MiQuit Trial: Tailored Text Messages for Pregnant Women

NCT ID: NCT02043509

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-05-31

Brief Summary

The overall aim of the study is to estimate the likely impact of the MiQuit text message based smoking cessation service for pregnant smokers and to establish robust estimates for the key factors which would be required in order to design a larger definitive trial of this intervention(MiQuit).

These key factors include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of participants in later pregnancy; and the likely effect of MiQuit when women are offered this in National Health Service (NHS) settings.

Detailed Description

Epidemiological evidence indicates that smoking during pregnancy increases the risk of many pregnancy related complications and is associated with many adverse postnatal problems. Around 15% of women still smoke throughout their pregnancy; younger women and those from more deprived backgrounds are much more likely to smoke. Behavioural support, available through NHS Stop Smoking Services, is effective but only accessed by a minority of smokers with most trying to quit alone. For this large group, self-help interventions may be an effective alternative.

MiQuit is a 12 week tailored, self-help, text-message intervention developed for pregnant smokers. A pilot study found this was feasible and acceptable for recipients, thus if MiQuit could have such an impact in routine NHS care, its low cost would make it highly cost-effective.

Before MiQuit could be used in routine care, a definitive randomised controlled trial (RCT) would be needed but currently there is insufficient information to justify conducting this.

This pilot trial will investigate whether it is possible to evaluate MiQuit in a multi-centre RCT located within the NHS, using research network resources. This study will recruit 400 pregnant smokers who will be randomly allocated to either MiQuit or control, and will provide estimates for the parameters required for determining the necessary resources for a definitive trial. These include: the range of recruitment rates in different centres; quit rates amongst participants; feasibility of assessing smoking status of trial participants in later pregnancy and ascertainment rates obtained; and the likely effect of MiQuit when women are offered this in NHS settings.

Secondary objectives include; To estimate and model the likely effectiveness and cost effectiveness of MiQuit compared with usual care including a generic smoking cessation information leaflet; To document participants' use of MiQuit interactive features and of NHS cessation support; To assess the effect of MiQuit on social cognitive determinants of quitting smoking and; To explore participant views and experiences of using MiQuit.

The participants will be recruited before 25 weeks gestation when they attend NHS hospital clinics for routine antenatal ultrasound scans. Recruitment will take place in around 12 United Kingdom (UK) centres over a 12 month period. Follow-up will be via telephone at 1 month after randomization and again at week 36 gestation. The follow-up is over a 9 month period. If a participant reports they have stopped smoking, this "quit" will be validated with a exhaled Carbon Monoxide (CO) measurement and/or salivary cotinine measurement.

A small number of semi-structured telephone interviews will be carried out with a selection of participants from the MiQuit arm to explore their views and experience of the intervention.

Conditions

Pregnancy; Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

MiQuit

12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care

Group Type: EXPERIMENTAL

MiQuit

Intervention Type: BEHAVIORAL

MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement.

Control

Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MiQuit

MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement.

Intervention Type: BEHAVIORAL

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
• Has own 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Coleman, Professor

Role: STUDY_CHAIR

University of Nottingham

Locations

Mid Cheshire Hospitals NHS Foundation Trust

Crewe, Cheshire, United Kingdom

Chesterfield Royal Hospitals NHS Foundation Trust

Chesterfield, Derbyshire, United Kingdom

Derby Hospitals NHS Foundation Trust

Derby, Derbyshire, United Kingdom

United Lincolnshire Hospitals NHS Trust

Boston, Lincolnshire, United Kingdom

United Lincolnshire Hospitals NHS Trust

Lincoln, Lincolnshire, United Kingdom

Nottingham University Hospitals NHS Trust, City Hospital

Nottingham, Nottinghamshire, United Kingdom

Nottingham University Hospitals NHS Trust, QMC

Nottingham, Nottinghamshire, United Kingdom

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, Nottinghamshire, United Kingdom

University Hospital of North Staffordhsire NHS Trust

Stoke-on-Trent, Staffordshire, United Kingdom

Birmingham Womens NHS Foundation Trust

Birmingham, W Midlands, United Kingdom

Sandwell & West Birmingham Hospitals NHS Trust

Birmingham, West Midlands, United Kingdom

The Dudley Group NHS Foundation Trust

Dudley, West Midlands, United Kingdom

Heart of England NHS Foundation Trust

Birmingham, , United Kingdom

Central Manchester University Hosptitals NHS Foundation Trust

Manchester, , United Kingdom

University Hospitals North Midlands NHS Trust

Stafford, , United Kingdom

Countries

United Kingdom

References

Naughton F, Prevost AT, Gilbert H, Sutton S. Randomized controlled trial evaluation of a tailored leaflet and SMS text message self-help intervention for pregnant smokers (MiQuit). Nicotine Tob Res. 2012 May;14(5):569-77. doi: 10.1093/ntr/ntr254. Epub 2012 Feb 6.

Reference Type: BACKGROUND

PMID: 22311960 (View on PubMed)

Cooper S, Foster K, Naughton F, Leonardi-Bee J, Sutton S, Ussher M, Leighton M, Montgomery A, Parrott S, Coleman T. Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial. Trials. 2015 Jan 27;16:29. doi: 10.1186/s13063-014-0546-4.

Reference Type: DERIVED

PMID: 25622639 (View on PubMed)

Other Identifiers

13/EM/0427

Identifier Type: OTHER

Identifier Source: secondary_id

13113

Identifier Type: -

Identifier Source: org_study_id