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Promoting Women's Health: A Gender Specific Smoking Cessation Program for Female Smokers in Hong Kong

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717662
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. LI William Ho Cheung, The University of Hong Kong

Brief 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. 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.
  2. 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.
  3. 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.
  4. Develop and evaluate a gender-specific smoking cessation program to help female smokers to reduce and quit smoking.
  5. Promote women's health and quality of life, and reduce the life-long morbidity and mortality of female smokers in the long term.
  6. Examine the long term (3-year) impact of a gender-specific smoking cessation program on the smoking behaviors of female smokers.
  7. Examine another long-term (6-year) impact of a gender-specific smoking cessation program on the smoking behaviors of female smokers.
  8. Ascertain the contributing factors in the rate of quitting, retention and relapse.
  9. Investigate Hong Kong women smokers awareness and attitude to women quitline.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: nicotine gum or nicotine patch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Promoting Women's Health: A Gender Specific Smoking Cessation Program for Female Smokers in Hong Kong
Actual Study Start Date : April 1, 2006
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : November 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brief counseling and NRT
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.
Drug: nicotine gum or nicotine patch
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Bio-chemical validated smoking abstinence at 6-,36-,72-month [ Time Frame: 6-,36-,72-month follow-up ]
    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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only female smokers will be selected.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hong Kong female resident aged 18 or above
  • Able to communicate in Chinese (Cantonese)
  • Current Smokers

Exclusion Criteria:

  • Have difficulty to communicate via telephone
  • Having queries irrelevant to tobacco control

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717662


Contacts
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Contact: Ho-Cheung Li, PhD 39176634 william3@hku.hk

Locations
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China
The University of Hong Kong Recruiting
Hong Kong, China
Contact: Ho Cheung William Ho, PhD    852-39176634    william3@hku.hk   
Principal Investigator: Ho Cheung William Li, PhD         
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Ho-Cheung Li, PhD The University of Hong Kong

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Responsible Party: Dr. LI William Ho Cheung, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03717662    
Other Study ID Numbers: UW 06-323
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. LI William Ho Cheung, The University of Hong Kong:
women
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action