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/NCT05980676</url>
    </required_header>
    <id_info>
      <org_study_id>2023-014</org_study_id>
      <nct_id>NCT05980676</nct_id>
    </id_info>
    <brief_title>Starting a Weekday Outdoor Walking (WOW) Routine</brief_title>
    <official_title>Starting a Weekday Outdoor Walking (WOW) Routine: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Edward Via Virginia College of Osteopathic Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Edward Via Virginia College of Osteopathic Medicine</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 4-week randomized study is to evaluate the effect of personalized plans&#xD;
        plus an email campaign, with and without email-based coaching (eCoaching), on engagement in a&#xD;
        new weekday outdoor walking (WOW) routine and average daily step count. Approximately 150&#xD;
        participants will be recruited via paid ads on Facebook and Instagram. Participants will be&#xD;
        randomized to a control group, an intervention group without eCoaching, and an intervention&#xD;
        group with eCoaching. The control group will be told that they can work a WOW routine on&#xD;
        their own, with the opportunity to take part in the intervention after completing the 4-week&#xD;
        follow-up assessment. Both intervention groups will complete an activity that will guide the&#xD;
        creation of habit plan (e.g., When I finish eating lunch at work, then I will put on my&#xD;
        walking shoes and go outside) and receive a 2-week long personalized email campaign. The&#xD;
        primary outcome of interest is change in average daily step count from the month prior to the&#xD;
        month after baseline assessment, as compared across the three groups. It is hypothesized that&#xD;
        the intervention groups will result in an increase in daily step count, as compared to the&#xD;
        control group. Secondary outcomes include habit strength at one-month follow-up and change in&#xD;
        self-reported sleep quality and self-efficacy from baseline to follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this 4-week randomized study is to evaluate the effect of personalized&#xD;
        implementation intentions plus an email campaign, with and without email-based coaching&#xD;
        (eCoaching), on engagement in a new weekday outdoor walking (WOW) routine and average daily&#xD;
        step count. Approximately 150 participants will be recruited via paid ads on Facebook and&#xD;
        Instagram. Participants will be randomized (1:1:1) to a control group, an intervention group&#xD;
        without eCoaching, and an intervention group with eCoaching. The control group will be told&#xD;
        that they can work a WOW routine on their own, with the opportunity to take part in the&#xD;
        intervention after completing the 4-week follow-up assessment. Both intervention groups will&#xD;
        complete an activity that will guide the creation of a habitual instigation implementation&#xD;
        intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and&#xD;
        go outside) and receive a 2-week long personalized email campaign. The primary outcome of&#xD;
        interest is change in average daily step count from the month prior to the month after&#xD;
        baseline assessment, as compared across the three groups. It is hypothesized that the&#xD;
        intervention groups will result in a statistically significant increase in daily step count,&#xD;
        as compared to the control group. Secondary outcomes include instigation habit strength (via&#xD;
        Self-Report Behavioral Automaticity Index) at one-month follow-up and change in self-reported&#xD;
        sleep quality (via the Single Items Sleep Quality Scale) and general self-efficacy (via&#xD;
        General Self-Efficacy Scale) from baseline to follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</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>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The statistician performing statistical analysis will be blinded to group assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in average daily step count</measure>
      <time_frame>Four weeks</time_frame>
      <description>Change in average daily step count from the month prior to the month after baseline assessment, as compared across the three groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Instigation habit strength</measure>
      <time_frame>Four weeks</time_frame>
      <description>Instigation habit strength measured via Self-Report Behavioral Automaticity Index at one-month follow-up. Scores range from 4-20, with a higher score indicating greater habit strength.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sleep quality</measure>
      <time_frame>Four weeks</time_frame>
      <description>Change in self-reported sleep quality, measured via the Single Items Sleep Quality Scale, from baseline to follow-up. Scores range from 0=terrible sleep to 10=excellent sleep.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in general self-efficacy</measure>
      <time_frame>Four weeks</time_frame>
      <description>Change in general self-efficacy, measured via the New General Self-Efficacy Scale from baseline to follow-up. Scores range from 8-40, with a higher score indicating higher general self-efficacy.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Physical Inactivity</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group will be told that they can work a WOW routine on their own, with the opportunity to complete the intervention after completing the 4-week follow-up assessment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No-Coach</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This is a fully automated intervention. The No-Coach group will complete an online activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. They will not be able to reply to the emails for support.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Coached</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This is a semi-automated intervention. The Coached group will complete an online activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. Prompts will be added to the end of each email such that these participants can respond to give feedback, ask questions, and receive additional support from a (human) coach.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Personalized Two-Week Email-Based Program</intervention_name>
      <description>Both intervention groups will complete an activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. The Coached group will be able to reply to the emails to give feedback, ask questions, and receive additional support.</description>
      <arm_group_label>Coached</arm_group_label>
      <arm_group_label>No-Coach</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18-55 years of age&#xD;
  &#xD;
            -  Indicates desire to increases daily step count&#xD;
  &#xD;
            -  Indicates having a safe and convenient location to conduct outdoor walks&#xD;
  &#xD;
            -  Uses an iPhone&#xD;
  &#xD;
            -  Can upload step count screenshots&#xD;
  &#xD;
            -  Intends to bring their phone on their walks&#xD;
  &#xD;
            -  Has email address that they check ~daily&#xD;
  &#xD;
            -  Has an average daily step count for month prior to enrolling &lt;5,000/day, as determined&#xD;
               by phone step data (screenshot submitted for verification).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any medical issues that could be worsened by walking. This will be assessed via the&#xD;
               Physical Activity Readiness Questionnaire (PAR-Q), minus the question asking the&#xD;
               participant if they take medication for blood pressure or a heart condition.&#xD;
               Researchers feel this question is overly cautious and would exclude many individuals&#xD;
               who would otherwise qualify and benefit from walking regularly.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joshua C Hollingsworth, PharmD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Professor at VCOM-Auburn</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joshua C Hollingsworth, PharmD, PhD</last_name>
      <phone>334-442-4041</phone>
      <email>jhollingsworth@auburn.vcom.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Edward Via College of Osteopathic Medicine-Auburn Campus (VCOM-Auburn)</name>
        <address>
          <city>Auburn</city>
          <state>Alabama</state>
          <zip>36832</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joshua C Hollingsworth, PharmD, PhD</last_name>
        <phone>228-623-8106</phone>
        <email>jhollingsworth@auburn.vcom.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Behavioral health</keyword>
    <keyword>Health behavior change</keyword>
    <keyword>Habit formation</keyword>
    <keyword>Implementation intentions</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/NCT05980676
  org study id: 2023-014
  nct id: NCT05980676
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this 4-week randomized study is to evaluate the effect of personalized plans
        plus an email campaign, with and without email-based coaching (eCoaching), on engagement in a
        new weekday outdoor walking (WOW) routine and average daily step count. Approximately 150
        participants will be recruited via paid ads on Facebook and Instagram. Participants will be
        randomized to a control group, an intervention group without eCoaching, and an intervention
        group with eCoaching. The control group will be told that they can work a WOW routine on
        their own, with the opportunity to take part in the intervention after completing the 4-week
        follow-up assessment. Both intervention groups will complete an activity that will guide the
        creation of habit plan (e.g., When I finish eating lunch at work, then I will put on my
        walking shoes and go outside) and receive a 2-week long personalized email campaign. The
        primary outcome of interest is change in average daily step count from the month prior to the
        month after baseline assessment, as compared across the three groups. It is hypothesized that
        the intervention groups will result in an increase in daily step count, as compared to the
        control group. Secondary outcomes include habit strength at one-month follow-up and change in
        self-reported sleep quality and self-efficacy from baseline to follow-up.
  The purpose of this 4-week randomized study is to evaluate the effect of personalized
        implementation intentions plus an email campaign, with and without email-based coaching
        (eCoaching), on engagement in a new weekday outdoor walking (WOW) routine and average daily
        step count. Approximately 150 participants will be recruited via paid ads on Facebook and
        Instagram. Participants will be randomized (1:1:1) to a control group, an intervention group
        without eCoaching, and an intervention group with eCoaching. The control group will be told
        that they can work a WOW routine on their own, with the opportunity to take part in the
        intervention after completing the 4-week follow-up assessment. Both intervention groups will
        complete an activity that will guide the creation of a habitual instigation implementation
        intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and
        go outside) and receive a 2-week long personalized email campaign. The primary outcome of
        interest is change in average daily step count from the month prior to the month after
        baseline assessment, as compared across the three groups. It is hypothesized that the
        intervention groups will result in a statistically significant increase in daily step count,
        as compared to the control group. Secondary outcomes include instigation habit strength (via
        Self-Report Behavioral Automaticity Index) at one-month follow-up and change in self-reported
        sleep quality (via the Single Items Sleep Quality Scale) and general self-efficacy (via
        General Self-Efficacy Scale) from baseline to follow-up.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  masking description: The statistician performing statistical analysis will be blinded to group assignment.
  measure: Change in average daily step count
  time frame: Four weeks
  description: Change in average daily step count from the month prior to the month after baseline assessment, as compared across the three groups.
  measure: Instigation habit strength
  time frame: Four weeks
  description: Instigation habit strength measured via Self-Report Behavioral Automaticity Index at one-month follow-up. Scores range from 4-20, with a higher score indicating greater habit strength.
  measure: Change in sleep quality
  time frame: Four weeks
  description: Change in self-reported sleep quality, measured via the Single Items Sleep Quality Scale, from baseline to follow-up. Scores range from 0=terrible sleep to 10=excellent sleep.
  measure: Change in general self-efficacy
  time frame: Four weeks
  description: Change in general self-efficacy, measured via the New General Self-Efficacy Scale from baseline to follow-up. Scores range from 8-40, with a higher score indicating higher general self-efficacy.
  arm group label: Control
  arm group type: No Intervention
  description: The control group will be told that they can work a WOW routine on their own, with the opportunity to complete the intervention after completing the 4-week follow-up assessment.
  arm group label: No-Coach
  arm group type: Experimental
  description: This is a fully automated intervention. The No-Coach group will complete an online activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. They will not be able to reply to the emails for support.
  arm group label: Coached
  arm group type: Experimental
  description: This is a semi-automated intervention. The Coached group will complete an online activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. Prompts will be added to the end of each email such that these participants can respond to give feedback, ask questions, and receive additional support from a (human) coach.
  intervention type: Behavioral
  intervention name: Personalized Two-Week Email-Based Program
  description: Both intervention groups will complete an activity that will guide the creation of a habitual instigation implementation intention (e.g., When I finish eating lunch at work, then I will put on my walking shoes and go outside) and receive a 2-week long personalized email campaign. The Coached group will be able to reply to the emails to give feedback, ask questions, and receive additional support.
  arm group label: Coached
  arm group label: No-Coach
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joshua C Hollingsworth, PharmD, PhD
  role: Principal Investigator
  affiliation: Assistant Professor at VCOM-Auburn
  last name: Joshua C Hollingsworth, PharmD, PhD
  phone: 334-442-4041
  email: jhollingsworth@auburn.vcom.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No