Clinical trial NCT03231553: Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy
Official title: RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Pregnancy Related
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

To efficiently determine whether or not MiQuit works for smoking cessation, we are conducting a third RCT with an almost identical design. The efficacy of the MiQuit system will be assessed by combining the findings, using Trial Sequential Analysis methods, from this trial with the findings from the previous two MiQuit trials. Without requiring an expensive, large RCT this study will tell whether or not MiQuit is efficacious for smoking cessation in pregnancy.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Self-reported abstinence from smoking
timeFrame: 36 weeks gestation
Secondary outcomes:
measure: Self-reported abstinence from smoking at 4 weeks after randomisation
timeFrame: 4 weeks after enrolment
measure: Abstinence from smoking at 36 weeks gestation
timeFrame: 36 weeks gestation
measure: Use of stop-smoking services
timeFrame: 36 weeks gestation
measure: Use of NHS care
timeFrame: At delivery
measure: Birth weight
timeFrame: At delivery
measure: Gestational age
timeFrame: At delivery
measure: Fetal death
timeFrame: At delivery
measure: Maternal death
timeFrame: At delivery
measure: Health Status - baseline
timeFrame: At hospital ante-natal appointment
measure: Health Status - 4 weeks after randomisation
timeFrame: 4 weeks post randomisation
measure: Health Status - 36 weeks gestation
timeFrame: 36 weeks gestation
measure: Maternal hospital admissions
timeFrame: At delivery
measure: Infant hospital admission
timeFrame: At delivery
measure: Staff costs
timeFrame: Upto 40 weeks after enrolment
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
state: Berkshire
city: Edgbaston
country: United Kingdom
facility: Birmingham Womens NHS Foundation Trust
state: Birmingham
city: Crewe
country: United Kingdom
facility: Mid Cheshire Hospitals NHS Trust
state: Cheshire
city: Carlisle
country: United Kingdom
facility: North Cumbria University Hospitals NHS Trust
state: Cumbria
city: Derby
country: United Kingdom
facility: University Hospitals of Derby and Burton NHS Foundation Trust
state: Derbyshire
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
state: Devon
city: Multiple Locations
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
state: Greater Manchester
city: Burnley
country: United Kingdom
facility: East Lancashire Hospitals NHS Trust
state: Lancashire
city: Multiple Locations
country: United Kingdom
facility: United Lincolnshire Hospitals Trust
state: Lincolnshire
city: Newcastle
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust
state: Newcastle Upon Tyne
city: Mansfield
country: United Kingdom
facility: Sherwood Forest Hospitals NHS Trust
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
state: Oxfordshire
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
state: Tyne And Wear
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Chester
country: United Kingdom
facility: Countess of Chester Hospital NHS Foundation Trust
city: Sunderland
country: United Kingdom
facility: City Hospitals Sunderland NHS Foundation Trust
Study officials:
affiliation: University of Nottingham
name: Tim Coleman
role: STUDY_DIRECTOR
References:
citation: Coleman T, Clark M, Welch C, Whitemore R, Leonardi-Bee J, Cooper S, Hewitt C, Jones M, Sutton S, Watson J, Daykin K, Ussher M, Parrott S, Naughton F. Effectiveness of offering tailored text message, self-help smoking cessation support to pregnant women who want information on stopping smoking: MiQuit3 randomised controlled trial and meta-analysis. Addiction. 2022 Apr;117(4):1079-1094. doi: 10.1111/add.15715. Epub 2021 Nov 5.
citation: Whitemore R, Leonardi-Bee J, Naughton F, Sutton S, Cooper S, Parrott S, Hewitt C, Clark M, Ussher M, Jones M, Torgerson D, Coleman T. Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis. Trials. 2019 May 22;20(1):280. doi: 10.1186/s13063-019-3341-4.