Smoking CessationNCT04037696
Using a General Health Promotion Approach to Help Smokers With Chronic Diseases Quit
A study testing General Health Promotion Approach in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to evaluate the effectiveness of a general health promotion (GHP) approach to motivate smokers with chronic diseases to quit smoking. Subjects in the intervention group will receive a brief Motivational Interviewing (MI) using a GHP approach. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- General Health Promotion Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Jul 2019to 26 Dec 2020
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or above,
- able to speak Cantonese and read Chinese
- no intention to quit smoking (pre-contemplation stage), but are willing to take action to promote health
- have a smart phone and able to use instant messaging tool (e.g. WhatsApp, WeChat) for communication, and
- willing to receive health promotion advices via WhatsApp/WeChat in the smart phone throughout the study
Who cannot join
- unable to give informed consent or participate in our intervention due to impaired mental status, cognitive impairment, or communication barrier, and
- participation in other smoking cessation programmes or services
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Ho Cheung William Li, PhD
Ho Cheung William Li, PhD
About this study
Official title: Using a General Health Promotion Approach to Help Smokers With Chronic Diseases Quit: A Randomised Controlled Trial
This study aims to evaluate the effectiveness of a general health promotion (GHP) approach to motivate smokers with chronic diseases to quit smoking. Subjects in the intervention group will receive a brief Motivational Interviewing (MI) using a GHP approach. Subjects in the control group will receive a self-help booklet on smoking cessation at the time of recruitment.
Read the detailed description
Smoking has harmful effects on nearly every organ of the body and causes seven million deaths worldwide every year. Although the prevalence of daily cigarette smoking in Hong Kong has decreased from 23.3% in 1982 to 10.5 % in 2015, there are still 641,300 daily smokers and 400,000 hospitalisations per year that are attributable to smoking. Having a disease and requiring medical attention present an excellent 'teachable moment' and opportunity for initiating smoking cessation in patients, because they will be more likely to be motivated to alter their habits and improve their health. However, cigarette smoking is addictive and quitting is very difficult, with a high rate of relapse, particularly among patients with chronic diseases.
During the past decade, the investigators have conducted several trials on promoting smoking cessation to smokers with chronic diseases, including cardiac, type 2 diabetes mellitus, and cancer. It is found that many smokers with chronic diseases had a long smoking history, high nicotine dependency, no quit attempt, and no intention to quit. Results of these studies indicated that about 68% smokers with cardiac diseases, 70% with diabetes mellitus and 73% with cancer recruited in Special Out-Patient Clinics (SOPC) were still in the pre-contemplation stage. This revealed that most Hong Kong smokers with chronic diseases perceived more barriers in quitting than the benefits of quitting. Nevertheless, our previous smoking cessation interventions mostly focused on using brief interventions including stage-matched smoking cessation advice. Such interventions could be too brief and inadequate to make a great impact on such smokers. Moreover, the investigators found that using strong warnings to communicate the risk of continued smoking might not be accepted by some of them. Hence, the investigators need to develop and evaluate a more innovative intervention to enhance the effectiveness in promoting smoking cessation for smokers with chronic diseases. Most importantly, the new strategy should have a good potential implementation in many clinical settings.
Smoking has been found to be associated with physical inactivity, unhealthy diet, and drinking. The interrelationship of health behaviours suggests that there could be a higher level of attribute that determines such behaviours together. Our previous studies showed that people with a general intention to promote their health are more likely to engage in desirable health-related lifestyle practices. In addition, research results showed that people once engaged in any desirable health-related lifestyle practices would progressively move to later stages of change for other health behaviours. Based on this concept, a general health promotion approach will be used to motivate smokers with intention to promote health to first engage in any desirable health-related lifestyle practices that are chosen by individual smokers, such as regular physical activity and healthy diet. It is anticipated that once they are engaged in any desirable health-related lifestyle practice they will eventually be more motivated to quit smoking.
- Conditions
- Smoking Cessation
- Being tested
- General Health Promotion Approach, Control
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Health Promotion ApproachBehavioural
The trained Research assistants will ask the subjects about the priority of engaging in any desirable health-related lifestyle practice as identified in the completed baseline questionnaires and to state a targeted goal that they perceive as the easiest to achieve. Each subject will then receive an individual face-to-face brief MI (about 5 mins) with generic health advice on selected health-related lifestyle practice. They will then be informed to receive an individual brief MI intervention to assist behavioural changes or achieve goals as desired or chosen by them via WeChat or WhatsApp in smart phones throughout the study period.
The RA will then deliver brief MI to each subject individually via WeChat or WhatsApp in smart phones throughout the study period.
Readiness of quitting smoking will be assessed at 3-month follow-up. Upon request by subjects, we shall provide them with more comprehensive information on quitting.
ControlBehavioural
The subjects will be given general brief advice and a self-help smoking cessation booklet with Hotline (Tel.: 1833183). However, subjects in the control group will not receive brief MI and follow-up booster intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will receive individual face-to-face brief MI (about 5 minutes) on a health-related lifestyle practice. The experimental group will then receive a brief MI via WhatsApp/WeChat on a smartphone during the study period. The brief MI messages will be delivered more intensively as preferred by the subject (usually not less than once every 2 to 3 days and no more than 2 times per day) for the first 6 months. The frequency of delivering the messages via WhatsApp/WeChat will be interactive, depending on the subjects' actions and responses, and may take several sessions of chats within several days or weeks. After 6 months, minimal messages will be provided to the subjects by merely following their progress of behavioural changes and responding to their questions to maintain contact until the 1-year follow-up. Receives: Behavioral: General Health Promotion Approach |
| Control group | Other | The control group will be given general brief advice and receive a self-help booklet on smoking cessation published by the Hong Kong Council on Smoking and Health with Hotline will be also provided in the SOPCs. The subjects in this group will receive the same schedule of follow-ups as in the intervention group, but they will not receive any follow-up booster intervention. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated smoking abstinence at 6 months
The biochemically validated smoking abstinence will be confirmed by a saliva cotinine level of less than 115 ng/ml in parallel test and a carbon monoxide level in expired air of less than 9 parts per million (ppm)
Measured: 6-month follow-up
Secondary outcomes (5)
biochemically validated smoking abstinence at 12 months
The biochemically validated smoking abstinence will be confirmed by a saliva cotinine level of less than 115 ng/ml in parallel test and a carbon monoxide level in expired air of less than 9 parts per million (ppm)
Measured: 12-month follow-up
Self-reported 7-day point prevalence of smoking abstinence at 6 and 12 months
A structured questionnaire will be developed by adopting or modifying international and/or locally validated instruments.
Measured: 6- and 12-month follow-up
Behavioural change
A structured questionnaire will be developed by adopting or modifying international and/or locally validated instruments.
Measured: 3-, 6- and 12-month follow-ups
Smoking quit attempt change from baseline
A structured questionnaire will be developed by adopting or modifying international and/or locally validated instruments.
Measured: 3-, 6- and 12-month follow-ups
Smoking reduction rate change from baseline
A structured questionnaire will be developed by adopting or modifying international and/or locally validated instruments.
Measured: 3-, 6- and 12-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start30 Jul 2019
- Primary completion26 Dec 2020 (estimated)
- Study completion26 Dec 2020 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung William Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037696
- Sponsor's protocol ID
- NTWCREC19001-Main
- Status last verified
- Nov 2020
- First submitted
- 26 Jul 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 General Health Promotion Approach to Help Smokers With Chronic Diseases Quit: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04037696
- Acronym / sponsor ID
- NTWCREC19001-Main
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 26 Dec 2020 (estimated)
- Study completion
- 26 Dec 2020 (estimated)
- First posted
- 30 Jul 2019 (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 study aims to evaluate the effectiveness of a general health promotion (GHP) approach to motivate smokers with chronic diseases to quit smoking. Subjects in the intervention group will receive a brief Motivational Interviewing (MI) using a GHP approach. Subjects in the control group will receive a self-help booklet on smoking cessation at the time of recruitment.
Detailed description
Smoking has harmful effects on nearly every organ of the body and causes seven million deaths worldwide every year. Although the prevalence of daily cigarette smoking in Hong Kong has decreased from 23.3% in 1982 to 10.5 % in 2015, there are still 641,300 daily smokers and 400,000 hospitalisations per year that are attributable to smoking. Having a disease and requiring medical attention present an excellent 'teachable moment' and opportunity for initiating smoking cessation in patients, because they will be more likely to be motivated to alter their habits and improve their health. However, cigarette smoking is addictive and quitting is very difficult, with a high rate of relapse, particularly among patients with chronic diseases.
During the past decade, the investigators have conducted several trials on promoting smoking cessation to smokers with chronic diseases, including cardiac, type 2 diabetes mellitus, and cancer. It is found that many smokers with chronic diseases had a long smoking history, high nicotine dependency, no quit attempt, and no intention to quit. Results of these studies indicated that about 68% smokers with cardiac diseases, 70% with diabetes mellitus and 73% with cancer recruited in Special Out-Patient Clinics (SOPC) were still in the pre-contemplation stage. This revealed that most Hong Kong smokers with chronic diseases perceived more barriers in quitting than the benefits of quitting. Nevertheless, our previous smoking cessation interventions mostly focused on using brief interventions including stage-matched smoking cessation advice. Such interventions could be too brief and inadequate to make a great impact on such smokers. Moreover, the investigators found that using strong warnings to communicate the risk of continued smoking might not be accepted by some of them. Hence, the investigators need to develop and evaluate a more innovative intervention to enhance the effectiveness in promoting smoking cessation for smokers with chronic diseases. Most importantly, the new strategy should have a good potential implementation in many clinical settings.
Smoking has been found to be associated with physical inactivity, unhealthy diet, and drinking. The interrelationship of health behaviours suggests that there could be a higher level of attribute that determines such behaviours together. Our previous studies showed that people with a general intention to promote their health are more likely to engage in desirable health-related lifestyle practices. In addition, research results showed that people once engaged in any desirable health-related lifestyle practices would progressively move to later stages of change for other health behaviours. Based on this concept, a general health promotion approach will be used to motivate smokers with intention to promote health to first engage in any desirable health-related lifestyle practices that are chosen by individual smokers, such as regular physical activity and healthy diet. It is anticipated that once they are engaged in any desirable health-related lifestyle practice they will eventually be more motivated to quit smoking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: General Health Promotion ApproachThe experimental group will receive individual face-to-face brief MI (about 5 minutes) on a health-related lifestyle practice. The experimental group will then receive a brief MI via WhatsApp/WeChat on a smartphone during the study period. The brief MI messages will be delivered more intensively as preferred by the subject (usually not less than once every 2 to 3 days and no more than 2 times per day) for the first 6 months. The frequency of delivering the messages via WhatsApp/WeChat will be interactive, depending on the subjects' actions and responses, and may take several sessions of chats within several days or weeks. After 6 months, minimal messages will be provided to the subjects by merely following their progress of behavioural changes and responding to their questions to maintain contact until the 1-year follow-up. |
| Control group | Other | Behavioral: ControlThe control group will be given general brief advice and receive a self-help booklet on smoking cessation published by the Hong Kong Council on Smoking and Health with Hotline will be also provided in the SOPCs. The subjects in this group will receive the same schedule of follow-ups as in the intervention group, but they will not receive any follow-up booster intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 18 years or above,
- able to speak Cantonese and read Chinese
- no intention to quit smoking (pre-contemplation stage), but are willing to take action to promote health
- have a smart phone and able to use instant messaging tool (e.g. WhatsApp, WeChat) for communication, and
- willing to receive health promotion advices via WhatsApp/WeChat in the smart phone throughout the study
Key exclusion criteria (2 listed)
- unable to give informed consent or participate in our intervention due to impaired mental status, cognitive impairment, or communication barrier, and
- participation in other smoking cessation programmes or services
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 |
|---|---|---|
| General Health Promotion ApproachThe trained Research assistants will ask the subjects about the priority of engaging in any desirable health-related lifestyle practice as identified in the completed baseline questionnaires and to state a targeted goal that they perceive as the easiest to achieve. Each subject will then receive an individual face-to-face brief MI (about 5 mins) with generic health advice on selected health-related lifestyle practice. They will then be informed to receive an individual brief MI intervention to assist behavioural changes or achieve goals as desired or chosen by them via WeChat or WhatsApp in smart phones throughout the study period. The RA will then deliver brief MI to each subject individually via WeChat or WhatsApp in smart phones throughout the study period. Readiness of quitting smoking will be assessed at 3-month follow-up. Upon request by subjects, we shall provide them with more comprehensive information on quitting. | Behavioural | Experimental group |
| ControlThe subjects will be given general brief advice and a self-help smoking cessation booklet with Hotline (Tel.: 1833183). However, subjects in the control group will not receive brief MI and follow-up booster intervention. | Behavioural | Control group |
Primary outcome
Biochemically validated smoking abstinence at 6 months
Time frame: 6-month follow-up
The biochemically validated smoking abstinence will be confirmed by a saliva cotinine level of less than 115 ng/ml in parallel test and a carbon monoxide level in expired air of less than 9 parts per million (ppm)
5 secondary outcomes
biochemically validated smoking abstinence at 12 months
Time frame: 12-month follow-up
Self-reported 7-day point prevalence of smoking abstinence at 6 and 12 months
Time frame: 6- and 12-month follow-up
Behavioural change
Time frame: 3-, 6- and 12-month follow-ups
Smoking quit attempt change from baseline
Time frame: 3-, 6- and 12-month follow-ups
Smoking reduction rate change from baseline
Time frame: 3-, 6- and 12-month follow-ups
Results and safety
Results are not available in the source record.
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 William 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?
A study testing General Health Promotion Approach in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 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: status not confirmed, 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho Cheung William Li, PhD (+85239176634, william3@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated smoking abstinence at 6 months (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.