Low-intensity Ecological Momentary Assessment (EMA) for Smoking Cessation Intervention and Tobacco Control Policy Evaluation: a Randomized Controlled Trial Nested Within an EMA-based Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- Incremental Behavior Change Towards Smoking Cessation (IBC-S) at 3-month follow-up
研究概览
简要总结
The EMA-based intervention in this proposal is aimed to motivate the majority of smokers who do not prefer to use traditional cessation aids for quitting and help them quit smoking. The smartphone application (app) and the EMA-based phone reminders at low cost and short intervention time make this approach attractive for the majority of smokers. Identification of accurate and specific pro-smoking cues in the real-word and real-time environmental cues via the app will provide valuable information to guide new tobacco control policies.
详细描述
Study design:
The proposed study comprises a 2-arm (allocation ratio 1:1) RCT to assess the efficacy of the EMA-based smoking cessation intervention and the EMA-based observational study. Throughout the 7-day participation, all recruited participants will complete an EoD survey and 4 time-based system-triggered EMA each day. The surveys will be prompted by a smartphone application (app) installed in their own mobile phones. The prompting time will be personalized and pre-scheduled by the participants. The information collected in the app will be used to develop an EMA-based intervention including a quit plan and 10-week quitting reminders and for an EMA-based observational study. I will randomly allocate half of the participants (intervention group) to receive the EMA-based intervention. All participants will then be contacted for a follow-up at 3- and 6-month.
Subjects:
This proposed study aims to recruit daily tobacco users, regardless of intention to quit.The inclusion criteria are: (1) daily consumption of tobacco products (including traditional cigarettes, electronic cigarettes, and heated tobacco products) in the past week; (2) age ≥18 years; (3) owning a mobile smartphone with internet access; (4) staying in Hong Kong during the 1-week EMA study period; and (5) able to read and write Chinese. Participants' smoking status will be confirmed by measuring exhaled carbon monoxide to be 4ppm or above, or saliva cotinine to be 30ng/ml or above. Because the proposed study aims to promote smoking cessation in smokers who do not plan to use smoking cessation aids, we will exclude smokers who (1) plan to use smoking cessation services or medication in the coming month or (2) using smoking cessation services, or using nicotine replacement therapy in the past 7 days. Smokers who reported having mental illnesses and female smokers who are pregnant are also excluded as they need more specific smoking cessation intervention.
Recruitment procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Daily consumption of tobacco products (including traditional cigarettes, electronic cigarettes, and heated tobacco products) in the past week;
- •Age ≥18 years;
- •Owning a mobile smartphone with internet access;
- •Staying in Hong Kong during the 1-week EMA study period;
- •Able to read and write Chinese
- •Exhaled carbon monoxide will be measured and required to be 4ppm or above, or saliva cotinine to be 30ng/ml or above
排除标准
- •Plan to use smoking cessation services or medication in the coming month
- •Using smoking cessation services, or using nicotine replacement therapy in the past 7 days
- •Having mental illnesses
- •Female smokers who are pregnant
结局指标
主要结局
Incremental Behavior Change Towards Smoking Cessation (IBC-S) at 3-month follow-up
时间窗: 3-month follow-up
Behavioral progression towards smoking cessation will be detected by 15-item Incremental Behavior Change towards Smoking Cessation. 15-item Incremental Behavior Change towards Smoking Cessation contains two parts: behavioral and cognitive changes. Item 1 to Item 12 are binary questions on a scale of 0 to 1 (0, no; 1, yes) to evaluate the behavioral changes. Cognitive changes are measured by item 13 to 15 on a scale of 0 to 4 (0, not at all; 4 always). Higher score means a better outcome.
Prevalence of biochemical validated abstinence at 3-month follow-up
时间窗: 3-month follow-up
Tobacco abstinence in the past 7 days, which is validated using an exhaled carbon monoxide level of\< 4 ppm, and a saliva cotinine level of \< 30 ng/ml. Noted: 1. Suppose participants refuse to have a face-to-face exhaled carbon monoxide test due to the pandemic of COVID-19 in Hong Kong. In that case, the outcome will be validated by a cotinine saliva test device only. 2. If participants use NRT, the outcome will be validated by exhaled carbon monoxide only.
次要结局
- Prevalence of self-reported 7-day abstinence at 6-month follow-up(6-month follow-up)
- Prevalence of biochemical validated abstinence at 6-month follow-up(6-month follow-up)
- Prevalence of self-reported 7-day abstinence at 3-month follow-up(3-month follow-up)
- Self-reported use of smoking cessation service or medication from baseline at 3-month follow-up(3-month follow-up)