Smoking CessationNCT02755740
Promoting Smoking Cessation for Female Smokers in Hong Kong Through Training Female Youth SCRA
A study testing receiving age and gender-specific SC advice in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.
Trial summary
This project aims to promote quitting, and reduction for those who do not want to quit, among female smokers through training female youth as smoking cessation and reduction ambassadors (SCRA). The objectives are to: 1. Promote age and gender-specific smoking cessation and reduction to the female population 2. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- receiving age and gender-specific SC advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Aug 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- be able to communicate with Cantonese
Who cannot join
- taking Psychiatric drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Smoking Cessation for Female Smokers in Hong Kong Through Training Female Youth Smoking Cessation and Reduction Ambassadors (SCRA)
This project aims to promote quitting, and reduction for those who do not want to quit, among female smokers through training female youth as smoking cessation and reduction ambassadors (SCRA). The objectives are to:
- Promote age and gender-specific smoking cessation and reduction to the female population
- Deliver a smoking cessation and reduction ambassador training workshop to equip and empower female youth with the knowledge on the adverse effects of smoking on female smokers and the skills in smoking cessation and reduction and in raising public awareness of the harmful effects of smoking on female smokers.
- Have the trained female youth to deliver a brief advice (AWARD) to female smokers to help them to quit or reduce smoking and refer them to the female-specific smoking cessation hotline or the Department of Health Quitline for further assistance if needed.
Read the detailed description
Phase I: Increase public awareness of the beneficial effects of smoking cessation on female smokers Five thousand leaflets on woman smoking cessation will be distributed to the Girl Guide, the University of Hong Kong and 40 secondary schools. For those who are not ready to join the training, they will be encouraged to help to increase the awareness of the importance of promoting smoking cessation by disseminating the leaflets to others, especially female smokers in the population.
Phase II: Deliver a smoking cessation training curriculum for the female youth recruited through the Hong Kong Girl Guides Association, the University of Hong Kong and 40 secondary schools.
The investigators aim to train 120-150 female youth (with the priority given to the Hong Kong Girl Guides Association) to be SCRA with better understanding on the needs and feelings of female smokers.The investigators will deliver a half-day SCRA training workshop to the female youth. In addition to the leaflets above, the investigators shall publicize the training workshop and recruit participants via bulk emails, newsletters and the homepage of the Hong Kong Girl Guides Association, the University of Hong Kong and 40 secondary schools. The investigators will draw on our experience in conducting smoking cessation training programmes for our existing projects such as Youth Quitline and Quit to Win Contests. In addition, the investigators shall train and empower participants how to deliver a brief smoking cessation advice to female smokers. For those who do not want to quit, they will be advised to reduce smoking as the first step towards quitting. Throughout the training, participants will be taught to deliver the "AWARD" approach: 1) Ask about smoking, 2) Warn the smokers that at least half will be killed by smoking, and the female specific harms due to smoking, 3) Advise to quit (or reduce) as soon as possible, 4) Refer to a cessation clinic or hotline, and 5) Do it again until they quit.7 At the end of the training workshop, participants should be capable of delivering brief smoking cessation and reduction advice to female smokers, and a referral system will be set up so that women who accept more intensive counselling can be referred to our and other more specialised smoking cessation services. Upon completion of the training, a certificate of attendance will be awarded to the participants.
The outcomes of the training will be evaluated before and immediately afterwards, and 3- and 6-month post training. A smoking-, tobacco control-, and smoking cessation and reduction-related knowledge, attitudes and practice (KAP) survey, 15 using a modified version of previous questionnaires which have been used to assess other smoking cessation training workshop,16 will be conducted.
Additionally, there is increasing evidence that the Health Action Process Approach (HAPA) is helpful in explaining the psychological mechanisms in bridging the gap between intention and actual change in health behaviour.17 According to HAPA model, an individual's intention either to engage in a preventive measure or to modify risky behaviour in favour of a healthy practice, action plans and action control help the individual to structure a strategy for maintaining healthy practices and defeating other conflicting ideas.18 Adopting the HAPA model,17 intention, self-efficacy, and planning to provide smoking cessation and reduction advice will also be assessed.
Phase III: Deliver a age and gender-specific smoking cessation advice
The trained female SCRA will be encouraged to deliver "AWARD" to at least 2 female smokers to advise them to reduce and quit smoking. Self-help smoking cessation booklet designed by Hong Kong Council on Smoking and Health, a partner of our smoking cessation research team, will be provided. The trained youth ambassadors can identify and reach the target female smokers in the following ways:
- from their family members, relatives, friends, peers, schoolmates, or colleagues in workplaces;
- If the trained youth ambassadors cannot identify and reach target female smokers from (1), the investigators can refer female smokers to them through our other smoking cessation projects, such as Youth Quitline or Quit to Win project with the consensus from the female smokers
- Conditions
- Smoking Cessation
- Being tested
- receiving age and gender-specific SC advice
- Keywords
- female
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
receiving age and gender-specific SC adviceOther
After delivering the "AWARD" advice, the trained SCRA will seek consent from and refer adult female smokers (aged over 25 years) to our intensive smoking cessation telephone or face-to-face counselling interventions, which has already counselled 509 female smokers with a quit rate of 29.7% at 6-month and 26.7% at 3-year follow up. Female youth smokers will give consent and be referred to our Youth Quitline (5111 4333), a smoking cessation telephone counselling for young people aged 25 or below which has counselled 1257 smokers with a quit rate of 21.9% at 6 months. If necessary, the female smokers can be referred to other smoking cessation services (e.g., the integrated smoking cessation hotline by the Department of Health (1833-183).
| Study group | Role | What they receive |
|---|---|---|
| receiving age and gender-specific SC advice | Other | After delivering the "AWARD" advice, the trained SCRA will seek consent from and refer adult female smokers (aged over 25 years) to our intensive smoking cessation telephone or face-to-face counselling interventions, which has already counselled 509 female smokers with a quit rate of 29.7% at 6-month and 26.7% at 3-year follow up. Female youth smokers will give consent and be referred to our Youth Quitline (5111 4333), a smoking cessation telephone counselling for young people aged 25 or below which has counselled 1257 smokers with a quit rate of 21.9% at 6 months. If necessary, the female smokers can be referred to other smoking cessation services (e.g., the integrated smoking cessation hotline by the Department of Health (1833-183). Receives: Other: receiving age and gender-specific SC advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
The self-reported quit rate
not smoke for at least 7 days
Measured: 6-month follow-up
Secondary outcomes (4)
biochemical-validated quit rate
measurement of exhaled (CO) and salivary cotinine level
Measured: 6-month follow-up
smoking reduction rate
Measured: 1-, 3-, and 6-month follow-up
smoking quit attempt
Measured: 1-, 3-, and 6-month follow-up
KAP change of SCRA from baseline to 3- and 6-month follow-up
Use questionnaires to measure the change of smoking cessation and reduction-related knowledge, attitudes and practice of Smoking Cessation Ambassadors.
Measured: 3- and 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 posted29 Apr 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2017
- Study completionAug 2017
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- William LI, Phd, Principal investigator, School of Nursing, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755740
- Sponsor's protocol ID
- Girl Guide
- Status last verified
- Oct 2017
- First submitted
- 17 Apr 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Smoking Cessation for Female Smokers in Hong Kong Through Training Female Youth Smoking Cessation and Reduction Ambassadors (SCRA)
- ClinicalTrials.gov ID
- NCT02755740
- Acronym / sponsor ID
- Girl Guide
- Conditions
- Smoking Cessation
- Keywords
- female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- 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 promote quitting, and reduction for those who do not want to quit, among female smokers through training female youth as smoking cessation and reduction ambassadors (SCRA). The objectives are to:
- Promote age and gender-specific smoking cessation and reduction to the female population
- Deliver a smoking cessation and reduction ambassador training workshop to equip and empower female youth with the knowledge on the adverse effects of smoking on female smokers and the skills in smoking cessation and reduction and in raising public awareness of the harmful effects of smoking on female smokers.
- Have the trained female youth to deliver a brief advice (AWARD) to female smokers to help them to quit or reduce smoking and refer them to the female-specific smoking cessation hotline or the Department of Health Quitline for further assistance if needed.
Detailed description
Phase I: Increase public awareness of the beneficial effects of smoking cessation on female smokers Five thousand leaflets on woman smoking cessation will be distributed to the Girl Guide, the University of Hong Kong and 40 secondary schools. For those who are not ready to join the training, they will be encouraged to help to increase the awareness of the importance of promoting smoking cessation by disseminating the leaflets to others, especially female smokers in the population.
Phase II: Deliver a smoking cessation training curriculum for the female youth recruited through the Hong Kong Girl Guides Association, the University of Hong Kong and 40 secondary schools.
The investigators aim to train 120-150 female youth (with the priority given to the Hong Kong Girl Guides Association) to be SCRA with better understanding on the needs and feelings of female smokers.The investigators will deliver a half-day SCRA training workshop to the female youth. In addition to the leaflets above, the investigators shall publicize the training workshop and recruit participants via bulk emails, newsletters and the homepage of the Hong Kong Girl Guides Association, the University of Hong Kong and 40 secondary schools. The investigators will draw on our experience in conducting smoking cessation training programmes for our existing projects such as Youth Quitline and Quit to Win Contests. In addition, the investigators shall train and empower participants how to deliver a brief smoking cessation advice to female smokers. For those who do not want to quit, they will be advised to reduce smoking as the first step towards quitting. Throughout the training, participants will be taught to deliver the "AWARD" approach: 1) Ask about smoking, 2) Warn the smokers that at least half will be killed by smoking, and the female specific harms due to smoking, 3) Advise to quit (or reduce) as soon as possible, 4) Refer to a cessation clinic or hotline, and 5) Do it again until they quit.7 At the end of the training workshop, participants should be capable of delivering brief smoking cessation and reduction advice to female smokers, and a referral system will be set up so that women who accept more intensive counselling can be referred to our and other more specialised smoking cessation services. Upon completion of the training, a certificate of attendance will be awarded to the participants.
The outcomes of the training will be evaluated before and immediately afterwards, and 3- and 6-month post training. A smoking-, tobacco control-, and smoking cessation and reduction-related knowledge, attitudes and practice (KAP) survey, 15 using a modified version of previous questionnaires which have been used to assess other smoking cessation training workshop,16 will be conducted.
Additionally, there is increasing evidence that the Health Action Process Approach (HAPA) is helpful in explaining the psychological mechanisms in bridging the gap between intention and actual change in health behaviour.17 According to HAPA model, an individual's intention either to engage in a preventive measure or to modify risky behaviour in favour of a healthy practice, action plans and action control help the individual to structure a strategy for maintaining healthy practices and defeating other conflicting ideas.18 Adopting the HAPA model,17 intention, self-efficacy, and planning to provide smoking cessation and reduction advice will also be assessed.
Phase III: Deliver a age and gender-specific smoking cessation advice
The trained female SCRA will be encouraged to deliver "AWARD" to at least 2 female smokers to advise them to reduce and quit smoking. Self-help smoking cessation booklet designed by Hong Kong Council on Smoking and Health, a partner of our smoking cessation research team, will be provided. The trained youth ambassadors can identify and reach the target female smokers in the following ways:
- from their family members, relatives, friends, peers, schoolmates, or colleagues in workplaces;
- If the trained youth ambassadors cannot identify and reach target female smokers from (1), the investigators can refer female smokers to them through our other smoking cessation projects, such as Youth Quitline or Quit to Win project with the consensus from the female smokers
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| receiving age and gender-specific SC advice | Other | Other: receiving age and gender-specific SC adviceAfter delivering the "AWARD" advice, the trained SCRA will seek consent from and refer adult female smokers (aged over 25 years) to our intensive smoking cessation telephone or face-to-face counselling interventions, which has already counselled 509 female smokers with a quit rate of 29.7% at 6-month and 26.7% at 3-year follow up. Female youth smokers will give consent and be referred to our Youth Quitline (5111 4333), a smoking cessation telephone counselling for young people aged 25 or below which has counselled 1257 smokers with a quit rate of 21.9% at 6 months. If necessary, the female smokers can be referred to other smoking cessation services (e.g., the integrated smoking cessation hotline by the Department of Health (1833-183). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- be able to communicate with Cantonese
Key exclusion criteria (1 listed)
- taking Psychiatric drugs
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 |
|---|---|---|
| receiving age and gender-specific SC adviceAfter delivering the "AWARD" advice, the trained SCRA will seek consent from and refer adult female smokers (aged over 25 years) to our intensive smoking cessation telephone or face-to-face counselling interventions, which has already counselled 509 female smokers with a quit rate of 29.7% at 6-month and 26.7% at 3-year follow up. Female youth smokers will give consent and be referred to our Youth Quitline (5111 4333), a smoking cessation telephone counselling for young people aged 25 or below which has counselled 1257 smokers with a quit rate of 21.9% at 6 months. If necessary, the female smokers can be referred to other smoking cessation services (e.g., the integrated smoking cessation hotline by the Department of Health (1833-183). | Other | receiving age and gender-specific SC advice |
Primary outcome
The self-reported quit rate
Time frame: 6-month follow-up
not smoke for at least 7 days
4 secondary outcomes
biochemical-validated quit rate
Time frame: 6-month follow-up
smoking reduction rate
Time frame: 1-, 3-, and 6-month follow-up
smoking quit attempt
Time frame: 1-, 3-, and 6-month follow-up
KAP change of SCRA from baseline to 3- and 6-month follow-up
Time frame: 3- and 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 26 Oct 2017.
- 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.
William LI, Phd principal investigator
School of Nursing, 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 receiving age and gender-specific SC advice in people with 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 1 inclusion and 1 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 26 Oct 2017. 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?
The self-reported quit rate (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 26 Oct 2017.