<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/NCT02972515</url>
  </required_header>
  <id_info>
    <org_study_id>1R21CA174639</org_study_id>
    <secondary_id>1R21CA174639</secondary_id>
    <nct_id>NCT02972515</nct_id>
  </id_info>
  <brief_title>Mobile Application for Guided Imagery to Address Smoking, Diet and Physical Activity</brief_title>
  <acronym>Imagery</acronym>
  <official_title>Mobile Application for Guided Imagery to Address Smoking, Diet and Physical Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tobacco use among women now approaches that of men, with approximately 27 million women&#xD;
      smokers in the United States alone. Women report greater difficulties quitting smoking and&#xD;
      are more likely to relapse than men. In addition, tobacco use co-varies with poor dietary&#xD;
      practices and lack of physical activity, with 92% of smokers reporting at least one other&#xD;
      health risk factor. Concerns surrounding weight gain, negative body image, and low&#xD;
      self-efficacy, may be key factors affecting smoking cessation among weight-concerned women&#xD;
      smokers. Guided imagery has been successfully employed in separate lines of inquiry to&#xD;
      address physical activity, diet and smoking cessation. However, guided imagery has not been&#xD;
      employed to target weight concerned women who smoke or to simultaneously target smoking,&#xD;
      diet, and exercise behavior in a single intervention. The proposed study would be the first&#xD;
      of its kind to create a theory-based, guided imagery intervention to assist weight-concerned&#xD;
      women smokers to quit. The use of a mobile app offers an innovative approach to addressing&#xD;
      the multiple behaviors involved in smoking cessation efforts of weight-concerned women, and&#xD;
      has the potential to reach large numbers of women smokers. The project aims to develop and&#xD;
      test the feasibility of a mobile health application using guided imagery in order to increase&#xD;
      smoking cessation among a population of weight-concerned women smokers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SPECIFIC AIMS Tobacco use among women now approaches that of men, with approximately 27&#xD;
      million women smokers in the United States alone. Lung cancer is the leading cause of cancer&#xD;
      death among women, and more than 180,000 women die of other illnesses linked to smoking&#xD;
      annually. Women report greater difficulties quitting smoking and are more likely to relapse&#xD;
      than men. In addition, tobacco use co-varies with poor dietary practices and lack of physical&#xD;
      activity, with 92% of smokers reporting at least one other health risk factor. The presence&#xD;
      of multiple behavioral risk factors greatly increases the risk of developing many acute and&#xD;
      chronic conditions.&#xD;
&#xD;
      Concerns about weight gain, negative body image, and lack of self-efficacy may be key factors&#xD;
      affecting smoking, diet, and exercise behavior of women. Women smokers are less satisfied&#xD;
      with their bodies, have lower self-esteem, and are more concerned about becoming overweight&#xD;
      than non-smokers. Approximately 50% of women smokers report that concerns about body weight&#xD;
      are reasons they do not quit. Research indicates that women report lower self-efficacy in&#xD;
      quitting than men, especially women concerned about controlling their weight. These findings&#xD;
      suggest that targeting weight concerns, body image, and self-efficacy to quit with&#xD;
      weight-concerned women who smoke may be an effective intervention strategy. Recent studies&#xD;
      suggest that a multi-behavioral approach, including diet and physical activity, may be more&#xD;
      effective at helping weight-concerned smokers to quit.&#xD;
&#xD;
      One cognitive approach, guided imagery, has been successfully employed in separate lines of&#xD;
      inquiry to address body image concerns and self-efficacy in our three target&#xD;
      behaviors-exercise, diet and smoking cessation. However, guided imagery has not been employed&#xD;
      to target weight concerned women who smoke or to simultaneously target smoking, diet, and&#xD;
      exercise behavior in a single intervention. The proposed study would be the first of its kind&#xD;
      to create a theory-based, guided imagery intervention to assist weight-concerned women&#xD;
      smokers to quit.&#xD;
&#xD;
      While imagery is an effective therapeutic tool for behavior change, the mode of delivery has&#xD;
      generally been in-person, limiting the dissemination of guided imagery-based interventions to&#xD;
      large populations. Mobile health applications (mobile apps) delivered via smart phones offer&#xD;
      a unique channel through which to distribute imagery-based interventions. Mobile apps may&#xD;
      enhance the use of guided imagery through the use of audio files. The app may allow guided&#xD;
      imagery scripts to be tailored by the user, and flexibly administered at varying times (e.g.,&#xD;
      during nicotine cravings). This approach could be especially useful for women, who are more&#xD;
      likely than men to use the Internet to obtain health information. The use of a mobile app&#xD;
      offers an innovative approach to addressing the multiple behaviors involved in smoking&#xD;
      cessation efforts of weight-concerned women, and has the potential to reach large numbers of&#xD;
      women smokers. If successful, a mobile application for guided imagery could be used to&#xD;
      address other health behaviors as well. The present project aims to develop and test the&#xD;
      feasibility of a mobile health application using guided imagery in order to increase smoking&#xD;
      cessation among weight-concerned women smokers.&#xD;
&#xD;
      The Specific Aims for this study are to:&#xD;
&#xD;
      Aim 1. Develop guided imagery content, user interface, and resources to reduce weight&#xD;
      concern, and increase body image and self-efficacy for behavior change among weight-concerned&#xD;
      women smokers. Scripts incorporating imagery across these domains will be developed&#xD;
      specifically for smoking cessation, eating a healthy diet and engaging in physical activity.&#xD;
      The investigators will develop initial content and user interface ideas based on experience&#xD;
      in using guided imagery for increasing physical activity, and using technology to assist&#xD;
      tobacco cessation and healthy eating. Ten focus group participants (weight-concerned women&#xD;
      smokers who own a smart phone, representing various racial/ethnic groups) will provide&#xD;
      feedback on content, potential tailoring of content by race/ethnicity, functions, and design,&#xD;
      which will inform development of the mobile app.&#xD;
&#xD;
      Aim 2. Program a prototype of the app that contains all the necessary elements of text,&#xD;
      graphics, multimedia and interactive features. Users will be able to customize certain&#xD;
      elements of the application, and be required to provide input in response to app prompts. The&#xD;
      investigators will conduct usability testing, observing 10 participants using &quot;think aloud&quot;&#xD;
      procedures as they interact with the app, to ensure that it is fully functional and easy to&#xD;
      use.&#xD;
&#xD;
      Aim 3. Evaluate the feasibility, acceptability, and preliminary efficacy of the app with 50&#xD;
      weight-concerned women smokers. The primary outcome will be self-reported tobacco abstinence&#xD;
      at 3 months post-enrollment. The investigators will also measure: dietary intake; level of&#xD;
      physical activity; body image; self-efficacy; cravings; and participants' use of the app,&#xD;
      including the imagery scripts, diary, and resource links.&#xD;
&#xD;
      The potential impact of this proposed intervention is great, because it addresses behavioral&#xD;
      risk factors that can be applied to populations beyond smokers. This proposal is significant&#xD;
      because it intervenes with women smokers; innovative, in that it uses guided imagery to&#xD;
      change lifestyle behaviors important for the prevention of chronic diseases, and, technology&#xD;
      to maximize dissemination potential. The proposed investigation takes a theory-based&#xD;
      approach, builds on the considerable track records of the investigators, and will be&#xD;
      conducted in an environment highly suited for this study. Results of this study will be used&#xD;
      to prepare for a future randomized controlled trial to test the efficacy and&#xD;
      cost-effectiveness of a multi-behavioral, guided imagery mobile health application versus a&#xD;
      single smoking cessation imagery mobile health application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting Smoking Abstinence</measure>
    <time_frame>3 months</time_frame>
    <description>Self-reported smoking abstinence will be collected via online questionnaire at 3-months post-enrollment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weekly Minutes of Exercise</measure>
    <time_frame>3 months</time_frame>
    <description>Self-reported level of moderate to strenuous physical activity will be collected via online questionnaire at 3-months post-enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Servings of Fruit Per Day</measure>
    <time_frame>3 months</time_frame>
    <description>Self-reported consumption of servings of fruits per day will be collected via online questionnaire at 3-months post-enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minutes of Guided Imagery Use Per Day</measure>
    <time_frame>Collected throughout each day for up to 90 days</time_frame>
    <description>Interaction with the mHealth app will be measured automatically and unobtrusively by the app on an on-going basis. The app will collect the number of minutes per day that the guided imagery audio files are listened to.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>See Me Smoke-Free</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received access to the See Me Smoke-Free mobile application (app) delivered via smart phone, and were asked to use the app &quot;most days&quot; for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>See Me Smoke-Free</intervention_name>
    <description>See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.</description>
    <arm_group_label>See Me Smoke-Free</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Smart phone</intervention_name>
    <description>See Me Smoke-Free mHealth app delivered via a smart phone</description>
    <arm_group_label>See Me Smoke-Free</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria include the following:&#xD;
&#xD;
          -  Must be female&#xD;
&#xD;
          -  Report smoking in the past 30 days&#xD;
&#xD;
          -  Use an Android cell phone&#xD;
&#xD;
          -  Have a valid email address&#xD;
&#xD;
          -  Have a valid phone number&#xD;
&#xD;
          -  Speak English&#xD;
&#xD;
        Exclusion Criteria including the following:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Not a current smoker&#xD;
&#xD;
          -  Do not use an Android cell phone&#xD;
&#xD;
          -  Do not have a valid email address&#xD;
&#xD;
          -  Do not have a valid phone number&#xD;
&#xD;
          -  Do not speak English&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Judith Gordon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <reference>
    <citation>Giacobbi P Jr, Hingle M, Johnson T, Cunningham JK, Armin J, Gordon JS. See Me Smoke-Free: Protocol for a Research Study to Develop and Test the Feasibility of an mHealth App for Women to Address Smoking, Diet, and Physical Activity. JMIR Res Protoc. 2016 Jan 21;5(1):e12. doi: 10.2196/resprot.5126.</citation>
    <PMID>26795257</PMID>
  </reference>
  <reference>
    <citation>Armin J, Johnson T, Hingle M, Giacobbi P Jr, Gordon JS. Development of a Multi-Behavioral mHealth App for Women Smokers. J Health Commun. 2017 Feb;22(2):153-162. doi: 10.1080/10810730.2016.1256454. Epub 2017 Jan 25.</citation>
    <PMID>28121240</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>October 9, 2018</results_first_submitted>
  <results_first_submitted_qc>November 27, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 19, 2018</results_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">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>Smoking cessation</keyword>
  <keyword>Multiple behaviors</keyword>
  <keyword>mHealth</keyword>
  <keyword>Mobile Application</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>See Me Smoke-Free</title>
          <description>Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app &quot;most days&quot; for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.&#xD;
See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.&#xD;
Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="166"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Data reported for 73 participants who completed the feasibility trial. These data do not include participants from the formative phase of the study or those lost to follow-up.</population>
      <group_list>
        <group group_id="B1">
          <title>See Me Smoke-Free</title>
          <description>Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app &quot;most days&quot; for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.&#xD;
See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.&#xD;
Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="73"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.1" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoked last 30 days</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarettes per day</title>
          <units>Cigarettes per Day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.0" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169.8" spread="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Frequency of fruit intake</title>
          <units>servings of fruit per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.70" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Minutes of Exercise per Day</title>
          <units>Minutes of exercise per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.48" spread="23.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Use of any guided imagery</title>
          <units>minutes of any guided imagery daily</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.77" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Smoking Abstinence</title>
        <description>Self-reported smoking abstinence will be collected via online questionnaire at 3-months post-enrollment.</description>
        <time_frame>3 months</time_frame>
        <population>63 feasibility participants with both baseline and 3-month data.</population>
        <group_list>
          <group group_id="O1">
            <title>See Me Smoke-Free</title>
            <description>Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app &quot;most days&quot; for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.&#xD;
See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.&#xD;
Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Smoking Abstinence</title>
          <description>Self-reported smoking abstinence will be collected via online questionnaire at 3-months post-enrollment.</description>
          <population>63 feasibility participants with both baseline and 3-month data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weekly Minutes of Exercise</title>
        <description>Self-reported level of moderate to strenuous physical activity will be collected via online questionnaire at 3-months post-enrollment.</description>
        <time_frame>3 months</time_frame>
        <population>Data analyzed on 60 feasibility participants with both baseline and 3-month data.</population>
        <group_list>
          <group group_id="O1">
            <title>See Me Smoke-Free</title>
            <description>Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app &quot;most days&quot; for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.&#xD;
See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.&#xD;
Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone</description>
          </group>
        </group_list>
        <measure>
          <title>Weekly Minutes of Exercise</title>
          <description>Self-reported level of moderate to strenuous physical activity will be collected via online questionnaire at 3-months post-enrollment.</description>
          <population>Data analyzed on 60 feasibility participants with both baseline and 3-month data.</population>
          <units>minutes of exercise per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="269" spread="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Servings of Fruit Per Day</title>
        <description>Self-reported consumption of servings of fruits per day will be collected via online questionnaire at 3-months post-enrollment.</description>
        <time_frame>3 months</time_frame>
        <population>62 feasibility participants with data from both baseline and follow-up</population>
        <group_list>
          <group group_id="O1">
            <title>See Me Smoke-Free</title>
            <description>Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app &quot;most days&quot; for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.&#xD;
See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.&#xD;
Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone</description>
          </group>
        </group_list>
        <measure>
          <title>Servings of Fruit Per Day</title>
          <description>Self-reported consumption of servings of fruits per day will be collected via online questionnaire at 3-months post-enrollment.</description>
          <population>62 feasibility participants with data from both baseline and follow-up</population>
          <units>servings of fruit per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minutes of Guided Imagery Use Per Day</title>
        <description>Interaction with the mHealth app will be measured automatically and unobtrusively by the app on an on-going basis. The app will collect the number of minutes per day that the guided imagery audio files are listened to.</description>
        <time_frame>Collected throughout each day for up to 90 days</time_frame>
        <population>62 feasibility participant with both baseline and 3-month data.</population>
        <group_list>
          <group group_id="O1">
            <title>See Me Smoke-Free</title>
            <description>Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app &quot;most days&quot; for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.&#xD;
See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.&#xD;
Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone</description>
          </group>
        </group_list>
        <measure>
          <title>Minutes of Guided Imagery Use Per Day</title>
          <description>Interaction with the mHealth app will be measured automatically and unobtrusively by the app on an on-going basis. The app will collect the number of minutes per day that the guided imagery audio files are listened to.</description>
          <population>62 feasibility participant with both baseline and 3-month data.</population>
          <units>minutes of guided imagery user per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>This was an exempt study. There was no risk of mortality or serious adverse events as a result of this behavioral smoking cessation intervention.</desc>
      <group_list>
        <group group_id="E1">
          <title>See Me Smoke-Free</title>
          <description>Participants received access to the See Me Smoke-Free mobile application (app), and were asked to use the app &quot;most days&quot; for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.&#xD;
See Me Smoke-Free: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.&#xD;
Smart phone: See Me Smoke-Free mHealth app delivered via a smart phone</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Judith Gordon</name_or_title>
      <organization>University of Arizona</organization>
      <phone>520-626-4970</phone>
      <email>judithg@email.arizona.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02972515
org study id: 1R21CA174639
secondary id: 1R21CA174639
nct id: NCT02972515
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Tobacco use among women now approaches that of men, with approximately 27 million women
      smokers in the United States alone. Women report greater difficulties quitting smoking and
      are more likely to relapse than men. In addition, tobacco use co-varies with poor dietary
      practices and lack of physical activity, with 92% of smokers reporting at least one other
      health risk factor. Concerns surrounding weight gain, negative body image, and low
      self-efficacy, may be key factors affecting smoking cessation among weight-concerned women
      smokers. Guided imagery has been successfully employed in separate lines of inquiry to
      address physical activity, diet and smoking cessation. However, guided imagery has not been
      employed to target weight concerned women who smoke or to simultaneously target smoking,
      diet, and exercise behavior in a single intervention. The proposed study would be the first
      of its kind to create a theory-based, guided imagery intervention to assist weight-concerned
      women smokers to quit. The use of a mobile app offers an innovative approach to addressing
      the multiple behaviors involved in smoking cessation efforts of weight-concerned women, and
      has the potential to reach large numbers of women smokers. The project aims to develop and
      test the feasibility of a mobile health application using guided imagery in order to increase
      smoking cessation among a population of weight-concerned women smokers.
SPECIFIC AIMS Tobacco use among women now approaches that of men, with approximately 27
      million women smokers in the United States alone. Lung cancer is the leading cause of cancer
      death among women, and more than 180,000 women die of other illnesses linked to smoking
      annually. Women report greater difficulties quitting smoking and are more likely to relapse
      than men. In addition, tobacco use co-varies with poor dietary practices and lack of physical
      activity, with 92% of smokers reporting at least one other health risk factor. The presence
      of multiple behavioral risk factors greatly increases the risk of developing many acute and
      chronic conditions.

      Concerns about weight gain, negative body image, and lack of self-efficacy may be key factors
      affecting smoking, diet, and exercise behavior of women. Women smokers are less satisfied
      with their bodies, have lower self-esteem, and are more concerned about becoming overweight
      than non-smokers. Approximately 50% of women smokers report that concerns about body weight
      are reasons they do not quit. Research indicates that women report lower self-efficacy in
      quitting than men, especially women concerned about controlling their weight. These findings
      suggest that targeting weight concerns, body image, and self-efficacy to quit with
      weight-concerned women who smoke may be an effective intervention strategy. Recent studies
      suggest that a multi-behavioral approach, including diet and physical activity, may be more
      effective at helping weight-concerned smokers to quit.

      One cognitive approach, guided imagery, has been successfully employed in separate lines of
      inquiry to address body image concerns and self-efficacy in our three target
      behaviors-exercise, diet and smoking cessation. However, guided imagery has not been employed
      to target weight concerned women who smoke or to simultaneously target smoking, diet, and
      exercise behavior in a single intervention. The proposed study would be the first of its kind
      to create a theory-based, guided imagery intervention to assist weight-concerned women
      smokers to quit.

      While imagery is an effective therapeutic tool for behavior change, the mode of delivery has
      generally been in-person, limiting the dissemination of guided imagery-based interventions to
      large populations. Mobile health applications (mobile apps) delivered via smart phones offer
      a unique channel through which to distribute imagery-based interventions. Mobile apps may
      enhance the use of guided imagery through the use of audio files. The app may allow guided
      imagery scripts to be tailored by the user, and flexibly administered at varying times (e.g.,
      during nicotine cravings). This approach could be especially useful for women, who are more
      likely than men to use the Internet to obtain health information. The use of a mobile app
      offers an innovative approach to addressing the multiple behaviors involved in smoking
      cessation efforts of weight-concerned women, and has the potential to reach large numbers of
      women smokers. If successful, a mobile application for guided imagery could be used to
      address other health behaviors as well. The present project aims to develop and test the
      feasibility of a mobile health application using guided imagery in order to increase smoking
      cessation among weight-concerned women smokers.

      The Specific Aims for this study are to:

      Aim 1. Develop guided imagery content, user interface, and resources to reduce weight
      concern, and increase body image and self-efficacy for behavior change among weight-concerned
      women smokers. Scripts incorporating imagery across these domains will be developed
      specifically for smoking cessation, eating a healthy diet and engaging in physical activity.
      The investigators will develop initial content and user interface ideas based on experience
      in using guided imagery for increasing physical activity, and using technology to assist
      tobacco cessation and healthy eating. Ten focus group participants (weight-concerned women
      smokers who own a smart phone, representing various racial/ethnic groups) will provide
      feedback on content, potential tailoring of content by race/ethnicity, functions, and design,
      which will inform development of the mobile app.

      Aim 2. Program a prototype of the app that contains all the necessary elements of text,
      graphics, multimedia and interactive features. Users will be able to customize certain
      elements of the application, and be required to provide input in response to app prompts. The
      investigators will conduct usability testing, observing 10 participants using "think aloud"
      procedures as they interact with the app, to ensure that it is fully functional and easy to
      use.

      Aim 3. Evaluate the feasibility, acceptability, and preliminary efficacy of the app with 50
      weight-concerned women smokers. The primary outcome will be self-reported tobacco abstinence
      at 3 months post-enrollment. The investigators will also measure: dietary intake; level of
      physical activity; body image; self-efficacy; cravings; and participants' use of the app,
      including the imagery scripts, diary, and resource links.

      The potential impact of this proposed intervention is great, because it addresses behavioral
      risk factors that can be applied to populations beyond smokers. This proposal is significant
      because it intervenes with women smokers; innovative, in that it uses guided imagery to
      change lifestyle behaviors important for the prevention of chronic diseases, and, technology
      to maximize dissemination potential. The proposed investigation takes a theory-based
      approach, builds on the considerable track records of the investigators, and will be
      conducted in an environment highly suited for this study. Results of this study will be used
      to prepare for a future randomized controlled trial to test the efficacy and
      cost-effectiveness of a multi-behavioral, guided imagery mobile health application versus a
      single smoking cessation imagery mobile health application.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Reporting Smoking Abstinence
time frame: 3 months
description: Self-reported smoking abstinence will be collected via online questionnaire at 3-months post-enrollment.
measure: Weekly Minutes of Exercise
time frame: 3 months
description: Self-reported level of moderate to strenuous physical activity will be collected via online questionnaire at 3-months post-enrollment.
measure: Servings of Fruit Per Day
time frame: 3 months
description: Self-reported consumption of servings of fruits per day will be collected via online questionnaire at 3-months post-enrollment.
measure: Minutes of Guided Imagery Use Per Day
time frame: Collected throughout each day for up to 90 days
description: Interaction with the mHealth app will be measured automatically and unobtrusively by the app on an on-going basis. The app will collect the number of minutes per day that the guided imagery audio files are listened to.
arm group label: See Me Smoke-Free
arm group type: Experimental
description: Participants received access to the See Me Smoke-Free mobile application (app) delivered via smart phone, and were asked to use the app "most days" for 30 days post-enrollment. The app contained five guided imagery audio files (Introduction to Guided Imagery, Be Smoke Free, Eat Well, Get Active, and Feel Fantastic), a tracking calendar, awards, resources, reminders, and tips and techniques.
intervention type: Behavioral
intervention name: See Me Smoke-Free
description: See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.
arm group label: See Me Smoke-Free
intervention type: Device
intervention name: Smart phone
description: See Me Smoke-Free mHealth app delivered via a smart phone
arm group label: See Me Smoke-Free
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Judith Gordon, PhD
role: Principal Investigator
affiliation: University of Arizona
citation: Giacobbi P Jr, Hingle M, Johnson T, Cunningham JK, Armin J, Gordon JS. See Me Smoke-Free: Protocol for a Research Study to Develop and Test the Feasibility of an mHealth App for Women to Address Smoking, Diet, and Physical Activity. JMIR Res Protoc. 2016 Jan 21;5(1):e12. doi: 10.2196/resprot.5126.
PMID: 26795257
citation: Armin J, Johnson T, Hingle M, Giacobbi P Jr, Gordon JS. Development of a Multi-Behavioral mHealth App for Women Smokers. J Health Commun. 2017 Feb;22(2):153-162. doi: 10.1080/10810730.2016.1256454. Epub 2017 Jan 25.
PMID: 28121240
responsible party type: Sponsor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 