NCT03717662

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
12.6 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

18.5 years

First QC Date

October 22, 2018

Last Update Submit

December 17, 2020

Conditions

Keywords

women

Outcome Measures

Primary Outcomes (1)

  • 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

    6-month follow-up

Secondary Outcomes (1)

  • Bio-chemical validated smoking abstinence at 6-,36-,72-month

    6-,36-,72-month follow-up

Study Arms (1)

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.

Drug: nicotine gum or nicotine patch

Interventions

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.

Brief counseling and NRT

Eligibility Criteria

Age15 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female smokers will be selected.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Chewing GumTobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Chewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ho-Cheung Li, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho-Cheung Li, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

April 1, 2006

Primary Completion

October 1, 2024

Study Completion

November 30, 2024

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations