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The study aims to (1) evaluate the effectiveness of the recent renewal of tobacco health warnings (HWs) on noticing and anti-smoking responses, and (2) assess the effect of exposure to point-of-sale (POS) tobacco displays and smoking hotspots on nicotine-craving intensity and smoking-related behaviors. The study will use time-based system-triggered ecological momentary assessments to collect real-time data about exposures to smoking-related cues and behaviors. With a smartphone app installed in the mobile phones of the participants, they will each day complete at least 3 pairs of EMA prompted randomly for only 2 days (a working and a nonworking day). Outcomes include exposure and responses to tobacco HWs, exposure to POS tobacco displays, exposure to smoking hotspots and smoking and quitting outcomes.
To protect the privacy of the participants, several strategies will be adopted. First, participants will be reassured that all data are anonymous in the data collection and the analysis. All data will not be accessed by the clinic counselors. Second, no personal data (e.g. name and telephone numbers) will be collected in the app.
The EMA validity largely relies on the participants' compliance, therefore an attractive incentive is needed. If they complete all the EMAs in the 2-day period, they will be given HK$200 dollar.
After the data collection, the participants will be reminded to uninstall the app. They will be contacted to receive the incentive and complete the last questionnaire face-to-face.
3 . EMA app The EMA app will be developed based on the app used in our aforementioned pilot randomized trial, which has a user-friendly interface and is easily operated. Users need to input at least 3 time windows (each for at least an hour) in each study day. In each time window, the app will firstly prompt the user at a random time to answer a set of questionnaire in the app, including questions on (1) exposure and responses to tobacco HW, (2) exposure to tobacco POS displays, (3) exposure to smoking hotspots, and (4) smoking and quitting outcomes. After 30 minutes of completing the first questionnaire, the app will prompt again the user to answer another set of questionnaire, which only assess smoking and quitting outcomes. The design of EMA pair within 30 minutes facilitates the analysis of causality, because we can capture some smoking or cravings preceded by the environmental exposures. Each questionnaire will take no more than 1 minute to complete. If an EMA prompt is not responded by the user, 2 additional prompts in every 5 minutes will be generated to remind the user to complete. The EMA will regard non-response as missing data if these additional prompts are not responded. All the above data will be sent to our server in each day.
4. Statistical analysis Data will be analyzed with SPSS or Stata for Windows. The first research question can be addressed by comparing the frequency/proportion of the 4 HW-related outcomes pre- and post-implementation of the new warnings. To take into account the clustering between the outcomes within each participant, generalized estimating equation model will be used to assess the effect of new HWs on the noticing and responses to the HWs. To answer the second and third research questions, each EMA pair is the analysis unit, which is nested within each participant. The 3 outcome variables include the craving intensity (continuous variable), purchase of tobacco (binary) and smoking (binary). In the main analysis, linear mixed model (continuous) and mixed logistic regression model (binary) which allow for multiple observations in each subjects and account for clustering of data within subjects will be used to explore the association between each exposure variable and the outcome variables, adjusted for the variables collected at baseline. Significance level will be defined as p<0.05.
5. Consent Participation in the study is voluntary. The recruitment staff will explain to the potential subjects who agree to join the study, before the written consent is requested. The subjects will be assured that they can withdraw from the study anytime without any prejudice, and all the information will be kept confidential and results will be reported in an aggregate format. Subjects are required to sign the written consent form.
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| Measure | Description | Time Frame |
|---|---|---|
| Exposure and responses to tobacco HWs | The question set includes (1) whether he/she has noticed tobacco HWs in the past 2 hours (yes/no), (2) whether he/she has thought of the harms of smoking due to the HWs (yes/no), (3) whether he/she has thought of quitting due to the HWs (yes/no), and (4) whether he/she has forgone cigarettes due to PWs (yes/no). All items will be re-assessed in the later waves of EMA data collection. | 2 hours |
| Exposure to POS tobacco displays | The question set includes (1) whether he/she has entered into any retail shops selling tobacco in the past hour (e.g. 7-11, OK) (yes/no), (2) if he/she has noticed tobacco POS displays in those retail shops in the past 2 hours (yes/no), and (3) in what extent he/she perceive the displays as attractive (5-point scale). | 2 hours |
| Exposure to smoking hotspots | The question set includes (1) whether he/she has witnessed a group of smokers (at least 3 smokers) smoking at one specific outdoor area nearby a rubbish bin in the past 2 hours (yes/no), (2) if yes, whether he/she was within 3 meters of such "cluster" of smokers and (3) whether he/she has smoked at these places in the past hour (yes/no). | 2 hours |
| Smoking and quitting outcomes | The question set includes (1) the craving intensity in the past half hour (no craving, mild, fair, heavy, very heavy), (2) whether he/she has bought tobacco in the past half hour (yes/no), (3) whether he/she has smoked in past half hour (yes/no) and (4) whether the above responses have been due to the exposure to POS tobacco displays and/or smoking hotspots. | half an hour |
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Inclusion criteria
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The study targets to recruit 300 smokers, who will be from smoking cessation clinic (150), outside the retail shops selling tobacco (75), and smoking hotspots (75). All smoking cessation clinics under Tung Wah Group of Hospitals, Pok Oi Hospitals and Hospital Authority will be included. The recruited smokers in these clinics are ready to quit, which are more responsive to cue-induced cravings than other smokers. Smokers who are less ready to quit will be recruited from retail shops and smoking hotspots. These sites will be carefully selected for better recruitment.
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| Name | Affiliation | Role |
|---|---|---|
| Derek Derek | Tung Wah Group of Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | 00 | Hong Kong |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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