<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/NCT03760224</url>
  </required_header>
  <id_info>
    <org_study_id>Relapse Prevention 2018</org_study_id>
    <nct_id>NCT03760224</nct_id>
  </id_info>
  <brief_title>Effectiveness of WhatsApp Online Group Discussion for Smoking Relapse Prevention</brief_title>
  <official_title>Effectiveness of WhatsApp Online Group Discussion for Smoking Relapse Prevention: a Pragmatic Randomized Controlled Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to examine the effectiveness and cost-effectiveness of WhatsApp group&#xD;
      discussion for smoking relapse prevention. To assess the effect due to treatment modality&#xD;
      through the WhatsApp social group, the frequency and topics of the posts in each social group&#xD;
      will be analysed and in each participant. The primary hypothesis is whether quitters who&#xD;
      participate in the WhatsApp group discussion will have a higher prevalence of validated&#xD;
      tobacco abstinence at 12-month follow-up than those who do not. The second hypothesis is that&#xD;
      greater participation in the social groups, indicated by number of posts received, posted&#xD;
      and/or viewed, was associated with higher likelihood to quit at 12-month. The third&#xD;
      hypothesis is that the WhatsApp intervention for a recent quitter is a more cost-effective&#xD;
      option for tobacco abstinence and prolonged survival when compared to the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design:&#xD;
&#xD;
      This is a 2-arm open-labelled pragmatic randomized controlled trial, by comparing the&#xD;
      12-month tobacco abstinence between the recent quitters who will join WhatsApp group&#xD;
      discussion (Intervention group) and those who will not (Control group). A 1:1 randomised&#xD;
      allocation will be used. The intervention content for both trial arms in the proposed trial&#xD;
      will be the same and based on the US practice guidelines for smoking cessation, therefore the&#xD;
      intervention effects due to the treatment content will be the same in both groups. Only the&#xD;
      intervention platform (WhatsApp vs text messaging service) and the communication mode&#xD;
      (one-way vs interactive) will be different between the 2 groups. This trial will be a&#xD;
      pragmatic effectiveness trial to examine the effect of our intervention delivered under a&#xD;
      real-life setting. A less stringent eligibility criteria will be applied for the subjects,&#xD;
      unobtrusive measurement on adherence, and include all subjects in the final analysis&#xD;
      regardless of intervention compliance of each subject.&#xD;
&#xD;
      Subjects:&#xD;
&#xD;
      Patients who are receiving the smoking cessation service in the smoking cessation clinic of&#xD;
      the Queen Elizabeth Hospital, Tung Wah Groups of Hospital, Shau Kei Wan Jockey Club&#xD;
      Outpatient Clinic, Sai Ying Pun Jockey Club Outpatient Clinic and Pok Oi Chinese medicine&#xD;
      clinic. Smoking Cessation Service will be invited to go through the screening process. These&#xD;
      clinics are under Hospital Authority (n=3), or are non-governmental organizations that are&#xD;
      funded by the government (n=7). Patients with the following inclusion criteria will be&#xD;
      invited to participate in the RCT and will proceed to the recruitment procedure and&#xD;
      intervention phase (Phase 2).&#xD;
&#xD;
        1. Daily tobacco user before service intake&#xD;
&#xD;
        2. Aged 18 years or above&#xD;
&#xD;
        3. Have enrolled or re-enrolled in the smoking cessation treatment for no more than 8 weeks&#xD;
&#xD;
        4. Not using tobacco products (including traditional cigarettes and heat-not-burn tobacco&#xD;
           products) for 3 to 30 days&#xD;
&#xD;
        5. Able to communicate in Cantonese/Mandarin and read Chinese&#xD;
&#xD;
        6. Have a smart phone with local network connection The 4th criterion will be used because&#xD;
           our proposed RCT will target the quitters who have recently quit, and exclude those who&#xD;
           will have maintained a longer period of abstinence.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Do not use WhatsApp as communication tool and show no interest to use WhatsApp&#xD;
&#xD;
        -  Have unstable physical or psychological conditions as advised by doctors or counsellor&#xD;
           in charge&#xD;
&#xD;
        -  Have become pregnant in the past 2 months If the smoker meet all eligibility except the&#xD;
           abstinence (the 4th criterion), he/she will be introduced about our RCT and asked to&#xD;
           sign a consent form that allowing the HKU research staff to contact him again for&#xD;
           another screening in (Phase 1).&#xD;
&#xD;
      Procedures:&#xD;
&#xD;
      Recruitment:&#xD;
&#xD;
      During a usual smoking cessation counseling session, the clinic counsellor or onsite trial&#xD;
      recruitment staff (TRS) will briefly introduce the importance of relapse prevention and our&#xD;
      phone-based relapse prevention intervention to the patient. If the patient agree to join, the&#xD;
      TRS will then assess the eligibility section on the consent form. Patients who meet all the&#xD;
      eligibility criteria will (i) be introduced about the RCT that they will be randomized to&#xD;
      either the intervention or control group, and will participate in all follow-up assessments;&#xD;
      (ii) be asked to sign the consent form; (iii) fill in a baseline questionnaire; and (iv)&#xD;
      receive a leaflet, a self-help booklet and a souvenir. The consented participant will proceed&#xD;
      to the intervention phase (Phase 2) and will be informed group allocation (WhatsApp social&#xD;
      group (Intervention group) or text messaging service (control group)), where the option of&#xD;
      platform will be determined by a randomization procedure.&#xD;
&#xD;
      If participants meet all eligibility criteria in the first screening except the tobacco&#xD;
      abstinence for 3 to 30 days, the recruitment staff will invite them to set a quit day and&#xD;
      complete the above recruitment procedures, but not to be randomized at that time. TRS will&#xD;
      contact the participant 3 days after the quit date, and re-assess the eligibility of the RCT.&#xD;
      Then, the participant will complete a baseline questionnaire, and receive a leaflet, a&#xD;
      self-help booklet and a souvenir which are the same as those given to patient who meet all&#xD;
      criteria. These participants will proceed to Phase 1.&#xD;
&#xD;
      If the patient do not meet other eligibility criteria in the first screening, the TRS will&#xD;
      only provide a booklet (which are the same as those given to recruited patient) to the&#xD;
      patient. He/she will be regarded as recruitment failure.&#xD;
&#xD;
      Phase 1 (Telephone follow-up) The participants in Phase 1 will be contacted by TRS to confirm&#xD;
      the abstinence status. If the participant has not smoked for 3 days, the individual will be&#xD;
      asked again if he/she agrees to receive the phone-based relapse prevention intervention. If&#xD;
      agree, the TRS will briefly introduce again the RCT, and complete a brief questionnaire on&#xD;
      the telephone. Afterwards, the participant will proceed to the intervention phase (Phase 2).&#xD;
      If the participant disagrees, TRS will ask if he/she likes to participate in the study. If&#xD;
      the participant does not wish to participate in the study, then the individual consent form&#xD;
      will be destroyed and will not be contacted.&#xD;
&#xD;
      If the participant has not quit smoking, the TRS will ask the participant to set a quit date&#xD;
      again and ask his/her consent to be re-contacted for another telephone screening after the&#xD;
      quit date. Patients who do not want to be re-contacted will be regarded as recruitment&#xD;
      failure. Otherwise, the TRS will contact the participant again after the quit date.&#xD;
&#xD;
      Interventions (Phase 2) When the TRS (that has gone through training to be a WhatsApp group&#xD;
      moderator) collects about 7 to 14 participants (who have met all eligibility criteria) every&#xD;
      one or two weeks from all clinics, he/she will set up the WhatsApp group with them. Each&#xD;
      WhatsApp group (about 50 groups in total) will allow real-time group discussion for 8 weeks.&#xD;
      The participants will receive each week at least 3 text messages or videos from a moderator,&#xD;
      which will be based on the six approaches delineated in &quot;Treatments for the Recent Quitter&quot;&#xD;
      of the US Clinical Practice Guidelines on Treating Tobacco Use and Dependence. Based on the&#xD;
      Positive Psychology theories, a framework of four principles to enhance the online group&#xD;
      moderation: (1) Using active listening skills to understand the thoughts and feelings behind&#xD;
      individual's sharing; (2) Showing sincere, immediate, specific, and concrete appreciation and&#xD;
      gratitude towards their sharing; (3) Mindful awareness of the group dynamics and giving&#xD;
      strategic reactions; (4) Enhancement of self-efficacy, sense of control and satisfaction&#xD;
      among the individual. All messages will address the five common problems leading to smoking&#xD;
      relapse delineated in &quot;Treatments for the Recent Quitter&quot; of the US Clinical Practice&#xD;
      Guidelines on Treating Tobacco Use and Dependence (26), including (1) lack of support for&#xD;
      cessation; (2) negative mood or depression; (3) strong prolonged withdrawal symptoms; (4)&#xD;
      weight gain; and (5) smoking lapses. If any participant shares their lapse or relapse&#xD;
      experience in the group, the moderator will engage other individual to provide appreciation&#xD;
      and support, or, if that individual agreed, actively refer him/her to existing cessation&#xD;
      services.&#xD;
&#xD;
      To ensure quality assurance and intervention fidelity, all moderators will be provided&#xD;
      training of smoking cessation knowledge, and moderating skills to motivate individual to&#xD;
      share in WhatsApp. Moderators will also be trained on Positive Psychology by psychologist and&#xD;
      counsellors from United Christian Hospital, United Centre of Emotional Health and Positive&#xD;
      Living. This would allow moderators to learn a more positive approach to the language use&#xD;
      within the group discussion and ways to express gratitude. The control group will only&#xD;
      receive 3 mobile phone text messages each week in the 8 weeks after recruitment. These&#xD;
      messages will be similar to those received by the intervention group. Our intervention will&#xD;
      not interrupt the services that all individual will be receiving in the cessation clinics.&#xD;
&#xD;
      Several measures will be used to protect the privacy of personal data and internet safety of&#xD;
      joining the WhatsApp groups. First, male and female individual in the WhatsApp group will be&#xD;
      separated into different WhatsApp groups to avoid the possibility of misconduct or&#xD;
      harassment. Second, participants will be reassured that all the WhatsApp posts can only be&#xD;
      read by the individual and the moderator in the group as stated in the consent form. The TRS&#xD;
      will only analyse all the data and WhatsApp posts anonymously. Third, moderator will&#xD;
      encourage all the participants in the WhatsApp groups to share and post messages in the&#xD;
      group, and avoid 1-to-1 individual communication via any channels within the study period.&#xD;
      The moderator will also encourage the individual to report if anyone violate this regulation,&#xD;
      and, if so, may give warnings to that individual. If the participant severely violate this&#xD;
      regulation, this may result in termination of their participation. The moderator will also&#xD;
      monitor the group conversation and report any events of misusing the contact information in&#xD;
      the WhatsApp to the lead PI. This can reduce the chance of any misconduct, harassment,&#xD;
      sharing and spread of harmful programs or virus, and unauthorized marketing using the contact&#xD;
      information. Fourth, to avoid any internet virus or harmful links, the moderators will remind&#xD;
      the group members not to open any suspicious links and files via WhatsApp. Lastly, individual&#xD;
      can withdraw from the intervention study anytime over the study period. In the pilot RCT,&#xD;
      about 83.4% of the eligible individual agreed to participate in the WhatsApp social groups&#xD;
      after informed the above ethical issues.&#xD;
&#xD;
      After the recruitment, TRS will immediately send the contact details of the participant to&#xD;
      our research staff for the randomization procedures.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      TRS will send the Information of all the participant to the research staff, who are&#xD;
      responsible to randomly allocate the group assignment. The principal investigator will&#xD;
      generate a list of random numbers (for each recruitment site) and a list of group allocation,&#xD;
      using the rand function of Excel. TRS will assign group allocation to each participant based&#xD;
      on the list, followed by the intervention delivery.&#xD;
&#xD;
      Allocation concealment:&#xD;
&#xD;
      All TRS and participants will be concealed to the group allocation at recruitment. This&#xD;
      randomization procedure will be done by the research staff in the research office.&#xD;
&#xD;
      Blinding:&#xD;
&#xD;
      The participant and group moderators cannot and will not be blinded to the intervention.&#xD;
      Assessors of the follow-up outcomes and the research analysts will not be involved in the&#xD;
      recruitment and intervention delivery, and will be blinded to the group allocation (single&#xD;
      blindness).&#xD;
&#xD;
      Follow-up:&#xD;
&#xD;
      All individuals will be followed up via telephone by an allocation-blinded interviewer at 3-,&#xD;
      6- and 12-month after the random group allocation. Only the individual who report abstinence&#xD;
      in the past 7 days during the 6- and 12- month follow-up will be invited to provide samples&#xD;
      of exhaled breath and/or saliva for biochemical validation at their residence, workplace, or&#xD;
      nearby, as preferred by the quitters. The Bedfont Smokerlyzer and iScreen OFD Cotinine Saliva&#xD;
      Test Kit will be used for validations. The validation takes very short time (3 minutes ) and&#xD;
      is easy.&#xD;
&#xD;
      Sample size determination:&#xD;
&#xD;
      Our pilot RCT showed that the OR of the CO validated quit rates between the intervention and&#xD;
      control group was 2.04 (95%CI 0.74-5.65) (Intervention: 26.0%, Control: 15.0%). Because our&#xD;
      proposed RCT will recruit quitters who have recently quit, PI have conservatively estimated&#xD;
      that the OR will be 1.70 (23.0% vs 15.0%). To detect a significant difference of quit rate&#xD;
      with 2-tailed z-test by GPower 3.1 between the two groups with a power of 90% (to reduce type&#xD;
      II error) and 5% significant level (type I error), 1,008 participantswill be needed in total&#xD;
      (504 individual per group).&#xD;
&#xD;
      Data analyses&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Using intention-to-treat analysis, participants who are lost to follow-up or drop out will be&#xD;
      treated as smokers with no changes in daily cigarette consumption. The odds ratio, risk&#xD;
      difference, and 95% confidence interval will be used to compare the primary and secondary&#xD;
      outcomes between the two trial groups. Number needed to treat (NNT), which shows the number&#xD;
      of treated participants needed to have one additional quitter at 12-month, will be computed&#xD;
      by taking the reciprocal of the risk difference between the two trial groups. Assuming the&#xD;
      missing outcomes are dependent on observed data (missing at random), an analysis using the&#xD;
      multiple imputation (MI) procedure to impute the missing data will be conducted as&#xD;
      sensitivity analysis. On the assumption that there will be no heterogeneity of intervention&#xD;
      effect across clinics, the primary analysis will be conducted using logistic regression with&#xD;
      and without adjustment for baseline characteristics. The assumption of homogeneity will first&#xD;
      be checked by testing the clinic by intervention interaction with clinic as a fixed effect in&#xD;
      the logistic model. If there is evidence of heterogeneity (i.e. p-value &lt; 0.1), an analysis&#xD;
      by generalized linear mixed (GLM) model with clinic as a random effect will be used to&#xD;
      summarize the intervention effect on the primary outcome. Number of posts received and posted&#xD;
      by each participant will be documented, and then included in the final GLM model to assess&#xD;
      their association with the cessation outcome. All data analysis will be done using IBM SPSS&#xD;
      version 25.0.&#xD;
&#xD;
      Text mining of the WhatsApp groups:&#xD;
&#xD;
      All discussion content will be archived and anonymized to remove identifying personal&#xD;
      information. Due to a huge number of messages from the 50 WhatsApp groups, an automatic,&#xD;
      computational text mining and visualization of the dataset will be used for the content&#xD;
      analysis. First, utilizing a lexicon of keywords derived from our qualitative analysis of the&#xD;
      pilot RCT, a heatmap visualization will be developed to illustrate the prevalence of the&#xD;
      discussion topics. Second, topic modelling will be applied to investigate emerging themes in&#xD;
      our WhatsApp dataset, using the Mallet implementation of the Latent Dirichlet Allocation&#xD;
      topic modelling algorithm. Topic modelling algorithms take as input a text dataset (in this&#xD;
      case, the WhatsApp dataset), and output a set of topics (and their associated keywords) in&#xD;
      addition to estimates of the proportion of each topic.&#xD;
&#xD;
      Qualitative interview&#xD;
&#xD;
      To collect opinions towards the WhatsApp group intervention, purposive sampling will be used&#xD;
      to select 20 individuals from the intervention group including both sexes, all age groups and&#xD;
      all smoking status at 12-month, to participate in a qualitative face-to-face or telephone&#xD;
      interview after the intervention. An interview guide with open-ended and iterative questions&#xD;
      was used to probe for more experiences from the interviewees. Each interview will be&#xD;
      conducted by the PI and a trained research assistant, and will last about 30 to 60 minutes.&#xD;
&#xD;
      The interview content was transcribed verbatim in Chinese for further analysis. The&#xD;
      qualitative interview transcripts will be analysed using framework analysis to construct a&#xD;
      coherent and logical structure from the classification of many opinions and perceptions of&#xD;
      social groups. Lead PI and two trained research assistants first used the open-coding method&#xD;
      to identify relevant content in the transcripts; next, the lead PI will classified all&#xD;
      labelled content into several independent themes showing distinct features of the social&#xD;
      groups. The results were then discussed and consolidated in the panel meetings with the Co-I.&#xD;
&#xD;
      Cost-effectiveness analysis :&#xD;
&#xD;
      Cost-effectiveness analysis will be undertaken to indicate whether the intervention will be&#xD;
      more cost-effective or even cost-saving option for a quitter over a time horizon of one year&#xD;
      (within trial period) and lifetime. Within and lifetime cost-effectiveness analyses will be&#xD;
      populated based on the healthcare provider perspective.&#xD;
&#xD;
      Model parameters input will be identified through within trial data and a review of local and&#xD;
      overseas literature, where necessary. Within trial cost-effectiveness of WhatsApp&#xD;
      intervention versus control group will be evaluated using total costs, the number of tobacco&#xD;
      abstinence and total QALYs over the study period. EQ-5D-5L utility data at baseline and&#xD;
      follow-ups from trial will estimate QALYs in two groups using area under the curve technique.&#xD;
      Lifetime cost-effectiveness will be performed via Markov modelling that will simulate the&#xD;
      annual health status progression of subjects in either intervention or control group. Both&#xD;
      the successful and unsuccessful quitters after the trial will be subject to the annual&#xD;
      transition probability from a status of no diseases to lung cancer, cardiovascular diseases,&#xD;
      and other diseases, and then mortality. Former smokers may be relapsed after abstinence.&#xD;
      Discounting will only be applied to total costs and QALY calculation under the lifetime&#xD;
      horizon. Sensitivity analyses will be conducted where each parameter will be set at plausible&#xD;
      lower and upper bounds based on 95% confidence interval of estimates in above data analysis.&#xD;
&#xD;
      The incremental cost-effectiveness ratio (ICER) in terms of cost per an additional tobacco&#xD;
      abstinence gained, life-years gained, or QALYs gained for the intervention group in&#xD;
      comparison to the control group will be reported. The WhatsApp intervention will be&#xD;
      considered as cost-effective if its ICER will be less than 3 times per capita gross domestic&#xD;
      product in Hong Kong recommended by WHO or the potential ICER threshold in Hong Kong. The&#xD;
      cost-effectiveness model will be built using Microsoft Excel or Treeage Pro software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2018</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Passed the Biochemical Validated Abstinence at 12-month Follow-up</measure>
    <time_frame>12 month</time_frame>
    <description>Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Passed the Biochemical Validated Abstinence at 6-month Follow-up</measure>
    <time_frame>6 month</time_frame>
    <description>Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-reported 7-day Abstinence at 3-month Follow-up</measure>
    <time_frame>3 month</time_frame>
    <description>Self-reported abstinence in the past 7 days at 3-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Self-reported 7-day Abstinence at 6-month Follow-up</measure>
    <time_frame>6 month</time_frame>
    <description>Self-reported abstinence in the past 7 days at 6-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Self-reported 7-day Abstinence at 12-month Follow-up</measure>
    <time_frame>12 month</time_frame>
    <description>Self-reported abstinence in the past 7 days at 12-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Smoking Relapse at 3-month Follow-up</measure>
    <time_frame>3 month</time_frame>
    <description>Consuming 5 cigarettes or more in 3 consecutive days in the past 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Smoking Relapse at 6-month Follow-up</measure>
    <time_frame>6 month</time_frame>
    <description>Consuming 5 cigarettes or more in 3 consecutive days in the past 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Smoking Relapse at 12-month Follow-up</measure>
    <time_frame>12 month</time_frame>
    <description>Consuming 5 cigarettes or more in 3 consecutive days in the past 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Self-reported Continuous Abstinence</measure>
    <time_frame>3 month</time_frame>
    <description>Self-reported continuous abstinence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-reported Continuous Abstinence</measure>
    <time_frame>6 month</time_frame>
    <description>Self-reported continuous abstinence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Self-reported Continuous Abstinence</measure>
    <time_frame>12 month</time_frame>
    <description>Self-reported continuous abstinence</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Frequency of Smoking Urge</measure>
    <time_frame>3 month</time_frame>
    <description>Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).</description>
  </other_outcome>
  <other_outcome>
    <measure>Intensity of Smoking Urge</measure>
    <time_frame>3 month</time_frame>
    <description>Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of Smoking Urge</measure>
    <time_frame>6 month</time_frame>
    <description>Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).</description>
  </other_outcome>
  <other_outcome>
    <measure>Intensity of Smoking Urge</measure>
    <time_frame>6 month</time_frame>
    <description>Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of Smoking Urge</measure>
    <time_frame>12 month</time_frame>
    <description>Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).</description>
  </other_outcome>
  <other_outcome>
    <measure>Intensity of Smoking Urge</measure>
    <time_frame>12 month</time_frame>
    <description>Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).</description>
  </other_outcome>
  <other_outcome>
    <measure>EuroQoL 5-Dimension 5-Level (EQ-5D-5L)</measure>
    <time_frame>3 month</time_frame>
    <description>EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).</description>
  </other_outcome>
  <other_outcome>
    <measure>EuroQoL 5-Dimension 5-Level (EQ-5D-5L)</measure>
    <time_frame>6 month</time_frame>
    <description>EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).</description>
  </other_outcome>
  <other_outcome>
    <measure>EuroQoL 5-Dimension 5-Level (EQ-5D-5L)</measure>
    <time_frame>12 month</time_frame>
    <description>EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Quality of Life Inventory</measure>
    <time_frame>6 month</time_frame>
    <description>Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Quality of Life Inventory</measure>
    <time_frame>12 month</time_frame>
    <description>Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nicotine Withdrawals</measure>
    <time_frame>3 month</time_frame>
    <description>Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nicotine Withdrawals</measure>
    <time_frame>6 month</time_frame>
    <description>Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nicotine Withdrawals</measure>
    <time_frame>12 month</time_frame>
    <description>Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">928</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WhatsApp group</intervention_name>
    <description>WhatsApp group will allow real-time group discussion for 8 weeks</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS group</intervention_name>
    <description>SMS group for 8 weeks</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Daily tobacco user before service intake&#xD;
&#xD;
          -  Aged 18 years or above&#xD;
&#xD;
          -  Have enrolled or re-enrolled in the smoking cessation treatment for no more than 8&#xD;
             weeks&#xD;
&#xD;
          -  Not using tobacco products (including traditional cigarettes and heat-not-burn tobacco&#xD;
             products) for 3 to 30 days&#xD;
&#xD;
          -  Able to communicate in Cantonese/Mandarin and read Chinese&#xD;
&#xD;
          -  Have a smart phone with local network connection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not use WhatsApp as communication tool and show no interest to use WhatsApp&#xD;
&#xD;
          -  Have unstable physical or psychological conditions as advised by doctors or counsellor&#xD;
             in charge&#xD;
&#xD;
          -  Have become pregnant in the past 2 months&#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>
  <location>
    <facility>
      <name>Hong Kong University</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
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  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>October 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>January 14, 2022</results_first_submitted>
  <results_first_submitted_qc>March 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 18, 2022</results_first_posted>
  <last_update_submitted>March 19, 2022</last_update_submitted>
  <last_update_submitted_qc>March 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Derek Yee-Tak Cheung</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Intervention</keyword>
  <keyword>WhatsApp</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Relapse Prevention</keyword>
  <keyword>Group Disscussion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Research data and documentation will be available upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>3 years</ipd_time_frame>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03760224/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Based on our pilot study, we calculated our sample size to be 1008 participants. As we predicted that there would be participants who fail to be contacted or fail to quit for 3 days, we recruited more than the target number of participants before the start of the intervention. Yet, due to the COVID-19, we recruited 928 participants and enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="469"/>
                <participants group_id="P2" count="459"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="469"/>
                <participants group_id="P2" count="459"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="469"/>
            <count group_id="B2" value="459"/>
            <count group_id="B3" value="928"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="443"/>
                    <measurement group_id="B2" value="434"/>
                    <measurement group_id="B3" value="877"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="43.00" spread="11.70"/>
                    <measurement group_id="B2" value="42.97" spread="11.72"/>
                    <measurement group_id="B3" value="42.99" spread="11.60"/>
                  </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="85"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="384"/>
                    <measurement group_id="B2" value="356"/>
                    <measurement group_id="B3" value="740"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="469"/>
                    <measurement group_id="B2" value="459"/>
                    <measurement group_id="B3" value="928"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>Hong Kong</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="469"/>
                    <measurement group_id="B2" value="459"/>
                    <measurement group_id="B3" value="928"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fagerstrom Test For Nicotine Dependence</title>
          <description>The total score ranged from 0 to 10. A higher score indicates the participants' more intense physical dependence on nicotine.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.1" spread="2.5"/>
                    <measurement group_id="B2" value="5.1" spread="2.6"/>
                    <measurement group_id="B3" value="5.1" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Minnesota Nicotine Withdrawal Scale</title>
          <description>The total score ranged from 0 to 36. A higher score indicates participants had more withdrawal symptoms.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.1" spread="6.8"/>
                    <measurement group_id="B2" value="18.0" spread="7.0"/>
                    <measurement group_id="B3" value="18.1" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Importance of quitting</title>
          <description>The importance of quitting will be evaluated on a scale of 0 to 10 (0, least important; 10, most important). For the scale of measuring quitting importance, higher scores mean a better outcome.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.4" spread="1.8"/>
                    <measurement group_id="B2" value="8.4" spread="1.6"/>
                    <measurement group_id="B3" value="8.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Difficulty of quitting</title>
          <description>The difficulty of quitting will be evaluated on a scale of 0 to 10 (0, least difficult; 10, most difficult). For the scale of measuring quitting difficulty, higher scores mean a worse outcome.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.4" spread="2.2"/>
                    <measurement group_id="B2" value="7.4" spread="2.1"/>
                    <measurement group_id="B3" value="7.4" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Confidence of quitting</title>
          <description>Confidence in quitting will be evaluated on a scale of 0 to 10 (0, least confident; 10, most confident). For the scale of measuring quitting confidence, higher scores mean a better outcome.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.4" spread="2.2"/>
                    <measurement group_id="B2" value="6.6" spread="2.2"/>
                    <measurement group_id="B3" value="6.5" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Passed the Biochemical Validated Abstinence at 12-month Follow-up</title>
        <description>Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit</description>
        <time_frame>12 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Passed the Biochemical Validated Abstinence at 12-month Follow-up</title>
          <description>Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Passed the Biochemical Validated Abstinence at 6-month Follow-up</title>
        <description>Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Passed the Biochemical Validated Abstinence at 6-month Follow-up</title>
          <description>Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-reported 7-day Abstinence at 3-month Follow-up</title>
        <description>Self-reported abstinence in the past 7 days at 3-month follow-up</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-reported 7-day Abstinence at 3-month Follow-up</title>
          <description>Self-reported abstinence in the past 7 days at 3-month follow-up</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="256"/>
                    <measurement group_id="O2" value="257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Self-reported 7-day Abstinence at 6-month Follow-up</title>
        <description>Self-reported abstinence in the past 7 days at 6-month follow-up</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Self-reported 7-day Abstinence at 6-month Follow-up</title>
          <description>Self-reported abstinence in the past 7 days at 6-month follow-up</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="229"/>
                    <measurement group_id="O2" value="232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Self-reported 7-day Abstinence at 12-month Follow-up</title>
        <description>Self-reported abstinence in the past 7 days at 12-month follow-up</description>
        <time_frame>12 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Self-reported 7-day Abstinence at 12-month Follow-up</title>
          <description>Self-reported abstinence in the past 7 days at 12-month follow-up</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200"/>
                    <measurement group_id="O2" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Smoking Relapse at 3-month Follow-up</title>
        <description>Consuming 5 cigarettes or more in 3 consecutive days in the past 3 months</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Smoking Relapse at 3-month Follow-up</title>
          <description>Consuming 5 cigarettes or more in 3 consecutive days in the past 3 months</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="213"/>
                    <measurement group_id="O2" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Smoking Relapse at 6-month Follow-up</title>
        <description>Consuming 5 cigarettes or more in 3 consecutive days in the past 6 months</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Smoking Relapse at 6-month Follow-up</title>
          <description>Consuming 5 cigarettes or more in 3 consecutive days in the past 6 months</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240"/>
                    <measurement group_id="O2" value="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Smoking Relapse at 12-month Follow-up</title>
        <description>Consuming 5 cigarettes or more in 3 consecutive days in the past 12 months</description>
        <time_frame>12 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Smoking Relapse at 12-month Follow-up</title>
          <description>Consuming 5 cigarettes or more in 3 consecutive days in the past 12 months</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="269"/>
                    <measurement group_id="O2" value="243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Self-reported Continuous Abstinence</title>
        <description>Self-reported continuous abstinence</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Self-reported Continuous Abstinence</title>
          <description>Self-reported continuous abstinence</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="256"/>
                    <measurement group_id="O2" value="257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-reported Continuous Abstinence</title>
        <description>Self-reported continuous abstinence</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-reported Continuous Abstinence</title>
          <description>Self-reported continuous abstinence</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Self-reported Continuous Abstinence</title>
        <description>Self-reported continuous abstinence</description>
        <time_frame>12 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Self-reported Continuous Abstinence</title>
          <description>Self-reported continuous abstinence</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Frequency of Smoking Urge</title>
        <description>Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Smoking Urge</title>
          <description>Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.09" spread="1.21"/>
                    <measurement group_id="O2" value="2.13" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Intensity of Smoking Urge</title>
        <description>Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Smoking Urge</title>
          <description>Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.70" spread="0.95"/>
                    <measurement group_id="O2" value="1.79" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Frequency of Smoking Urge</title>
        <description>Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Smoking Urge</title>
          <description>Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.72" spread="1.12"/>
                    <measurement group_id="O2" value="1.73" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Intensity of Smoking Urge</title>
        <description>Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Smoking Urge</title>
          <description>Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.46" spread="0.83"/>
                    <measurement group_id="O2" value="1.46" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Frequency of Smoking Urge</title>
        <description>Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).</description>
        <time_frame>12 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Smoking Urge</title>
          <description>Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.04" spread="1.37"/>
                    <measurement group_id="O2" value="2.07" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Intensity of Smoking Urge</title>
        <description>Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).</description>
        <time_frame>12 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Intensity of Smoking Urge</title>
          <description>Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="0.82"/>
                    <measurement group_id="O2" value="1.39" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>EuroQoL 5-Dimension 5-Level (EQ-5D-5L)</title>
        <description>EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL 5-Dimension 5-Level (EQ-5D-5L)</title>
          <description>EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="0.13"/>
                    <measurement group_id="O2" value="0.97" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>EuroQoL 5-Dimension 5-Level (EQ-5D-5L)</title>
        <description>EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL 5-Dimension 5-Level (EQ-5D-5L)</title>
          <description>EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="0.11"/>
                    <measurement group_id="O2" value="0.95" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>EuroQoL 5-Dimension 5-Level (EQ-5D-5L)</title>
        <description>EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).</description>
        <time_frame>12 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL 5-Dimension 5-Level (EQ-5D-5L)</title>
          <description>EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="0.09"/>
                    <measurement group_id="O2" value="0.97" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Quality of Life Inventory</title>
        <description>Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family.</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Inventory</title>
          <description>Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="1.25"/>
                    <measurement group_id="O2" value="2.31" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Quality of Life Inventory</title>
        <description>Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family.</description>
        <time_frame>12 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Inventory</title>
          <description>Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" spread="1.30"/>
                    <measurement group_id="O2" value="2.46" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Nicotine Withdrawals</title>
        <description>Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.</description>
        <time_frame>3 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Nicotine Withdrawals</title>
          <description>Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.85" spread="3.88"/>
                    <measurement group_id="O2" value="12.37" spread="4.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Nicotine Withdrawals</title>
        <description>Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.</description>
        <time_frame>6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Nicotine Withdrawals</title>
          <description>Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.30" spread="3.27"/>
                    <measurement group_id="O2" value="11.71" spread="4.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Nicotine Withdrawals</title>
        <description>Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.</description>
        <time_frame>12 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Nicotine Withdrawals</title>
          <description>Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="469"/>
                <count group_id="O2" value="459"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.90" spread="3.72"/>
                    <measurement group_id="O2" value="11.46" spread="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).&#xD;
WhatsApp group: WhatsApp group will allow real-time group discussion for 8 weeks</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.&#xD;
SMS group: SMS group for 8 weeks</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="469"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="459"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="469"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="459"/>
              </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="469"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="459"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Derek Cheung</name_or_title>
      <organization>University of Hong Kong</organization>
      <phone>39176652</phone>
      <email>derekcheung@hku.hk</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/NCT03760224
org study id: Relapse Prevention 2018
nct id: NCT03760224
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to examine the effectiveness and cost-effectiveness of WhatsApp group
      discussion for smoking relapse prevention. To assess the effect due to treatment modality
      through the WhatsApp social group, the frequency and topics of the posts in each social group
      will be analysed and in each participant. The primary hypothesis is whether quitters who
      participate in the WhatsApp group discussion will have a higher prevalence of validated
      tobacco abstinence at 12-month follow-up than those who do not. The second hypothesis is that
      greater participation in the social groups, indicated by number of posts received, posted
      and/or viewed, was associated with higher likelihood to quit at 12-month. The third
      hypothesis is that the WhatsApp intervention for a recent quitter is a more cost-effective
      option for tobacco abstinence and prolonged survival when compared to the control group.
Study design:

      This is a 2-arm open-labelled pragmatic randomized controlled trial, by comparing the
      12-month tobacco abstinence between the recent quitters who will join WhatsApp group
      discussion (Intervention group) and those who will not (Control group). A 1:1 randomised
      allocation will be used. The intervention content for both trial arms in the proposed trial
      will be the same and based on the US practice guidelines for smoking cessation, therefore the
      intervention effects due to the treatment content will be the same in both groups. Only the
      intervention platform (WhatsApp vs text messaging service) and the communication mode
      (one-way vs interactive) will be different between the 2 groups. This trial will be a
      pragmatic effectiveness trial to examine the effect of our intervention delivered under a
      real-life setting. A less stringent eligibility criteria will be applied for the subjects,
      unobtrusive measurement on adherence, and include all subjects in the final analysis
      regardless of intervention compliance of each subject.

      Subjects:

      Patients who are receiving the smoking cessation service in the smoking cessation clinic of
      the Queen Elizabeth Hospital, Tung Wah Groups of Hospital, Shau Kei Wan Jockey Club
      Outpatient Clinic, Sai Ying Pun Jockey Club Outpatient Clinic and Pok Oi Chinese medicine
      clinic. Smoking Cessation Service will be invited to go through the screening process. These
      clinics are under Hospital Authority (n=3), or are non-governmental organizations that are
      funded by the government (n=7). Patients with the following inclusion criteria will be
      invited to participate in the RCT and will proceed to the recruitment procedure and
      intervention phase (Phase 2).

        1. Daily tobacco user before service intake

        2. Aged 18 years or above

        3. Have enrolled or re-enrolled in the smoking cessation treatment for no more than 8 weeks

        4. Not using tobacco products (including traditional cigarettes and heat-not-burn tobacco
           products) for 3 to 30 days

        5. Able to communicate in Cantonese/Mandarin and read Chinese

        6. Have a smart phone with local network connection The 4th criterion will be used because
           our proposed RCT will target the quitters who have recently quit, and exclude those who
           will have maintained a longer period of abstinence.

      Exclusion criteria:

        -  Do not use WhatsApp as communication tool and show no interest to use WhatsApp

        -  Have unstable physical or psychological conditions as advised by doctors or counsellor
           in charge

        -  Have become pregnant in the past 2 months If the smoker meet all eligibility except the
           abstinence (the 4th criterion), he/she will be introduced about our RCT and asked to
           sign a consent form that allowing the HKU research staff to contact him again for
           another screening in (Phase 1).

      Procedures:

      Recruitment:

      During a usual smoking cessation counseling session, the clinic counsellor or onsite trial
      recruitment staff (TRS) will briefly introduce the importance of relapse prevention and our
      phone-based relapse prevention intervention to the patient. If the patient agree to join, the
      TRS will then assess the eligibility section on the consent form. Patients who meet all the
      eligibility criteria will (i) be introduced about the RCT that they will be randomized to
      either the intervention or control group, and will participate in all follow-up assessments;
      (ii) be asked to sign the consent form; (iii) fill in a baseline questionnaire; and (iv)
      receive a leaflet, a self-help booklet and a souvenir. The consented participant will proceed
      to the intervention phase (Phase 2) and will be informed group allocation (WhatsApp social
      group (Intervention group) or text messaging service (control group)), where the option of
      platform will be determined by a randomization procedure.

      If participants meet all eligibility criteria in the first screening except the tobacco
      abstinence for 3 to 30 days, the recruitment staff will invite them to set a quit day and
      complete the above recruitment procedures, but not to be randomized at that time. TRS will
      contact the participant 3 days after the quit date, and re-assess the eligibility of the RCT.
      Then, the participant will complete a baseline questionnaire, and receive a leaflet, a
      self-help booklet and a souvenir which are the same as those given to patient who meet all
      criteria. These participants will proceed to Phase 1.

      If the patient do not meet other eligibility criteria in the first screening, the TRS will
      only provide a booklet (which are the same as those given to recruited patient) to the
      patient. He/she will be regarded as recruitment failure.

      Phase 1 (Telephone follow-up) The participants in Phase 1 will be contacted by TRS to confirm
      the abstinence status. If the participant has not smoked for 3 days, the individual will be
      asked again if he/she agrees to receive the phone-based relapse prevention intervention. If
      agree, the TRS will briefly introduce again the RCT, and complete a brief questionnaire on
      the telephone. Afterwards, the participant will proceed to the intervention phase (Phase 2).
      If the participant disagrees, TRS will ask if he/she likes to participate in the study. If
      the participant does not wish to participate in the study, then the individual consent form
      will be destroyed and will not be contacted.

      If the participant has not quit smoking, the TRS will ask the participant to set a quit date
      again and ask his/her consent to be re-contacted for another telephone screening after the
      quit date. Patients who do not want to be re-contacted will be regarded as recruitment
      failure. Otherwise, the TRS will contact the participant again after the quit date.

      Interventions (Phase 2) When the TRS (that has gone through training to be a WhatsApp group
      moderator) collects about 7 to 14 participants (who have met all eligibility criteria) every
      one or two weeks from all clinics, he/she will set up the WhatsApp group with them. Each
      WhatsApp group (about 50 groups in total) will allow real-time group discussion for 8 weeks.
      The participants will receive each week at least 3 text messages or videos from a moderator,
      which will be based on the six approaches delineated in "Treatments for the Recent Quitter"
      of the US Clinical Practice Guidelines on Treating Tobacco Use and Dependence. Based on the
      Positive Psychology theories, a framework of four principles to enhance the online group
      moderation: (1) Using active listening skills to understand the thoughts and feelings behind
      individual's sharing; (2) Showing sincere, immediate, specific, and concrete appreciation and
      gratitude towards their sharing; (3) Mindful awareness of the group dynamics and giving
      strategic reactions; (4) Enhancement of self-efficacy, sense of control and satisfaction
      among the individual. All messages will address the five common problems leading to smoking
      relapse delineated in "Treatments for the Recent Quitter" of the US Clinical Practice
      Guidelines on Treating Tobacco Use and Dependence (26), including (1) lack of support for
      cessation; (2) negative mood or depression; (3) strong prolonged withdrawal symptoms; (4)
      weight gain; and (5) smoking lapses. If any participant shares their lapse or relapse
      experience in the group, the moderator will engage other individual to provide appreciation
      and support, or, if that individual agreed, actively refer him/her to existing cessation
      services.

      To ensure quality assurance and intervention fidelity, all moderators will be provided
      training of smoking cessation knowledge, and moderating skills to motivate individual to
      share in WhatsApp. Moderators will also be trained on Positive Psychology by psychologist and
      counsellors from United Christian Hospital, United Centre of Emotional Health and Positive
      Living. This would allow moderators to learn a more positive approach to the language use
      within the group discussion and ways to express gratitude. The control group will only
      receive 3 mobile phone text messages each week in the 8 weeks after recruitment. These
      messages will be similar to those received by the intervention group. Our intervention will
      not interrupt the services that all individual will be receiving in the cessation clinics.

      Several measures will be used to protect the privacy of personal data and internet safety of
      joining the WhatsApp groups. First, male and female individual in the WhatsApp group will be
      separated into different WhatsApp groups to avoid the possibility of misconduct or
      harassment. Second, participants will be reassured that all the WhatsApp posts can only be
      read by the individual and the moderator in the group as stated in the consent form. The TRS
      will only analyse all the data and WhatsApp posts anonymously. Third, moderator will
      encourage all the participants in the WhatsApp groups to share and post messages in the
      group, and avoid 1-to-1 individual communication via any channels within the study period.
      The moderator will also encourage the individual to report if anyone violate this regulation,
      and, if so, may give warnings to that individual. If the participant severely violate this
      regulation, this may result in termination of their participation. The moderator will also
      monitor the group conversation and report any events of misusing the contact information in
      the WhatsApp to the lead PI. This can reduce the chance of any misconduct, harassment,
      sharing and spread of harmful programs or virus, and unauthorized marketing using the contact
      information. Fourth, to avoid any internet virus or harmful links, the moderators will remind
      the group members not to open any suspicious links and files via WhatsApp. Lastly, individual
      can withdraw from the intervention study anytime over the study period. In the pilot RCT,
      about 83.4% of the eligible individual agreed to participate in the WhatsApp social groups
      after informed the above ethical issues.

      After the recruitment, TRS will immediately send the contact details of the participant to
      our research staff for the randomization procedures.

      Randomization:

      TRS will send the Information of all the participant to the research staff, who are
      responsible to randomly allocate the group assignment. The principal investigator will
      generate a list of random numbers (for each recruitment site) and a list of group allocation,
      using the rand function of Excel. TRS will assign group allocation to each participant based
      on the list, followed by the intervention delivery.

      Allocation concealment:

      All TRS and participants will be concealed to the group allocation at recruitment. This
      randomization procedure will be done by the research staff in the research office.

      Blinding:

      The participant and group moderators cannot and will not be blinded to the intervention.
      Assessors of the follow-up outcomes and the research analysts will not be involved in the
      recruitment and intervention delivery, and will be blinded to the group allocation (single
      blindness).

      Follow-up:

      All individuals will be followed up via telephone by an allocation-blinded interviewer at 3-,
      6- and 12-month after the random group allocation. Only the individual who report abstinence
      in the past 7 days during the 6- and 12- month follow-up will be invited to provide samples
      of exhaled breath and/or saliva for biochemical validation at their residence, workplace, or
      nearby, as preferred by the quitters. The Bedfont Smokerlyzer and iScreen OFD Cotinine Saliva
      Test Kit will be used for validations. The validation takes very short time (3 minutes ) and
      is easy.

      Sample size determination:

      Our pilot RCT showed that the OR of the CO validated quit rates between the intervention and
      control group was 2.04 (95%CI 0.74-5.65) (Intervention: 26.0%, Control: 15.0%). Because our
      proposed RCT will recruit quitters who have recently quit, PI have conservatively estimated
      that the OR will be 1.70 (23.0% vs 15.0%). To detect a significant difference of quit rate
      with 2-tailed z-test by GPower 3.1 between the two groups with a power of 90% (to reduce type
      II error) and 5% significant level (type I error), 1,008 participantswill be needed in total
      (504 individual per group).

      Data analyses

      Statistical analysis:

      Using intention-to-treat analysis, participants who are lost to follow-up or drop out will be
      treated as smokers with no changes in daily cigarette consumption. The odds ratio, risk
      difference, and 95% confidence interval will be used to compare the primary and secondary
      outcomes between the two trial groups. Number needed to treat (NNT), which shows the number
      of treated participants needed to have one additional quitter at 12-month, will be computed
      by taking the reciprocal of the risk difference between the two trial groups. Assuming the
      missing outcomes are dependent on observed data (missing at random), an analysis using the
      multiple imputation (MI) procedure to impute the missing data will be conducted as
      sensitivity analysis. On the assumption that there will be no heterogeneity of intervention
      effect across clinics, the primary analysis will be conducted using logistic regression with
      and without adjustment for baseline characteristics. The assumption of homogeneity will first
      be checked by testing the clinic by intervention interaction with clinic as a fixed effect in
      the logistic model. If there is evidence of heterogeneity (i.e. p-value < 0.1), an analysis
      by generalized linear mixed (GLM) model with clinic as a random effect will be used to
      summarize the intervention effect on the primary outcome. Number of posts received and posted
      by each participant will be documented, and then included in the final GLM model to assess
      their association with the cessation outcome. All data analysis will be done using IBM SPSS
      version 25.0.

      Text mining of the WhatsApp groups:

      All discussion content will be archived and anonymized to remove identifying personal
      information. Due to a huge number of messages from the 50 WhatsApp groups, an automatic,
      computational text mining and visualization of the dataset will be used for the content
      analysis. First, utilizing a lexicon of keywords derived from our qualitative analysis of the
      pilot RCT, a heatmap visualization will be developed to illustrate the prevalence of the
      discussion topics. Second, topic modelling will be applied to investigate emerging themes in
      our WhatsApp dataset, using the Mallet implementation of the Latent Dirichlet Allocation
      topic modelling algorithm. Topic modelling algorithms take as input a text dataset (in this
      case, the WhatsApp dataset), and output a set of topics (and their associated keywords) in
      addition to estimates of the proportion of each topic.

      Qualitative interview

      To collect opinions towards the WhatsApp group intervention, purposive sampling will be used
      to select 20 individuals from the intervention group including both sexes, all age groups and
      all smoking status at 12-month, to participate in a qualitative face-to-face or telephone
      interview after the intervention. An interview guide with open-ended and iterative questions
      was used to probe for more experiences from the interviewees. Each interview will be
      conducted by the PI and a trained research assistant, and will last about 30 to 60 minutes.

      The interview content was transcribed verbatim in Chinese for further analysis. The
      qualitative interview transcripts will be analysed using framework analysis to construct a
      coherent and logical structure from the classification of many opinions and perceptions of
      social groups. Lead PI and two trained research assistants first used the open-coding method
      to identify relevant content in the transcripts; next, the lead PI will classified all
      labelled content into several independent themes showing distinct features of the social
      groups. The results were then discussed and consolidated in the panel meetings with the Co-I.

      Cost-effectiveness analysis :

      Cost-effectiveness analysis will be undertaken to indicate whether the intervention will be
      more cost-effective or even cost-saving option for a quitter over a time horizon of one year
      (within trial period) and lifetime. Within and lifetime cost-effectiveness analyses will be
      populated based on the healthcare provider perspective.

      Model parameters input will be identified through within trial data and a review of local and
      overseas literature, where necessary. Within trial cost-effectiveness of WhatsApp
      intervention versus control group will be evaluated using total costs, the number of tobacco
      abstinence and total QALYs over the study period. EQ-5D-5L utility data at baseline and
      follow-ups from trial will estimate QALYs in two groups using area under the curve technique.
      Lifetime cost-effectiveness will be performed via Markov modelling that will simulate the
      annual health status progression of subjects in either intervention or control group. Both
      the successful and unsuccessful quitters after the trial will be subject to the annual
      transition probability from a status of no diseases to lung cancer, cardiovascular diseases,
      and other diseases, and then mortality. Former smokers may be relapsed after abstinence.
      Discounting will only be applied to total costs and QALY calculation under the lifetime
      horizon. Sensitivity analyses will be conducted where each parameter will be set at plausible
      lower and upper bounds based on 95% confidence interval of estimates in above data analysis.

      The incremental cost-effectiveness ratio (ICER) in terms of cost per an additional tobacco
      abstinence gained, life-years gained, or QALYs gained for the intervention group in
      comparison to the control group will be reported. The WhatsApp intervention will be
      considered as cost-effective if its ICER will be less than 3 times per capita gross domestic
      product in Hong Kong recommended by WHO or the potential ICER threshold in Hong Kong. The
      cost-effectiveness model will be built using Microsoft Excel or Treeage Pro software.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of Participants Who Passed the Biochemical Validated Abstinence at 12-month Follow-up
time frame: 12 month
description: Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit
measure: Number of Participants Who Passed the Biochemical Validated Abstinence at 6-month Follow-up
time frame: 6 month
description: Exhaled carbon monoxide below 4ppm using a Smokerlyzer, and a saliva cotinine 10ng/ml or below using the iScreen OFD Cotinine Saliva Test Kit
measure: Number of Participants Who Self-reported 7-day Abstinence at 3-month Follow-up
time frame: 3 month
description: Self-reported abstinence in the past 7 days at 3-month follow-up
measure: Number of Participants Self-reported 7-day Abstinence at 6-month Follow-up
time frame: 6 month
description: Self-reported abstinence in the past 7 days at 6-month follow-up
measure: Number of Participants Self-reported 7-day Abstinence at 12-month Follow-up
time frame: 12 month
description: Self-reported abstinence in the past 7 days at 12-month follow-up
measure: Number of Participants Who Reported Smoking Relapse at 3-month Follow-up
time frame: 3 month
description: Consuming 5 cigarettes or more in 3 consecutive days in the past 3 months
measure: Number of Participants Who Reported Smoking Relapse at 6-month Follow-up
time frame: 6 month
description: Consuming 5 cigarettes or more in 3 consecutive days in the past 6 months
measure: Number of Participants Who Reported Smoking Relapse at 12-month Follow-up
time frame: 12 month
description: Consuming 5 cigarettes or more in 3 consecutive days in the past 12 months
measure: Number of Participants Who Reported Self-reported Continuous Abstinence
time frame: 3 month
description: Self-reported continuous abstinence
measure: Number of Participants Who Self-reported Continuous Abstinence
time frame: 6 month
description: Self-reported continuous abstinence
measure: Number of Participants Who Self-reported Continuous Abstinence
time frame: 12 month
description: Self-reported continuous abstinence
measure: Frequency of Smoking Urge
time frame: 3 month
description: Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).
measure: Intensity of Smoking Urge
time frame: 3 month
description: Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).
measure: Frequency of Smoking Urge
time frame: 6 month
description: Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).
measure: Intensity of Smoking Urge
time frame: 6 month
description: Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).
measure: Frequency of Smoking Urge
time frame: 12 month
description: Frequency (in the past week) of smoking urge will be evaluated according to their frequency of their smoking urges on a scale of 0 (none at all) to 4 (ever hour or more).
measure: Intensity of Smoking Urge
time frame: 12 month
description: Intensity (in the past day) of smoking urge will be evaluated according to their intensity of their smoking urges on a scale of 1 (never have smoking urges) to 5 (smoking urges every hour or more).
measure: EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
time frame: 3 month
description: EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).
measure: EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
time frame: 6 month
description: EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).
measure: EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
time frame: 12 month
description: EuroQol 5-dimension 5 level (EQ-5D-5L) health utility scores on a 1 (No problem) -5 (unable or extreme pain/ anxious) scales which assess participants mobility, self care, usual activities, pain/ discomfort and their anxiety/ depression. After obtaining the data, results were re-calculated and transferred based on Hong Kong population norm. After calculation, the total score ranged from -0.864 to 1. Higher score indicates better health status. Calculations of this scale were based on Hong Kong population provided by Wong EL and colleagues (Wong EL, Ramos-Goni JM, Cheung AW, Wong AY, Rivero-Arias O. Assessing the use of a feedback module to model EQ-5D-5L health states values in Hong Kong. The Patient-Patient-Centered Outcomes Research. 2018 Apr;11(2):235-47.).
measure: Change in Quality of Life Inventory
time frame: 6 month
description: Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family.
measure: Change in Quality of Life Inventory
time frame: 12 month
description: Quality of Life Inventory (QoLI) , 7 items with 3-point rating scale for importance (1 not important, 3 very important), and 3-point rating scale for satisfaction (1 not satisfied, 3 very satisfied) in terms of health, economy, work, hobbies, relationship with partner, friendship and relationship with family.
measure: Nicotine Withdrawals
time frame: 3 month
description: Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.
measure: Nicotine Withdrawals
time frame: 6 month
description: Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.
measure: Nicotine Withdrawals
time frame: 12 month
description: Minnesota Nicotine Withdrawal Scale (MNWS) using Likert-type scale for the severity ratings, ranging from 0 (not at all) to 4 (severe) in terms of their desire and craving to smoke, insomnia, awakening at night, difficulty in concentration, anxious,depressed, restless and irritable. As the 9 items were rated from 0-4, therefore, the total score ranged from 0-36. A higher score indicates participants had more withdrawal symptoms.
arm group label: Intervention
arm group type: Experimental
description: WhatsApp group will receive at least 3 messages each week and allow real-time group discussion for the intervention period (8 weeks).
arm group label: Control
arm group type: Active Comparator
description: The control group will receive 3 mobile phone text messages each week in the 8 weeks after recruitment. This will be a one way message and no real-time discussion will be available.
intervention type: Other
intervention name: WhatsApp group
description: WhatsApp group will allow real-time group discussion for 8 weeks
arm group label: Intervention
intervention type: Other
intervention name: SMS group
description: SMS group for 8 weeks
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Hong Kong
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PMID: 26928205
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responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Derek Yee-Tak Cheung
investigator title: Research Assistant Professor
mesh term: Recurrence
sharing ipd: Yes
ipd description: Research data and documentation will be available upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 3 years
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 