Smoking Cessation Programme in Workplaces in Hong Kong (Phase ⅤII)

Официальное название

Evaluation of a Smoking Cessation Program in Workplaces in Hong Kong: a Pragmatic Randomized Controlled Trial on Mobile Phone-Based Intervention Combined With Small Incentive for Smoking Cessation

Обзор

Smoking cessation (SC) interventions using behavioral economics mainly focus on financial incentives, which were used to change health behaviors by utilizing a reward system to enhance long-term maintenance. Incentives have been demonstrated to enhance SC across various populations with moderate effects. Interventions for smoking cessation characterized by financial incentives focus primarily on the potential for monetary gain rather than loss. Changing the motivational strategy to combine disclosing losses with providing financial incentives may increase the effectiveness of financial consequence-based smoking cessation interventions. Thus, this study aims to test, by a 2-arm RCT, the effectiveness of an intervention of which includes mobile phone-based intervention combined with small incentive and smoking cessation in workplaces in Hong Kong; identify facilitators and barriers of successful policy implementation and quitting; examine and evaluate the company environment and their policies in promoting smoking cessation.

Подробное описание

This study will separate into two phases. Phase I is a large scale cross-sectional survey of corporations in Hong Kong to examine the employers' knowledge, attitudes and practices in promoting SC in the workplace. Phase II is a 2-arm randomized controlled trial that will be conducted to examine the effectiveness of mobile phone-based intervention combined with company health talk, brief phone counselling and nicotine replacement therapy sampling, for SC in workplaces.

Data analyses Phase I: Descriptive statistics will be used to analyze the (1) profile of the corporations, including the total number of employees and smoking employees; (2) employers/managerial staff's knowledge on smoking; (3) employers/managerial staff's attitudes on smoking cessation; (4) practices of the companies with respect to smoking cessation.

Phase II: Primary outcome is self-reported abstinence in the past 7 days at 6-month follow-up. Secondary outcomes for smoking cessation include self-reported abstinence in the past 7 days at 9- and 12-month follow-ups, the biochemically validated abstinence (defined as exhaled CO level \<4ppm and saliva cotinine level ≤30 ng/ml); smoking reduction (50% or above reduction in cigarette consumption compared with baseline. Secondary outcomes for mental health include stress (Perceived Stress Scale-10), depression (Personal Health Questionnaire for Depression), anxiety (Generalized Anxiety Disorder scale) and self-rated health.

Descriptive statistics such as frequency, percentage, and mean will be used to summarize the outcomes and other variables. Chi-square tests and t-tests will be used to compare outcome variables between subgroups. The intention-to-treat (ITT) analysis will be used such that those lost to contact and refused cases at the follow-ups will be treated as no reduction in cigarette consumption nor quitting. Multiple imputations will be used to compute missing data for outcome variables. The association between intervention adherence (e.g., engagement in the IM interaction) and the primary outcome within the participants in the intervention group will be examined. The intervention effect by subgroups will be assessed respectively, including sex, age, education level, company types, previous quit attempts, cigarette dependence, and intention to quit, although the statistical power would be lower due to smaller numbers.

Вмешательства

• Поведенческое General health talk
  Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.
• Поведенческое Personalized chat-based interactions
  Individual chat-based interactions for 3 months consist of 2 parts. The first part includes regular messages via instant messages (IM). These messages will serve as probes for real-time chat-based support in which more details explanations and motivation to encourage quitting due to financial reasons. The second part includes real-time psycho-behavioral intervention delivered by trained cessation counsellors using health economic principles on behavioral change to motivate smokers to quit. The c
• Поведенческое Phone follow-up/counselling service
  The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
• Препарат Mailed nicotine replacement therapy (NRT)
  Full course of NRT treatment (10 weeks) will be provided to all participants who are still smoking at 6-month follow-up and request, or willing to use NRT after advice from counsellors. Medications will be mailed from the smoking cessation clinics.
• Поведенческое Text message
  Regular messages will be sent twice per month within 3 months. These messages covers simple cessation advice and reminders for follow-ups.
• Другое Small incentive
  Positive incentive was reported to be effective in reducing smoking. Participants in the intervention group will receive HK$ 100 at 3-month follow-up. HK$ 500 will be provided to successful quitters confirmed by biochemical validation at 6 months. A total of HK$ 600 maximum will be rewarded to the participants. The amount of the incentive is comparable to other community events on smoking cessation in Hong Kong. Of note, all smokers who reported quitting, completed and passed the biochemical val

Первичные конечные точки

• Biochemical validation of smoking status [Срок оценки: 6-month]

Вторичные конечные точки (4)

• Self-reported 7-day point prevalence quit rate [Срок оценки: 1-, 3- and 12-month]
• Biochemical validation of smoking status [Срок оценки: 12-month]
• Self-reported reduction cigarette rate [Срок оценки: 1-, 3-, 6- and 12-month]
• Self-reported use of nicotine replacement therapy (NRT) [Срок оценки: 1-, 3-, 6- and 12-month]

Критерии участия

Критерии включения

• Hong Kong residents aged 18 or above
• Current smoking cigarettes or alternative tobacco products daily with an exhaled carbon monoxide level ≥4 ppm or a positive salivary cotinine test
• Able to communicate in Cantonese/Mandarin and read Chinese
• Able to use instant messaging tool (e.g. WhatsApp) for communication.
• Stay in Hong Kong during the intervention and follow-up periods (12 months)

Критерии исключения

• Smokers who are psychologically or physically unable to communicate
• Currently following other SC program(s)
• Having used NRT for the past month
• Having severe angina, serious cardiac arrhythmias and hypertension
• Have acute myocardial event in the past month
• Being pregnant or providing breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Гонконг · 1 центр

• School of Nursing, The University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT06932718 · LST SCPW P7

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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