- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02659774
Smoking Cessation in Workplaces in Hong Kong [Phase II]
Assessing the Corporate Environment in Promoting Tobacco Control and Evaluation of a Smoking Cessation Programme in Workplaces in Hong Kong
This study has the following objectives:
- To examine the employers'/managerial staff's knowledge, attitudes and practices in promoting smoking cessation in workplace.
- To evaluate the smoking behaviours of participants before and after attending a smoking cessation intervention.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Study design In Phase I of this study, a large scale cross-sectional survey will be sent to 3000 corporations in Hong Kong. The questionnaire will examine the employers' knowledge, attitudes and practices in promoting smoking cessation in the workplace.
In Phase II, a longitudinal study will be conducted to evaluate the effectiveness of a smoking cessation intervention offered by the Department of Psychology, the University of Hong Kong. A total of 600 smokers from corporations will be recruited and interviewed before the intervention at baseline, immediately after the intervention, and at 1-, 4-, 12-, 26- and 52-week post-intervention follow-ups, in an attempt to evaluate their smoking behaviours, knowledge on smoking and satisfaction of the smoking cessation services. Self-reported quitters (did not smoke in the past 7 days) will be invited to participate in the bio-chemical validation by assessing their exhaled carbon monoxide level and the saliva cotinine level.
Process evaluation: Qualitative interviews, including in-depth interviews and/or focus group will be conducted within 1 month after 12-month follow-up.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Hong Kong, China
- 2/F, 61 Lung Kong Rd, Kowloon City, Lok Sin Tong Benevolent Society
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Hong Kong residents aged 18 or above
- Cantonese speaker and able to read in Chinese characters
- Smoke at least one cigarette per day
- Stay at Hong Kong during the intervention and follow-up periods (12 months)
Exclusion Criteria:
- Smokers who are psychologically or physically unable to communicate
- Smokers who are currently following other smoking cessation programme(s)
- Smokers with diagnosed psychiatric illnesses
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group A
Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)
|
Through intensive workshop which includes motivation of quitting enhancement, stress management, smoking triggers, cravings and relapse, to provide smoking cessation intervention
Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking
Use motivational interview strategies through telephone messages to provide smoking cessation intervention
A 26-page booklet included information about smoking and diseases, benefits of quitting smoking, methods to quit smoking, how to handle withdrawal symptoms, stress management, declaration of quitting smoking, decisional balance of smoking or quitting
|
|
Placebo-vergelijker: Group B
Face to Face counseling (Motivational intervention) + Booklet + SMS
|
Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking
Use motivational interview strategies through telephone messages to provide smoking cessation intervention
A 26-page booklet included information about smoking and diseases, benefits of quitting smoking, methods to quit smoking, how to handle withdrawal symptoms, stress management, declaration of quitting smoking, decisional balance of smoking or quitting
Use motivational interview strategies through face-to-face counseling to provide smoking cessation intervention
|
|
Placebo-vergelijker: Group C
Phone counseling (Motivational intervention) + Health talk + booklet + SMS
|
Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking
Use motivational interview strategies through telephone messages to provide smoking cessation intervention
A 26-page booklet included information about smoking and diseases, benefits of quitting smoking, methods to quit smoking, how to handle withdrawal symptoms, stress management, declaration of quitting smoking, decisional balance of smoking or quitting
|
|
Placebo-vergelijker: Group D
Phone counseling (Motivational intervention) + booklet + SMS
|
Use motivational interview strategies through telephone messages to provide smoking cessation intervention
A 26-page booklet included information about smoking and diseases, benefits of quitting smoking, methods to quit smoking, how to handle withdrawal symptoms, stress management, declaration of quitting smoking, decisional balance of smoking or quitting
Use motivational interview strategies through telephone counseling to provide smoking cessation intervention
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline smoking quit rate at 6-month
Tijdsspanne: 6 months after the intervention
|
Quit smoking rate is defined by the self-reported 7-day point prevalence abstinence.
It is a binary type (yes/no) questionnaire and participants answer the question about their smoking status in the past 7 days at 6-month after the intervention.
|
6 months after the intervention
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline smoking reduction at 6-month
Tijdsspanne: 6 months after the intervention
|
Smoking reduction is defined as reduced at least 50% of cigarette consumption.
Participants were asked to respond to the daily cigarette consumption at 6-month after the intervention.
Their daily cigarette consumption at 6-month were compared with baseline's daily cigarette consumption and determine whether they had reduced at least 50% cigarette consumption at 6-month.
|
6 months after the intervention
|
|
Change from baseline smoking reduction at 12-month
Tijdsspanne: 12 months after the intervention
|
Smoking reduction is defined as reduced at least 50% of cigarette consumption.
Participants were asked to respond to the daily cigarette consumption at 6-month after the intervention.
Their daily cigarette consumption at 12-month were compared with baseline's daily cigarette consumption and determine whether they had reduced at least 50% cigarette consumption at 12-month.
|
12 months after the intervention
|
|
Change from baseline smoking quit rate at 12-month
Tijdsspanne: 12 months after the intervention
|
Quit smoking rate is defined by the self-reported 7-day point prevalence abstinence.
It is a binary type (yes/no) questionnaire and participants answer the question about their smoking status in the past 7 days at 12-month after the intervention.
|
12 months after the intervention
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Man-ping Wang, PhD, School of Nursing, The University of Hong Kong
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- LSTWPLACE2015
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .