Smoking CessationNCT03717662
Promoting Women's Health: A Gender Specific Smoking Cessation Program for Female Smokers in Hong Kong
A study testing nicotine gum or nicotine patch in people with Smoking Cessation, run by The University of Hong Kong at 1 site in China.
Trial summary
This project aims to publicize quitting among female smokers, and encourage and support those who want to quit by providing face-to-face and/or telephone counseling. The objectives are to: 1. 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?
- nicotine gum or nicotine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2006to 30 Nov 2024
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Ho Cheung William Ho, PhD, 852-39176634, william3@hku.hk
Ho Cheung William Li, PhD
About this study
This project aims to publicize quitting among female smokers, and encourage and support those who want to quit by providing face-to-face and/or telephone counseling. The objectives are to:
- Build up a Women Against Tobacco Taskforce (WATT) with woman volunteers from various organizations to promote quitting in female smokers, and to arouse public awareness of the effects of smoking on sexual, reproductive and child health, and other diseases among women.
- Conduct a survey among the women volunteers and staff of the women's organization to ascertain their learning needs, knowledge, attitudes, and practice of tobacco control and smoking cessation, and to identify interested participants to join the smoking cessation training program.
- Design and deliver a smoking cessation counseling training program (based on the learning needs identified), to equip women volunteers with the knowledge and skills in smoking cessation.
- Develop and evaluate a gender-specific smoking cessation program to help female smokers to reduce and quit smoking.
- Promote women's health and quality of life, and reduce the life-long morbidity and mortality of female smokers in the long term.
- Examine the long term (3-year) impact of a gender-specific smoking cessation program on the smoking behaviors of female smokers.
- Examine another long-term (6-year) impact of a gender-specific smoking cessation program on the smoking behaviors of female smokers.
- Ascertain the contributing factors in the rate of quitting, retention and relapse.
- Investigate Hong Kong women smokers awareness and attitude to women quitline.
Read the detailed description
Phase I: Build up a network and need assessment
- We will invite collaboration with the Hong Kong Women Development Association (18 organizational members and over 30,000 individual members), the Hong Kong Federation of Women (45 organizational members), Women's Club of Family Planning Association (7 Women's Club), Hone Kong Young Women's Christian Association (around 260,000 members) and other woman organizations to build up a network by setting up a Women Against Tobacco Taskforce (WATT) jointly with representatives from women organizations and led by the Department of Nursing Studies of The University of Hong Kong. This proposed Task Force will focus on promoting smoking cessation among female smokers and arousing the public's awareness of health risks specific to women from smoking.
- Need assessment survey and focus group interview of the women volunteers and staff: all volunteers and staff will be invited to participate in a need assessment survey and focus group interview. The perceived needs identified will be used to design a tailor-made smoking cessation counselor training curriculum for the participants, and they will be asked to indicate their interest and commitment to undertake such training (free of charge), and to help women quit smoking.
Phase II:
Design and deliver training curriculum: Based on the needs assessment data, we will design and deliver a tailor-made smoking cessation counseling training program for the woman volunteers and staff. A maximum capacity of 200 participants can be trained. At the end of the program, participants should be capable of delivering smoking cessation advice for women, and a referral system can be set up so that women that required more intensive counseling can be referred to us if necessary. The outcome of the training will be evaluated through a survey before and immediate after, and 6 months post training, which include: knowledge, attitudes, and practice of smoking cessation.
We aim to train women smoking cessation counselors as they can better understand the needs and feelings of female smokers. Female addiction to cigarette smoking may be reinforced more by the sensory and social context of smoking2, and therefore it is important to reduce the gap between the female smoker and the counselor. Upon completion of the program, a certificate of attendance will be awarded to the participants and their organizations for their contribution.
Phase III:
- Brief gender-specific advice provided by trained women volunteers: The trained women counselors will use motivational approach to provide smoking cessation advice to female smokers.
- Intensive gender-specific intervention provided by experience nurse counselor: The project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers (including all types of tobacco products such as shisha, electronic cigarettes and heat-not-burn (HNB) which are available in the market) who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention. Their smoking status, information about usage of nicotine replacement products and quality of life measures will be assessed. All women reported to have quit smoking at 6-, 36- and 72-month will be invited for biochemical validation (measurement of urine / saliva cotinine level). Participants will be invited to do qualitative interviews (individual / focus group interviews) at the 36-month follow up. Interviews will be conducted according to participants' smoking status (3 levels: continuous smoker; those who had quit attempts but relapsed; and those who abstained from tobacco within the 3-year period) and martial status (2 levels: single; and married). 30 participants with 5 subjects per group will be recruited. Each interview will last for 60 minutes and to be conducted by an experienced facilitator at the School of Nursing, The University of Hong Kong. During each individual interview, the facilitator will first welcome the participants, obtain written consent, and assure that the interview will be audio-taped and kept confidential. The facilitator will guide the discussion using an interview guide and prompt for further information as necessary.
Phase IV:
The trained women counsellors will observe the women smokers on the street and walk forward to look for opportunities talking to them. Counsellors will first explain the basic information of this research and acquire their reliance. After we got the permission to conduct a small interview, smokers will be asked a few questions about their awareness about women quitline and obstruction to call the quitline. Each interview will last no more than 10 minutes. We can invite them to participate in a further phone call survey and encourage them to leave their phone number.
- Conditions
- Smoking Cessation
- Being tested
- nicotine gum or nicotine patch
- 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.
nicotine gum or nicotine patchDrug
The project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention.
| Study group | Role | What they receive |
|---|---|---|
| Brief counseling and NRT | Experimental | The project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers (including all types of tobacco products such as shisha, electronic cigarettes and heat-not-burn (HNB) which are available in the market) who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention. Receives: Drug: nicotine gum or nicotine patch |
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
the reduced cigarette consumption; progression to a higher stage of readiness to change; quit attempts, and increased self-efficacy to quitting smoking. In the long term, the quit rate (not smoke for at least 7 days during the time of follow up); smoking reduction, progression of stage of readiness, at 6 months; and change in quality of life
Measured: 6-month follow-up
Secondary outcomes (1)
Bio-chemical validated smoking abstinence at 6-,36-,72-month
Bio-chemical validated smoking abstinence is measured at 6-,36-,72-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-,36-,72-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 start1 Apr 2006
- Primary completion1 Oct 2024 (estimated)
- Study completion30 Nov 2024 (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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
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
- NCT03717662
- Sponsor's protocol ID
- UW 06-323
- Status last verified
- Dec 2020
- First submitted
- 22 Oct 2018
- Last updated
- 21 Dec 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 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Women's Health: A Gender Specific Smoking Cessation Program for Female Smokers in Hong Kong
- ClinicalTrials.gov ID
- NCT03717662
- Acronym / sponsor ID
- UW 06-323
- Conditions
- Smoking Cessation
- Keywords
- women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- 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 publicize quitting among female smokers, and encourage and support those who want to quit by providing face-to-face and/or telephone counseling. The objectives are to:
- Build up a Women Against Tobacco Taskforce (WATT) with woman volunteers from various organizations to promote quitting in female smokers, and to arouse public awareness of the effects of smoking on sexual, reproductive and child health, and other diseases among women.
- Conduct a survey among the women volunteers and staff of the women's organization to ascertain their learning needs, knowledge, attitudes, and practice of tobacco control and smoking cessation, and to identify interested participants to join the smoking cessation training program.
- Design and deliver a smoking cessation counseling training program (based on the learning needs identified), to equip women volunteers with the knowledge and skills in smoking cessation.
- Develop and evaluate a gender-specific smoking cessation program to help female smokers to reduce and quit smoking.
- Promote women's health and quality of life, and reduce the life-long morbidity and mortality of female smokers in the long term.
- Examine the long term (3-year) impact of a gender-specific smoking cessation program on the smoking behaviors of female smokers.
- Examine another long-term (6-year) impact of a gender-specific smoking cessation program on the smoking behaviors of female smokers.
- Ascertain the contributing factors in the rate of quitting, retention and relapse.
- Investigate Hong Kong women smokers awareness and attitude to women quitline.
Detailed description
Phase I: Build up a network and need assessment
- We will invite collaboration with the Hong Kong Women Development Association (18 organizational members and over 30,000 individual members), the Hong Kong Federation of Women (45 organizational members), Women's Club of Family Planning Association (7 Women's Club), Hone Kong Young Women's Christian Association (around 260,000 members) and other woman organizations to build up a network by setting up a Women Against Tobacco Taskforce (WATT) jointly with representatives from women organizations and led by the Department of Nursing Studies of The University of Hong Kong. This proposed Task Force will focus on promoting smoking cessation among female smokers and arousing the public's awareness of health risks specific to women from smoking.
- Need assessment survey and focus group interview of the women volunteers and staff: all volunteers and staff will be invited to participate in a need assessment survey and focus group interview. The perceived needs identified will be used to design a tailor-made smoking cessation counselor training curriculum for the participants, and they will be asked to indicate their interest and commitment to undertake such training (free of charge), and to help women quit smoking.
Phase II:
Design and deliver training curriculum: Based on the needs assessment data, we will design and deliver a tailor-made smoking cessation counseling training program for the woman volunteers and staff. A maximum capacity of 200 participants can be trained. At the end of the program, participants should be capable of delivering smoking cessation advice for women, and a referral system can be set up so that women that required more intensive counseling can be referred to us if necessary. The outcome of the training will be evaluated through a survey before and immediate after, and 6 months post training, which include: knowledge, attitudes, and practice of smoking cessation.
We aim to train women smoking cessation counselors as they can better understand the needs and feelings of female smokers. Female addiction to cigarette smoking may be reinforced more by the sensory and social context of smoking2, and therefore it is important to reduce the gap between the female smoker and the counselor. Upon completion of the program, a certificate of attendance will be awarded to the participants and their organizations for their contribution.
Phase III:
- Brief gender-specific advice provided by trained women volunteers: The trained women counselors will use motivational approach to provide smoking cessation advice to female smokers.
- Intensive gender-specific intervention provided by experience nurse counselor: The project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers (including all types of tobacco products such as shisha, electronic cigarettes and heat-not-burn (HNB) which are available in the market) who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention. Their smoking status, information about usage of nicotine replacement products and quality of life measures will be assessed. All women reported to have quit smoking at 6-, 36- and 72-month will be invited for biochemical validation (measurement of urine / saliva cotinine level). Participants will be invited to do qualitative interviews (individual / focus group interviews) at the 36-month follow up. Interviews will be conducted according to participants' smoking status (3 levels: continuous smoker; those who had quit attempts but relapsed; and those who abstained from tobacco within the 3-year period) and martial status (2 levels: single; and married). 30 participants with 5 subjects per group will be recruited. Each interview will last for 60 minutes and to be conducted by an experienced facilitator at the School of Nursing, The University of Hong Kong. During each individual interview, the facilitator will first welcome the participants, obtain written consent, and assure that the interview will be audio-taped and kept confidential. The facilitator will guide the discussion using an interview guide and prompt for further information as necessary.
Phase IV:
The trained women counsellors will observe the women smokers on the street and walk forward to look for opportunities talking to them. Counsellors will first explain the basic information of this research and acquire their reliance. After we got the permission to conduct a small interview, smokers will be asked a few questions about their awareness about women quitline and obstruction to call the quitline. Each interview will last no more than 10 minutes. We can invite them to participate in a further phone call survey and encourage them to leave their phone number.
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 |
|---|---|---|
| Brief counseling and NRT | Experimental | Drug: nicotine gum or nicotine patchThe project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers (including all types of tobacco products such as shisha, electronic cigarettes and heat-not-burn (HNB) which are available in the market) who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| nicotine gum or nicotine patchThe project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention. | Drug | Brief counseling and NRT |
Primary outcome
7-days point prevalence smoking abstinence at 6-month
Time frame: 6-month follow-up
the reduced cigarette consumption; progression to a higher stage of readiness to change; quit attempts, and increased self-efficacy to quitting smoking. In the long term, the quit rate (not smoke for at least 7 days during the time of follow up); smoking reduction, progression of stage of readiness, at 6 months; and change in quality of life
1 secondary outcome
Bio-chemical validated smoking abstinence at 6-,36-,72-month
Time frame: 6-,36-,72-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 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?
A study testing nicotine gum or nicotine patch 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 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: status not confirmed, as of the sponsor's last update on 21 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho-Cheung Li, PhD (39176634, william3@hku.hk), or a site near the patient. 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 21 Dec 2020.