O'Donnell Rachel, Howell Rebecca, Henderson Tracy, Sinclair Laura, Mather Karen, McMeekin Nicola, Semple Sean
Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland, UK
Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland, UK.
BMJ Open. 2025 Aug 21;15(8):e107161. doi: 10.1136/bmjopen-2025-107161.
The harmful health effects of children's exposure to secondhand smoke (SHS) are well established. Most SHS exposure now occurs in the home, in low-income households. Previous research suggests that using nicotine replacement therapy (NRT) in the home can help with temporary smoking abstinence and could reduce smoking indoors. This pilot randomised controlled trial tests the feasibility of providing parents, carers and relatives with posted-to-home nicotine replacement therapy alongside fortnightly telephone support to reduce children's exposure to SHS.
100 participants are being recruited through existing National Health Service (NHS) Lanarkshire initiatives and social media. Parents/carers who are at least 18 years old, smoke in the home and care for one or more children aged 0-16 years are eligible to take part. Participants are randomised to either the intervention (Group A) or control (Group B) arm. Group A receives NRT posted to their home for 12 weeks free of charge, alongside fortnightly telephone calls and materials to support them in reducing children's exposure to SHS. Group B is signposted to the Scottish Government's 'Take it Right Outside' website which provides interactive advice on creating a smoke-free home. To quantify the child's exposure to SHS, participants instal an air quality monitor to measure fine particulate matter (PM) concentrations in their living room for 7 days at baseline and 12-week follow-up and/or collect and post saliva samples from their youngest child (age 5 or over) for cotinine analysis. Qualitative interviews explore intervention experience, NRT use and adherence and changes to home-smoking behaviours/smoking-related expenditure. Descriptive data analyses will be performed to address the feasibility of recruitment, randomisation, retention and adherence, data collection and intervention delivery. Analysis will also include pre/post changes (paired t-test) in both child's salivary cotinine and PM levels to provide preliminary data on intervention effectiveness and difference between the intervention and control arms of the study. Health economics and resource use data will be collected and assessed for completeness, to test the process of data collection and estimate mean cost of both study arms.
NHS ethical approval has been obtained by the West of Scotland Research Ethics Service (15 December 2023, ref 23/WS/0153; 13 December 2024, ref AM01). The findings will be disseminated to participants, funders, NHS Lanarkshire and other health services, and in peer-reviewed journals and academic conferences. Findings will inform new approaches that are timely and important, providing valuable evidence to help reduce children's exposure to SHS in the home in Scotland and elsewhere.
ISRCTN79307718.
儿童接触二手烟对健康的有害影响已得到充分证实。目前，大多数二手烟暴露发生在低收入家庭的家中。先前的研究表明，在家中使用尼古丁替代疗法（NRT）有助于暂时戒烟，并可减少室内吸烟。这项试点随机对照试验旨在测试向父母、照顾者和亲属提供邮寄到家的尼古丁替代疗法以及每两周一次的电话支持，以减少儿童二手烟暴露的可行性。
通过现有的苏格兰国民保健服务（NHS）拉纳克郡项目和社交媒体招募100名参与者。年龄至少18岁、在家中吸烟且照顾一名或多名0至16岁儿童的父母/照顾者有资格参与。参与者被随机分配到干预组（A组）或对照组（B组）。A组免费收到邮寄到家的NRT，为期12周，同时每两周进行一次电话沟通，并提供相关材料，以帮助他们减少儿童二手烟暴露。B组被引导至苏格兰政府的“到户外吸烟”网站，该网站提供有关创建无烟家庭的互动建议。为了量化儿童接触二手烟的情况，参与者在基线和12周随访时，在客厅安装空气质量监测器，测量7天的细颗粒物（PM）浓度，和/或从最小的孩子（5岁及以上）采集并邮寄唾液样本进行可替宁分析。定性访谈将探讨干预体验、NRT的使用和依从性以及家庭吸烟行为/与吸烟相关支出的变化。将进行描述性数据分析，以评估招募、随机分组、保留率和依从性、数据收集以及干预实施的可行性。分析还将包括儿童唾液可替宁和PM水平的前后变化（配对t检验），以提供关于干预效果以及研究干预组和对照组之间差异的初步数据。将收集并评估健康经济学和资源使用数据的完整性，以测试数据收集过程，并估计两个研究组的平均成本。
苏格兰西部研究伦理服务机构已获得NHS伦理批准（2023年12月15日，参考号23/WS/0153；2024年12月13日，参考号AM01）。研究结果将向参与者、资助者、NHS拉纳克郡及其他卫生服务机构公布，并发表在同行评审期刊和学术会议上。研究结果将为及时且重要的新方法提供参考，为帮助减少苏格兰及其他地区儿童在家中接触二手烟提供有价值的证据。
ISRCTN79307718。
