Smoking CessationNCT03718169
Smartphone Application-based Smoking Cessation Programme Among Female Smokers
An observational study of Smoking Cessation, run by The University of Hong Kong at 1 site in China.
Trial summary
This project aims to develop a smartphone application to deliver a gender-specific programme for female smokers in Hong Kong. Through the smartphone application, we expect that our gender-specific smoking cessation programme can reach more female smokers in Hong Kong. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2019to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hong Kong female smokers.
Who may be able to join
- Hong Kong female resident aged 18 or above
- Able to communicate in Chinese (Cantonese)
- Current Smokers
Who cannot join
- Have difficulty to communicate via telephone
- Having queries irrelevant to tobacco control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using a Smartphone Application to Deliver a Gender-specific Smoking Cessation Programme Among Female Smokers in Hong Kong
This project aims to develop a smartphone application to deliver a gender-specific programme for female smokers in Hong Kong. Through the smartphone application, we expect that our gender-specific smoking cessation programme can reach more female smokers in Hong Kong. The objectives is to promote smoking cessation among female smokers in Hong Kong.
Read the detailed description
This is a one-year project, and it will be divided into 2 Phases. Phase I will focus on translating our gender-specific smoking cessation programme into a smartphone application. In Phase II, the investigators will promote the smartphone application to female smokers in the community.
Phase I: Translating our gender-specific smoking cessation programme into a smartphone application To translate our gender-specific smoking cessation programme into a smartphone application, an expert panel will be formed. The panel members include a chair professor, an associate professor, an assistant professor, a research assistant professor and a postdoctoral fellow, with all of whom have considerable experience in conducting studies on smoking cessation and tobacco control. The content of the smartphone application will be designed according to the gender-specific smoking cessation programme delivered by our women Quitline. In particular, the smartphone application aims to help female smokers abstain from cigarettes by their readiness to quit. For female smokers who are in the pre-contemplation or contemplation stage, the smartphone application will motivate them to quit by instructing them to list out the reasons for quitting, and providing them information about the damaging effects of smoking on health, especially those are specific to women. Regarding female smokers in the preparation stage, the smartphone application will assist them to individualize their own quit plan by computerized instructions, and provide generic tips how they can achieve abstinence step-by-step. Concerning female smokers in the action stage, skills for overcoming cigarette craving and withdrawal symptoms will be presented. In addition, hazardous effects of smoking will pop-up in their smartphones to remind them of smoking cessation throughout their quitting process. To address the needs and concerns of female smokers, gender-specific elements have been integrated into the smartphone application. In particular, the smartphone application will correct their misconceptions that smoking can be a method to control body weight and manage stress. At the same time, the smartphone application will display information about proper weight-loss strategies and relaxation techniques. Female smokers who need more intensive counseling can also contact our Quitline via the smartphone application.
Phase II: Promoting the smartphone application for female smokers in the community In order to promote the smartphone application for female smokers, the investigators plan to recruit 30 students from the University of Hong Kong to join this project. All recruited students will be invited to participate in a 1-day training workshop organized by our team. During the training workshop, the students will be educated on smoking hazards, the basic principles of smoking cessation and tobacco control policies.
Female smokers will be recruited in smoking hotspots where rubbish bins with a collector of cigarette butts are nearby. The trained university students will approach female smokers at the smoking hotspots, and deliver a small souvenir to them. The souvenir is a pack of tissue paper, with its packaging containing smoking cessation messages and the QR code of the smartphone application. If the smokers accept the souvenir, the students will then introduce this project. For female smokers who are interested to join, the students will assist them to download the smartphone application, briefly go through its content, and encourage them to use it. To remind the female smokers to continuously use the smartphone application for smoking cessation, warning messages about the hazardous effects of smoking will pop up weekly in their smartphones.
- Conditions
- Smoking Cessation
- Being tested
- questionnaires
- Keywords
- women
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
Female smokers will be asked to complete a structured questionnaire at smoking hotspots. In addition, the smokers will respond to the same questionnaire at 6 months via telephone. The structured questionnaire will collect information related to their demographic characteristics and quitting behaviors, i.e. self-reported abstinence, smoking reduction and quit attempts.
| Study group | Role | What they receive |
|---|---|---|
| Hong Kong female smokers | Hong Kong female smokers will be invited to fill in questionnaires about their current smoking situation and quit intention. Receives: Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-days point prevalence smoking abstinence at 6-month
7-days point prevalence smoking abstinence is measured at 6-month. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self-reported smoking abstinence at 6-month.
Measured: 6-month follow-up
Secondary outcomes (1)
Bio-chemical validated smoking abstinence at 6-month
Bio-chemical validated smoking abstinence is measured at 6-month. The participants who claim to have quitted smoking for at least 7 days are invited for biochemical validation (measurement of saliva cotinine level and exhaled carbon monoxide level) at 6-month. The participants are need to get the results of CO≤ 4ppm, and continine level ≤30 ng/ml as passing results.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start3 Jun 2019
- Primary completion12 Jun 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. LI William Ho Cheung, The University of Hong Kong
- Investigators
- Ho-Cheung Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718169
- Sponsor's protocol ID
- KE funding
- Status last verified
- Jun 2020
- First submitted
- 26 Aug 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Smartphone Application to Deliver a Gender-specific Smoking Cessation Programme Among Female Smokers in Hong Kong
- ClinicalTrials.gov ID
- NCT03718169
- Acronym / sponsor ID
- KE funding
- Conditions
- Smoking Cessation
- Keywords
- women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to develop a smartphone application to deliver a gender-specific programme for female smokers in Hong Kong. Through the smartphone application, we expect that our gender-specific smoking cessation programme can reach more female smokers in Hong Kong. The objectives is to promote smoking cessation among female smokers in Hong Kong.
Detailed description
This is a one-year project, and it will be divided into 2 Phases. Phase I will focus on translating our gender-specific smoking cessation programme into a smartphone application. In Phase II, the investigators will promote the smartphone application to female smokers in the community.
Phase I: Translating our gender-specific smoking cessation programme into a smartphone application To translate our gender-specific smoking cessation programme into a smartphone application, an expert panel will be formed. The panel members include a chair professor, an associate professor, an assistant professor, a research assistant professor and a postdoctoral fellow, with all of whom have considerable experience in conducting studies on smoking cessation and tobacco control. The content of the smartphone application will be designed according to the gender-specific smoking cessation programme delivered by our women Quitline. In particular, the smartphone application aims to help female smokers abstain from cigarettes by their readiness to quit. For female smokers who are in the pre-contemplation or contemplation stage, the smartphone application will motivate them to quit by instructing them to list out the reasons for quitting, and providing them information about the damaging effects of smoking on health, especially those are specific to women. Regarding female smokers in the preparation stage, the smartphone application will assist them to individualize their own quit plan by computerized instructions, and provide generic tips how they can achieve abstinence step-by-step. Concerning female smokers in the action stage, skills for overcoming cigarette craving and withdrawal symptoms will be presented. In addition, hazardous effects of smoking will pop-up in their smartphones to remind them of smoking cessation throughout their quitting process. To address the needs and concerns of female smokers, gender-specific elements have been integrated into the smartphone application. In particular, the smartphone application will correct their misconceptions that smoking can be a method to control body weight and manage stress. At the same time, the smartphone application will display information about proper weight-loss strategies and relaxation techniques. Female smokers who need more intensive counseling can also contact our Quitline via the smartphone application.
Phase II: Promoting the smartphone application for female smokers in the community In order to promote the smartphone application for female smokers, the investigators plan to recruit 30 students from the University of Hong Kong to join this project. All recruited students will be invited to participate in a 1-day training workshop organized by our team. During the training workshop, the students will be educated on smoking hazards, the basic principles of smoking cessation and tobacco control policies.
Female smokers will be recruited in smoking hotspots where rubbish bins with a collector of cigarette butts are nearby. The trained university students will approach female smokers at the smoking hotspots, and deliver a small souvenir to them. The souvenir is a pack of tissue paper, with its packaging containing smoking cessation messages and the QR code of the smartphone application. If the smokers accept the souvenir, the students will then introduce this project. For female smokers who are interested to join, the students will assist them to download the smartphone application, briefly go through its content, and encourage them to use it. To remind the female smokers to continuously use the smartphone application for smoking cessation, warning messages about the hazardous effects of smoking will pop up weekly in their smartphones.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hong Kong female smokers | – | Behavioral: questionnairesHong Kong female smokers will be invited to fill in questionnaires about their current smoking situation and quit intention. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hong Kong female smokers.
Key inclusion criteria (3 listed)
- Hong Kong female resident aged 18 or above
- Able to communicate in Chinese (Cantonese)
- Current Smokers
Key exclusion criteria (2 listed)
- Have difficulty to communicate via telephone
- Having queries irrelevant to tobacco control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesFemale smokers will be asked to complete a structured questionnaire at smoking hotspots. In addition, the smokers will respond to the same questionnaire at 6 months via telephone. The structured questionnaire will collect information related to their demographic characteristics and quitting behaviors, i.e. self-reported abstinence, smoking reduction and quit attempts. | Behavioural | Hong Kong female smokers |
Primary outcome
7-days point prevalence smoking abstinence at 6-month
Time frame: 6-month follow-up
7-days point prevalence smoking abstinence is measured at 6-month. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self-reported smoking abstinence at 6-month.
1 secondary outcome
Bio-chemical validated smoking abstinence at 6-month
Time frame: 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Cheung Li, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-days point prevalence smoking abstinence at 6-month (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.