- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Hong Kong, China
- 2/F, 61 Lung Kong Rd, Kowloon City, Lok Sin Tong Benevolent Society
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Group A
Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)
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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
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Comparador de Placebo: Group B
Face to Face counseling (Motivational intervention) + Booklet + SMS
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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
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Comparador de Placebo: 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
|
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Comparador de Placebo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline smoking quit rate at 6-month
Prazo: 6 months after the intervention
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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.
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6 months after the intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline smoking reduction at 6-month
Prazo: 6 months after the intervention
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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.
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6 months after the intervention
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Change from baseline smoking reduction at 12-month
Prazo: 12 months after the intervention
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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.
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12 months after the intervention
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Change from baseline smoking quit rate at 12-month
Prazo: 12 months after the intervention
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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.
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12 months after the intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Man-ping Wang, PhD, School of Nursing, The University of Hong Kong
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- LSTWPLACE2015
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