<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/NCT03235713</url>
  </required_header>
  <id_info>
    <org_study_id>HKTC-EMA</org_study_id>
    <nct_id>NCT03235713</nct_id>
  </id_info>
  <brief_title>EMA for Tobacco Control Policy Research</brief_title>
  <official_title>Ecological Momentary Assessments for the Evaluation of Tobacco Health Warnings, Point-of-sale Tobacco Displays and Smoking Hotspots: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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 study aims to (1) evaluate the effectiveness of the recent renewal of tobacco health&#xD;
      warnings (HWs) on noticing and anti-smoking responses, and (2) assess the effect of exposure&#xD;
      to point-of-sale (POS) tobacco displays and smoking hotspots on nicotine-craving intensity&#xD;
      and smoking-related behaviors. The study will use time-based system-triggered ecological&#xD;
      momentary assessments to collect real-time data about exposures to smoking-related cues and&#xD;
      behaviors. With a smartphone app installed in the mobile phones of the participants, they&#xD;
      will each day complete at least 3 pairs of EMA prompted randomly for only 2 days (a working&#xD;
      and a nonworking day). Outcomes include exposure and responses to tobacco HWs, exposure to&#xD;
      POS tobacco displays, exposure to smoking hotspots and smoking and quitting outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Study Design The proposed study is a time-based system-triggered EMA which will collect&#xD;
           real-time data about exposures to smoking-related cues and behaviors. With a smartphone&#xD;
           app installed in the mobile phones of the participants, they will each day complete at&#xD;
           least 3 pairs of EMA prompted randomly for only 2 days (a working and a non-working&#xD;
           day). The prompting time will be sampled from the time when the participants are&#xD;
           outdoor, so that more exposures to the tobacco HW, POS tobacco displays, and smoking&#xD;
           hotspots can be captured. The EMA includes questions of the self-reported exposure to&#xD;
           and/or responses to tobacco HWs, POS tobacco displays, smoking hotspots, craving&#xD;
           intensity, and other smoking-related outcomes.&#xD;
&#xD;
        2. Procedures The clinic counselors will briefly introduce all the clients in the clinics&#xD;
           about the study during their visits. The clients who are interested will be referred to&#xD;
           the on-site recruitment staff to screen for the eligibility. In the setting of retail&#xD;
           shops and smoking hotspots, the recruitment staff will proactively approach the smokers.&#xD;
           Eligible participants will be given more details of the study and invited to give a&#xD;
           written consent for participation. Then, they will complete a baseline questionnaire&#xD;
           administered by the recruitment staff. Afterwards, the staff will assist the&#xD;
           participants to install the EMA app in their mobile phones, and ask the participants to&#xD;
           select one working day and one non-working day, and then select at least 3 time windows&#xD;
           for the EMA on each study day. These time windows can be their outdoor time when they&#xD;
           are more likely to be exposed to the smoking-related locations, such as traveling to&#xD;
           work, lunch time, or shopping. Then, the staff will set up the EMA schedule in the app&#xD;
           for the participants, and train the participants to answer the questionnaire. A&#xD;
           pocket-sized instruction card of using the app will be provided. The EMA will not&#xD;
           interfere the smoking cessation intervention they receive in the clinic.&#xD;
&#xD;
      To protect the privacy of the participants, several strategies will be adopted. First,&#xD;
      participants will be reassured that all data are anonymous in the data collection and the&#xD;
      analysis. All data will not be accessed by the clinic counselors. Second, no personal data&#xD;
      (e.g. name and telephone numbers) will be collected in the app.&#xD;
&#xD;
      The EMA validity largely relies on the participants' compliance, therefore an attractive&#xD;
      incentive is needed. If they complete all the EMAs in the 2-day period, they will be given&#xD;
      HK$200 dollar.&#xD;
&#xD;
      After the data collection, the participants will be reminded to uninstall the app. They will&#xD;
      be contacted to receive the incentive and complete the last questionnaire face-to-face.&#xD;
&#xD;
      3 . EMA app The EMA app will be developed based on the app used in our aforementioned pilot&#xD;
      randomized trial, which has a user-friendly interface and is easily operated. Users need to&#xD;
      input at least 3 time windows (each for at least an hour) in each study day. In each time&#xD;
      window, the app will firstly prompt the user at a random time to answer a set of&#xD;
      questionnaire in the app, including questions on (1) exposure and responses to tobacco HW,&#xD;
      (2) exposure to tobacco POS displays, (3) exposure to smoking hotspots, and (4) smoking and&#xD;
      quitting outcomes. After 30 minutes of completing the first questionnaire, the app will&#xD;
      prompt again the user to answer another set of questionnaire, which only assess smoking and&#xD;
      quitting outcomes. The design of EMA pair within 30 minutes facilitates the analysis of&#xD;
      causality, because we can capture some smoking or cravings preceded by the environmental&#xD;
      exposures. Each questionnaire will take no more than 1 minute to complete. If an EMA prompt&#xD;
      is not responded by the user, 2 additional prompts in every 5 minutes will be generated to&#xD;
      remind the user to complete. The EMA will regard non-response as missing data if these&#xD;
      additional prompts are not responded. All the above data will be sent to our server in each&#xD;
      day.&#xD;
&#xD;
      4. Statistical analysis Data will be analyzed with SPSS or Stata for Windows. The first&#xD;
      research question can be addressed by comparing the frequency/proportion of the 4 HW-related&#xD;
      outcomes pre- and post-implementation of the new warnings. To take into account the&#xD;
      clustering between the outcomes within each participant, generalized estimating equation&#xD;
      model will be used to assess the effect of new HWs on the noticing and responses to the HWs.&#xD;
      To answer the second and third research questions, each EMA pair is the analysis unit, which&#xD;
      is nested within each participant. The 3 outcome variables include the craving intensity&#xD;
      (continuous variable), purchase of tobacco (binary) and smoking (binary). In the main&#xD;
      analysis, linear mixed model (continuous) and mixed logistic regression model (binary) which&#xD;
      allow for multiple observations in each subjects and account for clustering of data within&#xD;
      subjects will be used to explore the association between each exposure variable and the&#xD;
      outcome variables, adjusted for the variables collected at baseline. Significance level will&#xD;
      be defined as p&lt;0.05.&#xD;
&#xD;
      5. Consent Participation in the study is voluntary. The recruitment staff will explain to the&#xD;
      potential subjects who agree to join the study, before the written consent is requested. The&#xD;
      subjects will be assured that they can withdraw from the study anytime without any prejudice,&#xD;
      and all the information will be kept confidential and results will be reported in an&#xD;
      aggregate format. Subjects are required to sign the written consent form.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Exposure and responses to tobacco HWs</measure>
    <time_frame>2 hours</time_frame>
    <description>The question set includes (1) whether he/she has noticed tobacco HWs in the past 2 hours (yes/no), (2) whether he/she has thought of the harms of smoking due to the HWs (yes/no), (3) whether he/she has thought of quitting due to the HWs (yes/no), and (4) whether he/she has forgone cigarettes due to PWs (yes/no). All items will be re-assessed in the later waves of EMA data collection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exposure to POS tobacco displays</measure>
    <time_frame>2 hours</time_frame>
    <description>The question set includes (1) whether he/she has entered into any retail shops selling tobacco in the past hour (e.g. 7-11, OK) (yes/no), (2) if he/she has noticed tobacco POS displays in those retail shops in the past 2 hours (yes/no), and (3) in what extent he/she perceive the displays as attractive (5-point scale).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Exposure to smoking hotspots</measure>
    <time_frame>2 hours</time_frame>
    <description>The question set includes (1) whether he/she has witnessed a group of smokers (at least 3 smokers) smoking at one specific outdoor area nearby a rubbish bin in the past 2 hours (yes/no), (2) if yes, whether he/she was within 3 meters of such &quot;cluster&quot; of smokers and (3) whether he/she has smoked at these places in the past hour (yes/no).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking and quitting outcomes</measure>
    <time_frame>half an hour</time_frame>
    <description>The question set includes (1) the craving intensity in the past half hour (no craving, mild, fair, heavy, very heavy), (2) whether he/she has bought tobacco in the past half hour (yes/no), (3) whether he/she has smoked in past half hour (yes/no) and (4) whether the above responses have been due to the exposure to POS tobacco displays and/or smoking hotspots.</description>
  </primary_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>Tobacco Use</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study targets to recruit 300 smokers, who will be from smoking cessation clinic (150),&#xD;
        outside the retail shops selling tobacco (75), and smoking hotspots (75). All smoking&#xD;
        cessation clinics under Tung Wah Group of Hospitals, Pok Oi Hospitals and Hospital&#xD;
        Authority will be included. The recruited smokers in these clinics are ready to quit, which&#xD;
        are more responsive to cue-induced cravings than other smokers. Smokers who are less ready&#xD;
        to quit will be recruited from retail shops and smoking hotspots. These sites will be&#xD;
        carefully selected for better recruitment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. daily smoker before enrolment in the clinics,&#xD;
&#xD;
          2. aged 18 years or older,&#xD;
&#xD;
          3. had a mobile phone,&#xD;
&#xD;
          4. his/her mobile phone can access the Internet,&#xD;
&#xD;
          5. he/she has no plan to travel overseas in the coming week.&#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>Derek Derek</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tung Wah Group of Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <zip>00</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ecological momentary assessments</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03235713
org study id: HKTC-EMA
nct id: NCT03235713
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to (1) evaluate the effectiveness of the recent renewal of tobacco health
      warnings (HWs) on noticing and anti-smoking responses, and (2) assess the effect of exposure
      to point-of-sale (POS) tobacco displays and smoking hotspots on nicotine-craving intensity
      and smoking-related behaviors. The study will use time-based system-triggered ecological
      momentary assessments to collect real-time data about exposures to smoking-related cues and
      behaviors. With a smartphone app installed in the mobile phones of the participants, they
      will each day complete at least 3 pairs of EMA prompted randomly for only 2 days (a working
      and a nonworking day). Outcomes include exposure and responses to tobacco HWs, exposure to
      POS tobacco displays, exposure to smoking hotspots and smoking and quitting outcomes.
1. Study Design The proposed study is a time-based system-triggered EMA which will collect
           real-time data about exposures to smoking-related cues and behaviors. With a smartphone
           app installed in the mobile phones of the participants, they will each day complete at
           least 3 pairs of EMA prompted randomly for only 2 days (a working and a non-working
           day). The prompting time will be sampled from the time when the participants are
           outdoor, so that more exposures to the tobacco HW, POS tobacco displays, and smoking
           hotspots can be captured. The EMA includes questions of the self-reported exposure to
           and/or responses to tobacco HWs, POS tobacco displays, smoking hotspots, craving
           intensity, and other smoking-related outcomes.

        2. Procedures The clinic counselors will briefly introduce all the clients in the clinics
           about the study during their visits. The clients who are interested will be referred to
           the on-site recruitment staff to screen for the eligibility. In the setting of retail
           shops and smoking hotspots, the recruitment staff will proactively approach the smokers.
           Eligible participants will be given more details of the study and invited to give a
           written consent for participation. Then, they will complete a baseline questionnaire
           administered by the recruitment staff. Afterwards, the staff will assist the
           participants to install the EMA app in their mobile phones, and ask the participants to
           select one working day and one non-working day, and then select at least 3 time windows
           for the EMA on each study day. These time windows can be their outdoor time when they
           are more likely to be exposed to the smoking-related locations, such as traveling to
           work, lunch time, or shopping. Then, the staff will set up the EMA schedule in the app
           for the participants, and train the participants to answer the questionnaire. A
           pocket-sized instruction card of using the app will be provided. The EMA will not
           interfere the smoking cessation intervention they receive in the clinic.

      To protect the privacy of the participants, several strategies will be adopted. First,
      participants will be reassured that all data are anonymous in the data collection and the
      analysis. All data will not be accessed by the clinic counselors. Second, no personal data
      (e.g. name and telephone numbers) will be collected in the app.

      The EMA validity largely relies on the participants' compliance, therefore an attractive
      incentive is needed. If they complete all the EMAs in the 2-day period, they will be given
      HK$200 dollar.

      After the data collection, the participants will be reminded to uninstall the app. They will
      be contacted to receive the incentive and complete the last questionnaire face-to-face.

      3 . EMA app The EMA app will be developed based on the app used in our aforementioned pilot
      randomized trial, which has a user-friendly interface and is easily operated. Users need to
      input at least 3 time windows (each for at least an hour) in each study day. In each time
      window, the app will firstly prompt the user at a random time to answer a set of
      questionnaire in the app, including questions on (1) exposure and responses to tobacco HW,
      (2) exposure to tobacco POS displays, (3) exposure to smoking hotspots, and (4) smoking and
      quitting outcomes. After 30 minutes of completing the first questionnaire, the app will
      prompt again the user to answer another set of questionnaire, which only assess smoking and
      quitting outcomes. The design of EMA pair within 30 minutes facilitates the analysis of
      causality, because we can capture some smoking or cravings preceded by the environmental
      exposures. Each questionnaire will take no more than 1 minute to complete. If an EMA prompt
      is not responded by the user, 2 additional prompts in every 5 minutes will be generated to
      remind the user to complete. The EMA will regard non-response as missing data if these
      additional prompts are not responded. All the above data will be sent to our server in each
      day.

      4. Statistical analysis Data will be analyzed with SPSS or Stata for Windows. The first
      research question can be addressed by comparing the frequency/proportion of the 4 HW-related
      outcomes pre- and post-implementation of the new warnings. To take into account the
      clustering between the outcomes within each participant, generalized estimating equation
      model will be used to assess the effect of new HWs on the noticing and responses to the HWs.
      To answer the second and third research questions, each EMA pair is the analysis unit, which
      is nested within each participant. The 3 outcome variables include the craving intensity
      (continuous variable), purchase of tobacco (binary) and smoking (binary). In the main
      analysis, linear mixed model (continuous) and mixed logistic regression model (binary) which
      allow for multiple observations in each subjects and account for clustering of data within
      subjects will be used to explore the association between each exposure variable and the
      outcome variables, adjusted for the variables collected at baseline. Significance level will
      be defined as p<0.05.

      5. Consent Participation in the study is voluntary. The recruitment staff will explain to the
      potential subjects who agree to join the study, before the written consent is requested. The
      subjects will be assured that they can withdraw from the study anytime without any prejudice,
      and all the information will be kept confidential and results will be reported in an
      aggregate format. Subjects are required to sign the written consent form.
observational model: Ecologic or Community
time perspective: Prospective
measure: Exposure and responses to tobacco HWs
time frame: 2 hours
description: The question set includes (1) whether he/she has noticed tobacco HWs in the past 2 hours (yes/no), (2) whether he/she has thought of the harms of smoking due to the HWs (yes/no), (3) whether he/she has thought of quitting due to the HWs (yes/no), and (4) whether he/she has forgone cigarettes due to PWs (yes/no). All items will be re-assessed in the later waves of EMA data collection.
measure: Exposure to POS tobacco displays
time frame: 2 hours
description: The question set includes (1) whether he/she has entered into any retail shops selling tobacco in the past hour (e.g. 7-11, OK) (yes/no), (2) if he/she has noticed tobacco POS displays in those retail shops in the past 2 hours (yes/no), and (3) in what extent he/she perceive the displays as attractive (5-point scale).
measure: Exposure to smoking hotspots
time frame: 2 hours
description: The question set includes (1) whether he/she has witnessed a group of smokers (at least 3 smokers) smoking at one specific outdoor area nearby a rubbish bin in the past 2 hours (yes/no), (2) if yes, whether he/she was within 3 meters of such "cluster" of smokers and (3) whether he/she has smoked at these places in the past hour (yes/no).
measure: Smoking and quitting outcomes
time frame: half an hour
description: The question set includes (1) the craving intensity in the past half hour (no craving, mild, fair, heavy, very heavy), (2) whether he/she has bought tobacco in the past half hour (yes/no), (3) whether he/she has smoked in past half hour (yes/no) and (4) whether the above responses have been due to the exposure to POS tobacco displays and/or smoking hotspots.
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: Derek Derek
role: Principal Investigator
affiliation: Tung Wah Group of Hospitals
facility: 
country: Hong Kong
responsible party type: Sponsor
sharing ipd: No