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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Pregnancy Related
• Intervention / Treatment: Other: MiQuit text message support programme

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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B75 7RR
    • University Hospitals Birmingham Nhs Foundation Trust
  • Chester, United Kingdom, CH2 1UL
    • Countess of Chester Hospital NHS Foundation Trust
  • Sunderland, United Kingdom, SR4 7TP
    • City Hospitals Sunderland NHS Foundation Trust
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG1 5LE
      • Royal Berkshire NHS Foundation Trust
  • Birmingham
    • Edgbaston, Birmingham, United Kingdom, B15 2TG
      • Birmingham Womens NHS Foundation Trust
  • Cheshire
    • Crewe, Cheshire, United Kingdom, CW1 4QJ
      • Mid Cheshire Hospitals NHS Trust
  • Cumbria
    • Carlisle, Cumbria, United Kingdom, CA2 7HY
      • North Cumbria University Hospitals NHS Trust
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • University Hospitals of Derby and Burton NHS Foundation Trust
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8D
      • Plymouth Hospitals Nhs Trust
  • Greater Manchester
    • Multiple Locations, Greater Manchester, United Kingdom, M8 5RB
      • Pennine Acute Hospitals NHS Trust
  • Lancashire
    • Burnley, Lancashire, United Kingdom, BB10 2PQ
      • East Lancashire Hospitals NHS Trust
  • Lincolnshire
    • Multiple Locations, Lincolnshire, United Kingdom, LN2 5QY
      • United Lincolnshire Hospitals Trust
  • Newcastle Upon Tyne
    • Newcastle, Newcastle Upon Tyne, United Kingdom, NE1 4LP
      • Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Nottinghamshire
    • Mansfield, Nottinghamshire, United Kingdom, NG17 4JL
      • Sherwood Forest Hospitals NHS Trust
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals NHS Foundation Trust
  • Staffordshire
    • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
      • University Hospitals of North Midlands NHS Trust
  • Tyne And Wear
    • North Shields, Tyne And Wear, United Kingdom, NE29 8NH
      • Northumbria Healthcare NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. Receive MiQuit text message cessation programme.	Other: MiQuit text message support programme; MiQuit is an automated, responsive text message support programme lasting 12 weeks which sends texts containing self-help smoking cessation support and advice to participants mobile phones.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported abstinence from smoking	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.	36 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported abstinence from smoking at 4 weeks after randomisation	7 day abstinence reported at 4 weeks	4 weeks after enrolment
Abstinence from smoking at 36 weeks gestation	self-reported and biochemically validated 7 day abstinence at 36 weeks gestation	36 weeks gestation
Use of stop-smoking services	use of stop-smoking services	36 weeks gestation
Use of NHS care	Use of NHS care	At delivery
Birth weight	Weight of infant at birth	At delivery
Gestational age	Gestational age at birth	At delivery
Fetal death	Miscarriage or stillbirth	At delivery
Maternal death	Death of participant	At delivery
Health Status - baseline	Health status measured by EQ-5D-5L at baseline visit	At hospital ante-natal appointment
Health Status - 4 weeks after randomisation	Health status measured by EQ-5D-5L at 4 weeks post randomisation	4 weeks post randomisation
Health Status - 36 weeks gestation	Health status measured by EQ-5D-5L at 36 weeks gestation	36 weeks gestation
Maternal hospital admissions	Hospital admission of participant	At delivery
Infant hospital admission	Hospital admission of infant	At delivery
Staff costs	Overheads and other consumables required to deliver the MiQuit intervention and usual care	Upto 40 weeks after enrolment

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Study Director: Tim Coleman, University of Nottingham

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 17065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No