1. ASSIST study: Ambulant Study of Smoking habIt based on phySiological and conTextual pattern

This ASSIST study is part of the imec and KU Leuven research on smoking habit modeling. In the current experiment, the aim is to study the behavior and precursors of smokers through contextual (location, movement, schedule) and physiological (skin conduction, heart rate) information, and to search for indicative patterns for smoking urges. The ultimate goal of the whole project is to build up a virtual coach based on the discoveries found in this experiment to assist smokers give up smoking. This coach/model is able to learn your smoking habit, predict smoking urges and intrigue tailored feedbacks.
To develop such a model that is widely applicable we need a large and diverse sample size. We want to recruit 100 daily smokers in this innovative research and therefore we need your help. We invite you to participate in our study. Below you will find general information. On the Benefits session you will find information about what is in it for you. If you want to participate you can go to the page Participate and subscribe for the study. You will be able to choose the period when you want to participate and you will be given further practical information. Before you make any decision, please first read the information below.

2. Inclusion/exclusion criteria

In this experiment, we will use the following criteria to screen the participants from candidates.
ItemExplanation
Inclusion criteria
  1. Healthy participants
  2. Daily smokers who consume only boxed cigarettes or roll-your-own cigarettes regularly in the past one year.
  3. Similar amount of males and female smokers with a diverse background (i.e. race, smoking history, marital status)
  4. An age-group that represents the average working population ranging from 18 to 65 years old.
  5. Full-time office workers with different functions (e.g. managers, researchers, secretaries, )
Exclusion criteria
  1. Pregnancy
  2. Unemployment or part-time workers
  3. Subjects with hazardous conditions (e.g. pacemakers or any other implanted devices).
  4. Health problems, both physical and psychological, that cause an employee to live in abnormal lifestyle or need to change their smoking behaviour.
  5. Active jobs e.g. construction workers

3. Course of the study

The whole study consists of three coherent stages. They are preliminary stage, the experiment and a follow-up respectively.
StagesTimingParticipant
Preliminary phase1 month in advance-Subscribe on the website, choose when to participate, fill out screen questions
Monday morning of the first experiment week-Email reminder to read through an informed consent form on the website, get it printed out and signed, fill out an intake questionnaire.
ExperimentDay 0 (Start date): Tuesday in the first weekTuesday morning between 8-10am participants come to the experimental office to
- Check their registered id
- Hand in consent form or signed it at the site
- Take the expired CO level test
- Pick up sensor package
- Then the experiment starts, participants need to put on all wearables and do the full day annotation in the smartphone App.
Day 1 to day 6Participants are required to wear the wearable sensors and do the full day annotation in the smartphone App.
Day 7 (Middle day): Tuesday in the second week- Participants will receive email reminder to recharge sensors.
- During the daytime, participants are required to wear the wearable sensors and do the full day annotation in the smartphone App.
- At night they need to take off the sensors and recharge them all.
Day 8 to day 13participants are required to wear the wearable sensors and do the full day annotation in the smartphone App.
Day 14 (last day): Tuesday in the third week- Full out pop-ups in smartphone App
- Fill out a feedback questionnaire on the website
- Survey on desire to participate in smoking cessation about one year later
- Take the expired CO level test and return sensor package in the afternoon
Large scale experiment for smoking cessation1 year later follow- upRecruit those participants desire to take part in follow-up smoking cessation experiment

During the preliminary phase participants will be recruited and pre-screened. Participants will be able to register on the website. On Monday in the week of the experiment the participants will receive an automatic generated e-mail that invites them to go over an informed consent form, which they need to get it printed out and signed. The first contact (the baseline assessment) take place at their selected certain Tuesday morning when participants are first required to do an expired CO level test using Smokerlyzer. Normally the CO level among non-smokers is around 1~3 ppm, while it usually exceeds 10 ppm among daily smokers. Then they will collect the sensors.
For every participant a sensor package will be prepared. This package contains:

  • A chest patch
  • A wristband
  • A smart lighter, to be used by the participant in place of their lighter
  • A smartphone, depending on whether the participant wants to put the application on his own smartphone or use another one (smartphone include App for smoke/daily survey pop-ups, and track the participant's location/environmental sound/temperature/light)
  • A user manual with a detailed explanation of the sensors/application and contact persons in case of a problem.
  • A usb-stick with all the information + a short info movie
Chest patch and wristband should be worn by the participants also during the night, they should be removed: 1) during shower, 2) during the night in which they need to be charged, 3) if irritation or discomfort experienced by the participants (in this case the participant should get in contact with the experimenter as soon as possible).
Every sensor will have its own label. The unique label of the sensor and of the participant will be stored in order to match sensors and participants.
Then the experiment starts. The participant will have to follow the instructions from the user manual. The experiment will take place from Tuesday morning and last for two weeks. The weekend is included to investigate the differences between a weekend and a working day. The smartphone will send alarms when the participant has to fill out the annotation questions. During the experiment the goal is to measure ad lib smoking habits during daily life, therefore no interventions nor will feedback take place.


4. Privacy

To protect your privacy, several measures are taken:
The first measure is the de-identification of all the data. To fill out the online surveys, you will need to create a personal account. This account will automatically assign a unique identifying code that is also used in the mobile application. Furthermore all sensors will contain a number which will be linked to your identifying code, no personal information is used to link sensors to surveys and annotations. The provided e-mail addresses, that will be used to send reminders and practical information, will be stored in a secure database separate from the data entered into assessments.
The second measure is secure data storage. All data collected will be encoded and encrypted before being pushed to the cloud-based storage database. Access to the databases will be gated so entry is only permitted to users entering through the approved route. Finally there will be no possibility for unauthorized data access since a password will be needed to access the data.

5. Informed consent

This study is approved by the Ethical Commission of the UZ Leuven. Before the start of the experiment you will need to sign an informed consent. This can be downloaded here: Informed consent
If you want to participate please read it thoroughly, print it out, sign it and take it with you when you collect the sensors. If you have any further questions you can contact the researcher (see contact information).
For the retrieval of context information through your smartphone, additional approval will be asked on the application. If you decline, the smartphone will not collect this information and the phone will only be used for annotation.

6. Contact information

If you need further information, but also if you have problems or concerns, you can contact the investigator Smets Elena on the following telephone number 016 28 77 54 or e-mail address eric.zhai@imec.be
In case of a medical emergency, you can contact Premed and ask for Luc Hons on the following telephone number 016 30 81 11. Please mention you call concerning the ASSIST study of Eric Zhai.

7. Benefits

By taking part in this study, though you may not derive any immediate personal benefits, the data you have contributed could potentially help to make a big difference in facilitating people’s awareness and controllability over the smoking addiction, thus improving the wellness of human being as a whole.
As a small additional incentive for your participation, we will provide some restaurant coupons or vouchers to participants as a reward for their time and effort. At the same time, in order to increase participants’ adherence during the experiment, they will have different chances to win the reward based on their involvement in this experiment. Specifically, every time they finish a self-report, they will improve their chances to win.

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