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临床试验/NCT03231553
NCT03231553已完成不适用

RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy

University of Nottingham17 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
17
主要终点
Self-reported abstinence from smoking

研究概览

简要总结

The trial aims to determine whether or not MiQuit (text-message support programme) is effective when offered in addition to standard behavioural support for smoking cessation in pregnancy.

详细描述

Smoking in pregnancy is expensive; in the UK in 2010 the annual smoking-attributable maternal and infant health care costs were estimated at up to £87.5 million. In high income countries 13% to 25% of pregnant women smoke and rates are increasing in developing ones. In the UK in 2010 26% of pregnant women smoked with highest rates seen amongst younger, socially disadvantaged women.

However, pregnancy is the life event which most motivates smoking cessation attempts and 50+% of pregnant smokers try stopping, hence smoking cessation support offered in pregnancy is likely to be especially beneficial. Regrettably, in pregnancy, there is only strong efficacy evidence for using either face-to-face or 'self-help' stop smoking support. Although nicotine replacement therapy (NRT) is widely-used by UK pregnant smokers this has at best, borderline efficacy.

Self-help support (SHS) almost doubles the likelihood of smoking cessation in late pregnancy. However SHS programmes which help pregnant smokers to quit were all developed before easily-accessible technologies became widely available.

Text message SHS smoking cessation programmes are highly-acceptable; those trialled with non-pregnant smokers in the US and UK have demonstrated efficacy. Unfortunately, neither programme is appropriate in pregnancy as they make no mention of pregnancy which for most pregnant smokers is the very reason they try quitting; consequently many pregnant smokers would likely find these programmes' advice irrelevant and ignore it.

Funded by CRUK to remedy the lack of acceptable self-help cessation support for pregnant smokers, we developed MiQuit, a text-message, smoking cessation SHS programme for pregnant smokers. MiQuit advice is relevant to pregnancy as it is highly-tailored to gestation. We evaluated MiQuit in two RCTs. The first CRUK-funded trial (n=207) demonstrated acceptability. Subsequently, with NIHR funding we refined MiQuit and tested this in a second RCT which demonstrated the feasibility of recruiting from UK National Health Service (NHS) settings to a multi-centre RCT. Again estimated efficacy was encouraging; in MiQuit and control groups, prolonged abstinence from smoking, validated in late pregnancy was 5.4% and 2.0% respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

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

  • •Pregnant and less than 25 weeks gestation
  • •Smoking at least 5 cigarettes per day pre-pregnancy
  • •Smoking at least 1 cigarette on a typical day during pregnancy
  • •Aged 16 or over
  • •Agrees to accept information to assist cessation
  • •Owns or has primary use of a mobile phone
  • •Familiar with sending and receiving text messages
  • •Able to understand written English (text messages are in English only) and consent issues explained in English.
  • •Able to give informed consent

排除标准

  • •Already enrolled in another text service to assist smoking cessation
  • •Already enrolled in a smoking cessation study
  • •Having already participated in the study in an earlier pregnancy

研究组 & 干预措施

Intervention

Experimental

Receive usual NHS antenatal care and any NHS smoking cessation support which they choose to access plus an NHS leaflet giving advice on stopping smoking.

Receive MiQuit text message cessation programme.

干预措施: MiQuit text message support programme (Other)

Control

No Intervention

Receive usual NHS antenatal care and any NHS smoking cessation support which they choose to access plus an NHS leaflet giving advice on stopping smoking.

结局指标

主要结局

Self-reported abstinence from smoking

时间窗: 36 weeks gestation

Self-reported smoking abstinence from 4 weeks after enrolment until 36 weeks gestation, with no more than 5 cigarettes smoked in total between these time points, as reported and biochemically validated at 36 weeks using a cut-point used in the previous two trials.

次要结局

  • Staff costs(Upto 40 weeks after enrolment)
  • Self-reported abstinence from smoking at 4 weeks after randomisation(4 weeks after enrolment)
  • Abstinence from smoking at 36 weeks gestation(36 weeks gestation)
  • Birth weight(At delivery)
  • Health Status - 36 weeks gestation(36 weeks gestation)
  • Health Status - 4 weeks after randomisation(4 weeks post randomisation)
  • Use of stop-smoking services(36 weeks gestation)
  • Use of NHS care(At delivery)
  • Gestational age(At delivery)
  • Fetal death(At delivery)
  • Maternal death(At delivery)
  • Health Status - baseline(At hospital ante-natal appointment)
  • Maternal hospital admissions(At delivery)
  • Infant hospital admission(At delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (17)

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