An Integrated Smoking Cessation Intervention Model of Brief Advice, Nicotine Replacement Therapy and Mobile Health Support for Smoking Parents to Increase Abstinence and Protect Children From Tobacco Smoke Exposure: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Biochemically validated abstinence
研究概览
简要总结
This project aims to test the effectiveness of an integrated intervention of brief cessation advice (AWARD), Nicotine Replacement Therapy, and Instant Messaging support compared with waitlist control participants among adult daily smokers who lived with their children and non-smoking partners.
详细描述
Background: Around 40% of children worldwide were exposed to secondhand smoke (SHS). Despite reaching a single-digit smoking prevalence of 9.5% in 2022, about one in three children in Hong Kong (36.2%) are still exposed to SHS, mostly at home. Especially children from deprived households, suffer from a higher risk of more pervasive SHS exposure. Aim: The project aims to apply evidence-based interventions to increase smoking cessation and reduce SHS exposure in children of disadvantaged families. The specific objectives of the study are (1) to evaluate the effectiveness of a novel, family-based intervention model in increasing smoking cessation and reducing SHS exposure in children of disadvantaged families, (2) to alert parents in recognizing their child's exposure level and take actions in protecting their child from exposure, (3) to advocate for the adoption of this resource-efficient intervention model in Non-Governmental Organizations(NGOs), District Health Centre Express(DHC/Es), and other smoking cessation service providers in Hong Kong.
Methods: A family-based smoking cessation that collect comprehensive biochemical and environmental data of SHS exposure, and apply evidence-based interventions to prevent the SHS exposure and support quitting in deprived households. Two domains of outcome will be assessed: (1) Effectiveness and overall impact of smoking cessation intervention. (2) Cost-effectiveness analysis and qualitative interviews to estimate the scalability and mechanisms of interventions.
Procedure: Participants will be actively recruited through different channels including direct referral from Non-Governmental Organizations (NGOs) with social housing schemes, referral and recruitment from District Health Centre (DHC), community-based recruitment activities in smoking hotspots, and online advertisement on search engines and social media sites. The eligibility of smokers and non-smokers will be assessed by counselors and invited to join the randomized controlled trial and allocated to one of the groups of the smoking cessation intervention. 6 follow ups at 1 week, 1,2,3,6,12 months will be conducted to both smokers and non-smokers to reveal their SHS exposure level and smoker's quitting progress.
Hypothesis
We hypothesize that the assessment-guided intervention will lead to significant increases in rates of smoking cessation in the intervention group than the control group. Another hypothesis to be investigated is that designated intervention messages are effective to reduce the level of SHS participants and their family members exposed to.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hong Kong residents aged 18 or above
- •Smoke at least 1 tobacco stick (includes HTP) per day or use e-cigarette daily in the preceding 3-month and verified by exhaled carbon monoxide level of 4ppm (parts per million) or above, assessed by a validated Carbon monoxide Smokerlyzer®
- •Living with at least one child of primary 6 or below (aged 12 or below)
- •Living with at least one non-smoking family member
- •Living in deprived households (monthly household income of less than the median of household monthly income in Hong Kong, HK$ 28,000, or living in subdivided flats or social housing)
- •Able to communicate in Chinese (including reading Chinese in IM)
- •Able to use the instant messaging tool (e.g., WhatsApp, WeChat) for communication
排除标准
- •Those who have communication barriers (either physically or cognitively)
- •Those who are currently participating in other smoking cessation programmes or services
研究组 & 干预措施
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives
Participants will receive a special designed evidence-based intervention using health advice, behavioral and pharmacological support, mobile health technologies, and awareness building (highlight harms) based on the biofeedback results of SHS exposure in the child. A selected sample of 50 families will receive environmental assessment-derived intervention, including results interpretation and health advice, which will be provided via phone calls for the 50 families within 1 week after the data collection.
干预措施: Financial Incentive (FI) (Behavioral)
Brief cessation advice (AWARD) + Waitlist for same intervention
Participants in the control group will receive the same AWARD brief advice model, self-help booklet at baseline, and financial incentives for validated abstinence at 3- and 6-month follow-up. After the 6-month follow-up, participants who continued to smoke will receive the remaining intervention components: 1-week sampling of NRT and 3 months instant messaging chat-based personalized psychosocial and behavioural counselling for quitting. Participants who validated abstinence at the 12 months or actively engaged in mobile Health counselling will also receive the financial incentives of HK$ 500 and HK$ 200, respectively (waitlist control).
Similar to the Intervention group, environmental assessment derived intervention, including results interpretation and health advice, will be provided via phone calls for the 50 families within 1 week after the data collection.
干预措施: Brief cessation advice (AWARD) (Behavioral)
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives
Participants will receive a special designed evidence-based intervention using health advice, behavioral and pharmacological support, mobile health technologies, and awareness building (highlight harms) based on the biofeedback results of SHS exposure in the child. A selected sample of 50 families will receive environmental assessment-derived intervention, including results interpretation and health advice, which will be provided via phone calls for the 50 families within 1 week after the data collection.
干预措施: Environmental assessment derived intervention (Behavioral)
Brief cessation advice (AWARD) + Waitlist for same intervention
Participants in the control group will receive the same AWARD brief advice model, self-help booklet at baseline, and financial incentives for validated abstinence at 3- and 6-month follow-up. After the 6-month follow-up, participants who continued to smoke will receive the remaining intervention components: 1-week sampling of NRT and 3 months instant messaging chat-based personalized psychosocial and behavioural counselling for quitting. Participants who validated abstinence at the 12 months or actively engaged in mobile Health counselling will also receive the financial incentives of HK$ 500 and HK$ 200, respectively (waitlist control).
Similar to the Intervention group, environmental assessment derived intervention, including results interpretation and health advice, will be provided via phone calls for the 50 families within 1 week after the data collection.
干预措施: Self-help smoking cessation booklet (Behavioral)
Brief cessation advice (AWARD) + Waitlist for same intervention
Participants in the control group will receive the same AWARD brief advice model, self-help booklet at baseline, and financial incentives for validated abstinence at 3- and 6-month follow-up. After the 6-month follow-up, participants who continued to smoke will receive the remaining intervention components: 1-week sampling of NRT and 3 months instant messaging chat-based personalized psychosocial and behavioural counselling for quitting. Participants who validated abstinence at the 12 months or actively engaged in mobile Health counselling will also receive the financial incentives of HK$ 500 and HK$ 200, respectively (waitlist control).
Similar to the Intervention group, environmental assessment derived intervention, including results interpretation and health advice, will be provided via phone calls for the 50 families within 1 week after the data collection.
干预措施: Environmental assessment derived intervention (Behavioral)
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives
Participants will receive a special designed evidence-based intervention using health advice, behavioral and pharmacological support, mobile health technologies, and awareness building (highlight harms) based on the biofeedback results of SHS exposure in the child. A selected sample of 50 families will receive environmental assessment-derived intervention, including results interpretation and health advice, which will be provided via phone calls for the 50 families within 1 week after the data collection.
干预措施: Brief cessation advice (AWARD) (Behavioral)
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives
Participants will receive a special designed evidence-based intervention using health advice, behavioral and pharmacological support, mobile health technologies, and awareness building (highlight harms) based on the biofeedback results of SHS exposure in the child. A selected sample of 50 families will receive environmental assessment-derived intervention, including results interpretation and health advice, which will be provided via phone calls for the 50 families within 1 week after the data collection.
干预措施: Self-help smoking cessation booklet (Behavioral)
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives
Participants will receive a special designed evidence-based intervention using health advice, behavioral and pharmacological support, mobile health technologies, and awareness building (highlight harms) based on the biofeedback results of SHS exposure in the child. A selected sample of 50 families will receive environmental assessment-derived intervention, including results interpretation and health advice, which will be provided via phone calls for the 50 families within 1 week after the data collection.
干预措施: Instant messaging Support (IM) (Behavioral)
Brief cessation advice + Nicotine replacement Therapy + Instant Messaging + Financial Incentives
Participants will receive a special designed evidence-based intervention using health advice, behavioral and pharmacological support, mobile health technologies, and awareness building (highlight harms) based on the biofeedback results of SHS exposure in the child. A selected sample of 50 families will receive environmental assessment-derived intervention, including results interpretation and health advice, which will be provided via phone calls for the 50 families within 1 week after the data collection.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
结局指标
主要结局
Biochemically validated abstinence
时间窗: 6-month after recruitment
Defined as exhaled carbon monoxide level \<4ppm and saliva cotinine level ≤30ng/ml
次要结局
- Self-reported 7-day point prevalence quit rate (for smokers)(3- and 6-month after recruitment)
- Self-reported reduction rate (for smokers)(3- and 6-month after recruitment)
- Self-rated health (for smokers)(3- and 6-month after recruitment)
- Respiratory symptoms (for smokers, family member and children)(3- and 6-month after recruitment)
- Self-reported secondhand smoke exposure (for children and family member)(3- and 6-month after recruitment)
- Academic performance (for children)(3- and 6-month after recruitment)
- Self-reported intention to quit (for smokers)(3- and 6-month after recruitment)
- Smoking cessation service use (for smokers)(3- and 6-month after recruitment)
- Children's secondhand smoke exposure (for children)(3- and 6-month after recruitment)
- Cognitive function (for children)(3- and 6-month after recruitment)
- Depression and anxiety (for smokers, family member and children)(3- and 6-month after recruitment)
- Quality of life (for smokers and family member)(3- and 6-month after recruitment)
- Family well-being (for smokers, family member and children)(3- and 6-month after recruitment)
研究者
Prof. Sophia Siu-chee Chan
Professor
The University of Hong Kong