Effectiveness of an App for Tobacco Cessation in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Smoking cessation
研究概览
简要总结
Background: Tobacco use during pregnancy is one of the most modifiable causes of morbidity and mortality for both pregnant women and their fetus. Despite the fact that smoking among pregnant has decreased in recent years, smoking continues to be a major public health problem.
Hypothesis / Research question: The use of new technologies such as applications (apps) for mobile devices designed with a gamification strategy (understood as an incentive through play) could help women to quit smoking during pregnancy and in the long term. A structured App-based intervention using gamification adapted to pregnant women will decrease smoking prevalence in this population.
Objectives: To evaluate the effectiveness of an intervention against tobacco in pregnant women based on an app for tobacco abstinence. Specific objectives: 1) To determine the effectiveness of the intervention on smoking cessation during pregnancy, 2) Determine the effectiveness of the intervention in in the long term and 3) To determine the impact of the intervention to reduce smoking in pregnant women who continue smoking.
Design: Randomized, multicentre community intervention trial
Setting: Sexual and Reproductive Health Care Services of the Camp de Tarragona and Central Catalonia Primary Care Centres.
Intervention: the participants will have the usual clinical practice intervention and the intervention group (IG) will also have access to an app based on gamification, verified by coximetry during the follow-up, and with a cotinine test at the end.
Analysis: of groups "by intention to treat", abstinence rates will be compared and the determining factors will be evaluated using multivariate statistics.
Expected results: smoking cessation in the IG will be > 5%, compared to normal practice.
Applicability and Relevance: It promotes activities aimed to reduce tobacco consumption in the general population, and especially in women, in order to decrease comorbidity associated with long-term smoking, which will lead to a reduction in tobacco-related diseases in the whole population.
详细描述
Design: community-based intervention trial with simple random assignment.
Setting and study population: the study population will be drawn from the usual consultations of 4 Sexual and Reproductive Health Care Centres (ASSIR) responsible for pregnancy monitoring in the community, managed by the Catalan Health Institute (ICS) in Tarragona and Barcelona.
Study subjects: pregnant women over 18 years of age who attended the ASSIR services and consented to participate in the study and meet the inclusion criteria.
Randomisation process of the intervention: the participants included will be assigned to receive or not to receive the proposed intervention. The allocation sequence will be carried out consecutively, centralised from the Research Support Unit of the Jordi Gol Primary Care Research Institute in Tarragona, following a simple numerical randomisation ratio. No masking will be possible either for pregnant women or for ASSIR professionals; the data will be masked for the research team carrying out the statistical analyses.
Selection of the participating centres: the pregnancy monitoring centres participating in the recruitment of the study will be four, all of them from the ICS. Three in the Tarragona region (Tarragona, Reus and Valls) and a fourth in the Osona region of Barcelona (Manresa).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women smokers (report having smoked sporadically or daily in the last 30 days(*)) over 18 years of age,
- •Follow-up of pregnancy in the ASSIR in Camp de Tarragona and Barcelona of the ICS,
- •Having a mobile device with Android or iOS operating system and data connection,
- •Having skills on the use of Apps and willingness to use them (#).
- •(*) Active smoking is defined as daily or occasional smoking in the last month, regardless of the amount smoked.
- •(#) It is understood that you have skills on the use of Apps and willingness to use them if you answer affirmatively to the following questions: Have you downloaded any application on your mobile?, Would you install an application to help you quit smoking on your mobile?, Have you participated in any chat group?, and Have you played any game with your mobile device? (criteria to ensure the usability of the intervention tool).
排除标准
- •Having participated in a smoking cessation study within the last 12 months,
- •Psychiatric history that prevents or limits follow-up of the study,
- •Inability to follow up for any reason,
- •Express refusal of the patient to continue in the study.
结局指标
主要结局
Smoking cessation
时间窗: 1 year
Women who have stopped smoking during pregnancy will be scheduled to visit their health centre 12 months after the intervention to find out about their relationship with smoking.
次要结局
- Verification of smoking abstinence(1 year)