curves to illustrate time to non-usage attrition and app resumption. A&#xD;
        repeated measures ANOVA will be used to demonstrate if statistically significant differences&#xD;
        exist between the user 'latent classes' and app engagement metrics. Regression equations and&#xD;
        a linear probability model will be formed to predict engagement metrics using latent classes&#xD;
        and individual-level factors (sociodemographic, previous health behaviours, determinants of&#xD;
        behavioural intentions to use health and fitness apps, and behavioural/personality traits) as&#xD;
        predictor variables. A sensitivity analysis will be completed to examine the effects of&#xD;
        methods of WayBetter account creation, 1) via the WayBetter online quiz (Group A) or 2)&#xD;
        direct download of the app on primary outcomes (Group B).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Six-month Subscription</measure>
      <time_frame>Day one of seven-day free trial [Week One] to end of seven-day free trial [End of Week One]</time_frame>
      <description>Total number of six-month WayBetter subscriptions started after a free trial</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Subscription Renewal Rates</measure>
      <time_frame>Week 24</time_frame>
      <description>Measured by number of subscription renewal rates after 6 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>App opens per week</measure>
      <time_frame>Week 1 to Week 24</time_frame>
      <description>Number of app opens for one second or longer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Date of Joining First Game</measure>
      <time_frame>Measured between Week 1 to Week 24</time_frame>
      <description>Number of days from joining free trial to joining first game</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Game Adherence</measure>
      <time_frame>Week 1 to Week 24</time_frame>
      <description>Number of verifications submitted during a game vs number of verifications required by WayBetter game</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of games started and won each week</measure>
      <time_frame>Week 1 to Week 24</time_frame>
      <description>Total number of games by (a) category (b) type (c) verification method and (d) earnings started and won each week</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-usage attrition</measure>
      <time_frame>First occurrence of four weeks of inactivity</time_frame>
      <description>Number of no app opens [one second or longer] for four weeks or longer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-engagement</measure>
      <time_frame>First occurrence of two consecutive weeks of app opens</time_frame>
      <description>First occurrence of two weeks of app resumption [one app one of one second or longer for two consecutive week]</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Physical Inactivity</condition>
    <condition>Healthy Eating</condition>
    <condition>Mental Health Wellness 1</condition>
    <arm_group>
      <arm_group_label>New users</arm_group_label>
      <description>Approximately 400 adults (≥18 years old), new to WayBetter app, who have entered into a 7-day free trial, will be studied. Each new user receives a free 1-week trial (that they need to opt into) and $10 USD deposit from WayBetter Inc. They can use the deposit for any game during trial, regardless of continuing membership. To continue to use the app, users pay $69 USD for 6 months. Each game lasts between 1-4 weeks and requires players to achieve a specific behavioural goal. Games require $10-30 deposit, chosen at signup. Validation methods vary; some sync with wearables, others submit activity photos (steps, meals). A user can join up to 10 games simultaneously. &quot;Winners&quot; of each game share deposits, gaining original deposit plus profit, based on 'losses'.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The study cohort comprises individuals who register an account on the WayBetter app and&#xD;
          successfully finish the survey within the recruitment timeframe.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          WayBetter Inc.'s users who enrolled and/or recently completed (within five days) their&#xD;
          seven-day free trial on the WayBetter app. User's are must be 18 years or older.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Users under the age of 18 are excluded to ensure that the sample represents to an adult&#xD;
          demographic. Users who are unable to communicate in English are excluded as the survey&#xD;
          necessitates completion in English.&#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>Marc Mitchell, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Western University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marc Mitchell, PhD</last_name>
      <phone>519-661-2111</phone>
      <phone_ext>87936</phone_ext>
      <email>marc.mitchell@uwo.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Erika Bloom, PhD</last_name>
      <phone>401-378-3586</phone>
      <email>erika.bloom@waybetter.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Western University, Canada</investigator_affiliation>
      <investigator_full_name>Marc Mitchell</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>mHealth</keyword>
    <keyword>behavioural economics</keyword>
    <keyword>financial incentives</keyword>
    <keyword>deposit contracts</keyword>
    <keyword>engagement</keyword>
    <keyword>physical inactivity</keyword>
    <keyword>nutrition</keyword>
    <keyword>mindfullness</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023342
  org study id: 123207
  nct id: NCT06023342
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This will be a 24-week prospective study that will incorporate user base data of WayBetter
        Inc.'s app, "WayBetter," to examine user mHealth app engagement. The primary objective of
        this study is to examine predictors (i.e., socio-demographics, past health behaviours,
        psychological determinants, app engagement metrics) of (a) initial six-month subscription and
        b) subscription renewal rates at six months for the WayBetter app. The secondary objective is
        to characterize WayBetter app engagement over the first 24 weeks of app use.
  
        Participants will be asked to complete a survey that aims to collect the information
        regarding individual-level socio-demographics, previous health behaviours, and
        behavioural/personality traits. App engagement metrics will be collected from the WayBetter
        app.
  This will be a 24-week prospective study that will incorporate user base data of WayBetter
        Inc.'s app, "WayBetter," to examine user mHealth app engagement. The primary objective of
        this study is to examine predictors (i.e., socio-demographics, past health behaviours,
        psychological determinants, app engagement metrics) of (a) initial six-month subscription and
        b) subscription renewal rates at six months for the WayBetter app. The secondary objective is
        to characterize WayBetter app engagement over the first 24 weeks of app use. Our study sample
        will consist of approximately 400 adult users (aged ≥18 years old), who are new app users
        (who have engaged in a 7-day free trial). As users may have varying registration dates, the
        data collected will only include the first 24 weeks of an individual's interaction with the
        platform.
  
        WayBetter is a wellness lifestyle mHealth app available to anyone who wants to improve their
        overall well-being. All users are asked to accept the company's privacy policy and are
        prompted to fill out personal data including (but not limited to) [email address, weight]
        when creating an account. All users are given a one-week free trial as well as $10 USD to use
        as a deposit towards any WayBetter app game, courtesy of WayBetter Inc. Users can complete
        any of the games they signed up for during their free trial, even if they decide not to
        continue to their membership. To continue to participate in games, users must subscribe to a
        six-month membership ($69 USD total). In general, users can join up to ten games at a time.
        The app has a game directory ("explore" tab) that includes 60+ games each week in three
        categories: fitness, nutrition, and mindset. New games start on Mondays, Wednesdays, and
        Fridays. Each game lasts between 1-4 weeks and requires players to achieve a specific
        behavioral goal (e.g., 5K Steps Per Day requires that they walk at least 5,000 steps per day
        on at least 4 days per week for 2 weeks). Upon joining a game, players have an option to make
        a deposit, called a "financial commitment" of $10-30, depending on the game. Multiple methods
        are used to validate goal achievement. Some games require players to verify their physical
        activity data by connecting their WayBetter app account (i.e., syncing) to a wearable device
        or step tracking app. Other games require participants to verify their behavior by submitting
        photos (e.g., photo from their wearable device or step tracking app showing that they met the
        game's daily step goal; photo of meals they ate). Each game also has a social feed, where
        users can view each other's posts and photo submissions and share anything related to their
        fitness journey (e.g., progress, inspiration, something they are proud of). All players who
        achieve the game's goal are declared "winners." Winners who made deposits are rewarded by
        splitting the total pot of deposits evenly, such that they earn back their original deposit
        plus addition profit, dependent on how many users 'lost'. The app incorporates an additional
        gamification aspect by introducing levels; players are required to win 3 games to advance a
        level (one from each category; they can choose any games they want)
  
        WayBetter will send out a recruitment email to WayBetter users five days after they enter
        into a seven-day free trial. In the email, participants will be invited to complete a study
        survey via the Qualtrics link provided. After clicking on the link, participants will first
        be prompted to read and respond to the study LOI. Thereafter, participants will be asked to
        complete the survey which will aim to collect information about individual-level
        socio-demographics (i.e., household income, rural or urban living status, gender, age, race,
        and ethnicity), previous health behaviours (i.e., previous fitness, nutrition, stress, weight
        loss), determinants of behavioural intentions to use health and fitness apps, and
        behavioural/personality traits (i.e., risk taking traits, healthy behaviour self-efficacy,
        personality traits). Participants who complete the survey will earn a $10 USD e-gift card,
        distributed directly to participant provided email via the Tango Card rewards platform
        (https://www.tangocard.com).
  
        Any games that did not utilize deposit wagers (i.e., accountability partners or no
        motivational booster) will not be included in the analysis. Our primary outcomes are rates of
        (a) initial six-month subscription and b) subscription renewal rates at six months, for the
        WayBetter app. User' specific metrics, 'psychological' metrics, and app engagement
        ('WayBetter' and 'Industry' specific) metrics of users who sign up for the 6-month
        subscription will be used to identify underlying homogenous subgroups of individuals using
        Latent Class Analysis (LCA). Next, we will examine associations between the subgroups (termed
        'latent classes') to determine which users are more likely to sign-up, subscribe, and renew
        subscription to the WayBetter app. We will use linear regressions and Cox Proportional Hazard
        regression models to examine engagement correlates. Post Hoc analysis will be used to
        determine between which users the statistical differences lie. The secondary objective is to
        describe WayBetter app engagement over 24 weeks using 'WayBetter' and 'Industry' specific
        engagement metrics. We will use descriptive statistics to summarize engagement patterns and
        Kaplan-Meier survival curves to illustrate time to non-usage attrition and app resumption. A
        repeated measures ANOVA will be used to demonstrate if statistically significant differences
        exist between the user 'latent classes' and app engagement metrics. Regression equations and
        a linear probability model will be formed to predict engagement metrics using latent classes
        and individual-level factors (sociodemographic, previous health behaviours, determinants of
        behavioural intentions to use health and fitness apps, and behavioural/personality traits) as
        predictor variables. A sensitivity analysis will be completed to examine the effects of
        methods of WayBetter account creation, 1) via the WayBetter online quiz (Group A) or 2)
        direct download of the app on primary outcomes (Group B).
  observational model: Cohort
  time perspective: Prospective
  measure: Six-month Subscription
  time frame: Day one of seven-day free trial [Week One] to end of seven-day free trial [End of Week One]
  description: Total number of six-month WayBetter subscriptions started after a free trial
  measure: Subscription Renewal Rates
  time frame: Week 24
  description: Measured by number of subscription renewal rates after 6 months
  measure: App opens per week
  time frame: Week 1 to Week 24
  description: Number of app opens for one second or longer
  measure: Date of Joining First Game
  time frame: Measured between Week 1 to Week 24
  description: Number of days from joining free trial to joining first game
  measure: Game Adherence
  time frame: Week 1 to Week 24
  description: Number of verifications submitted during a game vs number of verifications required by WayBetter game
  measure: Number of games started and won each week
  time frame: Week 1 to Week 24
  description: Total number of games by (a) category (b) type (c) verification method and (d) earnings started and won each week
  measure: Non-usage attrition
  time frame: First occurrence of four weeks of inactivity
  description: Number of no app opens [one second or longer] for four weeks or longer
  measure: Re-engagement
  time frame: First occurrence of two consecutive weeks of app opens
  description: First occurrence of two weeks of app resumption [one app one of one second or longer for two consecutive week]
  arm group label: New users
  description: Approximately 400 adults (≥18 years old), new to WayBetter app, who have entered into a 7-day free trial, will be studied. Each new user receives a free 1-week trial (that they need to opt into) and $10 USD deposit from WayBetter Inc. They can use the deposit for any game during trial, regardless of continuing membership. To continue to use the app, users pay $69 USD for 6 months. Each game lasts between 1-4 weeks and requires players to achieve a specific behavioural goal. Games require $10-30 deposit, chosen at signup. Validation methods vary; some sync with wearables, others submit activity photos (steps, meals). A user can join up to 10 games simultaneously. "Winners" of each game share deposits, gaining original deposit plus profit, based on 'losses'.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marc Mitchell, PhD
  role: Principal Investigator
  affiliation: Western University
  last name: Marc Mitchell, PhD
  phone: 519-661-2111
  phone ext: 87936
  email: marc.mitchell@uwo.ca
  last name: Erika Bloom, PhD
  phone: 401-378-3586
  email: erika.bloom@waybetter.com
  responsible party type: Principal Investigator
  investigator affiliation: Western University, Canada
  investigator full name: Marc Mitchell
  investigator title: Assistant Professor
  sharing ipd: No