- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Hong Kong, Porcelana
- 2/F, 61 Lung Kong Rd, Kowloon City, Lok Sin Tong Benevolent Society
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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
|
Comparador de placebos: 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
|
Comparador de placebos: 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
|
Comparador de placebos: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline smoking quit rate at 6-month
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline smoking reduction at 6-month
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Man-ping Wang, PhD, School of Nursing, The University of Hong Kong
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- LSTWPLACE2015
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre workshop (Motivational intervention)
-
University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
-
Shiraz University of Medical SciencesTerminado
-
Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
-
Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
-
Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de oposición desafiante | Trastorno de conductaCanadá
-
The Hospital for Sick ChildrenTerminadoObesidad infantilCanadá
-
VA Office of Research and DevelopmentTerminadoTrastornos de Estrés PostraumáticoEstados Unidos
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... y otros colaboradoresActivo, no reclutandoTrastornos del neurodesarrollo | Trastornos del ComportamientoCanadá
-
Sahlgrenska University Hospital, SwedenKarolinska University Hospital; Skane University Hospital; Karlstad Central Hospital y otros colaboradoresActivo, no reclutandoClaudicación intermitenteSuecia