PregnancyMiQuitNCT02043509
MiQuit Trial: Tailored Text Messages for Pregnant Women
A study testing MiQuit in people with Pregnancy and Smoking, run by University of Nottingham at 15 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- What is being tested?
- MiQuit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- Feb 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- •Already enrolled in another text service to assist smoking cessation
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
Birmingham Womens NHS Foundation Trust
Birmingham, W Midlands, B15 2TG
Sandwell & West Birmingham Hospitals NHS Trust
Birmingham, West Midlands, B18 7QH
Heart of England NHS Foundation Trust
Birmingham, B9 5SS
United Lincolnshire Hospitals NHS Trust
Boston, Lincolnshire, PE21 9QS
Chesterfield Royal Hospitals NHS Foundation Trust
Chesterfield, Derbyshire, S44 5BL
Mid Cheshire Hospitals NHS Foundation Trust
Crewe, Cheshire, CW1 4QJ
Derby Hospitals NHS Foundation Trust
Derby, Derbyshire, DE22 3NE
The Dudley Group NHS Foundation Trust
Dudley, West Midlands, DY1 2HQ
United Lincolnshire Hospitals NHS Trust
Lincoln, Lincolnshire, LN12 5QY
Central Manchester University Hosptitals NHS Foundation Trust
Manchester, M13 9WL
Nottingham University Hospitals NHS Trust, City Hospital
Nottingham, Nottinghamshire, NG5 1PB
Nottingham University Hospitals NHS Trust, QMC
Nottingham, Nottinghamshire, NG7 2UH
University Hospitals North Midlands NHS Trust
Stafford, ST16 3SA
University Hospital of North Staffordhsire NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, Nottinghamshire, NG17 4JL
About this study
Official title: Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial
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.
Read the 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.
- Being tested
- MiQuit
- Keywords
- smoking cessation, pregnancy, cessation support, tailored text messages, self-help, MiQuit
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiQuitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MiQuit | Experimental | 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care Receives: Behavioral: MiQuit |
| Control | No intervention | Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy.
The primary smoking outcome measure will be the number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation.
Measured: 36 weeks gestation
Secondary outcomes (9)
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report.
The number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), self-reported.
Measured: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report.
The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), self-reported.
Measured: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated.
The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation.
Measured: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report.
The number of participants reporting 7-day abstinence from smoking at 4 weeks after randomisation, self-reported.
Measured: 4 weeks post-randomisation
7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report.
The number of participants reporting 7-day abstinence from smoking at both 4 weeks after randomisation and at follow up at the end of pregnancy (approximately 36 weeks gestation), self-reported.
Measured: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy.
The number of participants reporting 7-day abstinence from smoking at both 4 weeks after randomisation and at follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation.
Measured: 36 weeks gestation
Number of 24 Hour Quit Attempts
Number of short-term, 24 hour quit attempts noted per participant, from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation).
Measured: 36 weeks gestation
Reported Use of NHS and Other (Non-trial) Cessation Support
Reported use of any NHS cessation support or other (non-trial) cessation support (e.g. non-NHS websites), from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation).
Measured: 36 weeks gestation
Number of Requests to Stop Text Support
The number of participants in the trial arm who discontinued the text support prematurely, from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation).
Measured: 36 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Sponsor
- Investigators
- Tim Coleman, Professor, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043509
- Sponsor's protocol ID
- 13113
- Other IDs
- 13/EM/0427
- Acronym
- MiQuit
- Status last verified
- Apr 2019
- First submitted
- 14 Jan 2014
- Last updated
- 15 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22311960Cooper 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.
PubMed 25622639
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Tailored Text Message Intervention for Pregnant Smokers (MiQuit): a Pilot Trial
- ClinicalTrials.gov ID
- NCT02043509
- Acronym / sponsor ID
- MiQuit / 13113
- Keywords
- smoking cessation, pregnancy, cessation support, tailored text messages, self-help, MiQuit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Posted 15 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiQuit | Experimental | Behavioral: MiQuit12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care |
| Control | No intervention | –Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- •Already enrolled in another text service to assist smoking cessation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiQuitMiQuit 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. | Behavioural | MiQuit |
Primary outcome
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy.
Time frame: 36 weeks gestation
The primary smoking outcome measure will be the number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation.
9 secondary outcomes
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report.
Time frame: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report.
Time frame: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated.
Time frame: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report.
Time frame: 4 weeks post-randomisation
7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report.
Time frame: 36 weeks gestation
7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy.
Time frame: 36 weeks gestation
Number of 24 Hour Quit Attempts
Time frame: 36 weeks gestation
Reported Use of NHS and Other (Non-trial) Cessation Support
Time frame: 36 weeks gestation
Number of Requests to Stop Text Support
Time frame: 36 weeks gestation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22311960Naughton 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.
- Derived from this study: PubMed 25622639Cooper 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.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Coleman, Professor study chair
University of Nottingham
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiQuit in people with Pregnancy and Smoking, run by University of Nottingham at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. (time frame: 36 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043509, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.