Promoting Smoking Cessation During Pregnancy: a Combined Feasibility and Pilot Trial of a Theory-based Intervention Using Narrative, Images and Embedded Behaviour Change Techniques, Delivered Via Text-messaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The aim of this study is to investigate the feasibility and likelihood of success of a narrative and image-based intervention, administered via text messages, for smoking cessation in pregnant women, prior to undertaking a large scale trial of its effectiveness. A feasibility and pilot trial will be undertaking involving 70 pregnant women who smoke in two NHS Boards.
详细描述
Smoking during pregnancy carries serious risks to mother and infant health. More babies whose mothers smoke are stillborn or die within the first year of life. Smoking during pregnancy results in increased rates of intrauterine growth retardation, preterm birth, and babies' longer-term risk of developing heart disease and diabetes. Pregnant women who smoke are more likely to experience miscarriage, placental abruption, pregnancy-induced hypertension and later conditions such as lung cancer and heart disease.
Reduction in smoking in pregnancy has been a long standing health policy target however there is limited evidence of effectiveness of many smoking cessation interventions and their uptake is generally low. We have developed, and carried out initial testing of an intervention to support smoking cessation in pregnant women using narrative, story-telling delivered via automated text-messages. The intervention aims to alter women's perceptions of risk, social norms, outcomes and self-efficacy using three key elements. 1. a narrative story of a fictional young pregnant woman 'Megan' trying to stop smoking by overcoming a series of commonplace barriers. 2) images showing the size of their fetus and its stage of development 3) an interactive 'help' function to receive a supportive, tailored response. Behaviour change techniques for smoking cessation in pregnancy are embedded in the intervention.
A randomised controlled trial is required to test the effectiveness of the intervention in reducing smoking in pregnancy. The aim of this study is to investigate the feasibility and likelihood of success of the narrative and image-based intervention for smoking cessation in pregnant women. If successful the intervention will be tested in a full-scale (Phase III) multi centre randomised controlled trial.
Objectives:
- To assess acceptability and willingness to be randomised to the narrative and image based intervention or usual care.
- To assess and compare the feasibility of recruitment strategies, the level of participants' retention in the study and engagement with the intervention.
- To assess the acceptability and likely impact of the intervention among pregnant smokers.
- To estimate the required sample size for a full trial.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 16 years of age or over,
- •Live within the catchment areas of study sites,
- •Up to and including 14 weeks of pregnancy,
- •Current smoker,
- •Own or regularly use a mobile phone with media capability,
- •Understand written English,
- •Able to give informed consent.
排除标准
- •Women who do not currently smoke,
- •Live outside the catchment areas of study sites,
- •Over 14 weeks of pregnancy,
- •Do not use or have access to a mobile phone with media capability,
- •Cannot understand written English,
- •Not able to give informed consent,
- •Already enrolled in an alternative formal smoking cessation trial at the time of referral to the study.
结局指标
主要结局
Recruitment rate
时间窗: 23 months
Progression to a full trial will require recruitment ≥50% of women who give permission to have their details passed to the research team (i.e. those who express initial interest in the study).
Drop out rate
时间窗: 23 months
Progression to a full trial will require \<30% dropout
Direction of effect
时间窗: 23 months
Progression to a full trial will require direction of effect on smoking cessation rate in favour of the intervention.
次要结局
- Engagement(23 months)
- Acceptability(23 months)
研究者
Helen Cheyne
Professor of Maternal and Child Health Research
University of Stirling