Smoking CessationNCT03231553
Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy
A study testing MiQuit text message support programme in people with Smoking Cessation and Pregnancy Related, run by University of Nottingham at 17 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Smoking Cessation, Pregnancy Related
- What is being tested?
- MiQuit text message support programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- 30 Nov 2017to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Owns 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
- Already enrolled in a smoking cessation study
- Having already participated in the study in an earlier pregnancy
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B75 7RR
East Lancashire Hospitals NHS Trust
Burnley, Lancashire, BB10 2PQ
North Cumbria University Hospitals NHS Trust
Carlisle, Cumbria, CA2 7HY
Countess of Chester Hospital NHS Foundation Trust
Chester, CH2 1UL
Mid Cheshire Hospitals NHS Trust
Crewe, Cheshire, CW1 4QJ
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, Derbyshire, DE22 3NE
Birmingham Womens NHS Foundation Trust
Edgbaston, Birmingham, B15 2TG
Sherwood Forest Hospitals NHS Trust
Mansfield, Nottinghamshire, NG17 4JL
Pennine Acute Hospitals NHS Trust
Multiple Locations, Greater Manchester, M8 5RB
United Lincolnshire Hospitals Trust
Multiple Locations, Lincolnshire, LN2 5QY
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, Newcastle Upon Tyne, NE1 4LP
Northumbria Healthcare NHS Foundation Trust
North Shields, Tyne and Wear, NE29 8NH
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8D
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, RG1 5LE
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
City Hospitals Sunderland NHS Foundation Trust
Sunderland, SR4 7TP
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Pregnancy Related
- Being tested
- MiQuit text message support programme
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiQuit text message support programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MiQuit text message support programme |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 weeks gestation
Secondary outcomes (14)
Self-reported abstinence from smoking at 4 weeks after randomisation
7 day abstinence reported at 4 weeks
Measured: 4 weeks after enrolment
Abstinence from smoking at 36 weeks gestation
self-reported and biochemically validated 7 day abstinence at 36 weeks gestation
Measured: 36 weeks gestation
Use of stop-smoking services
use of stop-smoking services
Measured: 36 weeks gestation
Use of NHS care
Use of NHS care
Measured: At delivery
Birth weight
Weight of infant at birth
Measured: At delivery
Gestational age
Gestational age at birth
Measured: At delivery
Fetal death
Miscarriage or stillbirth
Measured: At delivery
Maternal death
Death of participant
Measured: At delivery
Health Status - baseline
Health status measured by EQ-5D-5L at baseline visit
Measured: At hospital ante-natal appointment
Health Status - 4 weeks after randomisation
Health status measured by EQ-5D-5L at 4 weeks post randomisation
Measured: 4 weeks post randomisation
Health Status - 36 weeks gestation
Health status measured by EQ-5D-5L at 36 weeks gestation
Measured: 36 weeks gestation
Maternal hospital admissions
Hospital admission of participant
Measured: At delivery
Infant hospital admission
Hospital admission of infant
Measured: At delivery
Staff costs
Overheads and other consumables required to deliver the MiQuit intervention and usual care
Measured: Upto 40 weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start30 Nov 2017
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Coleman, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231553
- Sponsor's protocol ID
- 17065
- Status last verified
- Apr 2020
- First submitted
- 20 Jul 2017
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34636086Whitemore 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.
PubMed 31118090
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT and Meta-analysis Testing Effectiveness and Cost-effectiveness of a Tailored Text Message Programme (MiQuit) for Smoking Cessation in Pregnancy
- ClinicalTrials.gov ID
- NCT03231553
- Acronym / sponsor ID
- 17065
- Conditions
- Smoking Cessation, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: MiQuit text message support programmeReceive 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. |
| 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. |
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 (3 listed)
- 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
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 |
|---|---|---|
| MiQuit text message support programmeMiQuit 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. | Other | Intervention |
Primary outcome
Self-reported abstinence from smoking
Time frame: 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.
14 secondary outcomes
Self-reported abstinence from smoking at 4 weeks after randomisation
Time frame: 4 weeks after enrolment
Abstinence from smoking at 36 weeks gestation
Time frame: 36 weeks gestation
Use of stop-smoking services
Time frame: 36 weeks gestation
Use of NHS care
Time frame: At delivery
Birth weight
Time frame: At delivery
Gestational age
Time frame: At delivery
Fetal death
Time frame: At delivery
Maternal death
Time frame: At delivery
Health Status - baseline
Time frame: At hospital ante-natal appointment
Health Status - 4 weeks after randomisation
Time frame: 4 weeks post randomisation
Health Status - 36 weeks gestation
Time frame: 36 weeks gestation
Maternal hospital admissions
Time frame: At delivery
Infant hospital admission
Time frame: At delivery
Staff costs
Time frame: Upto 40 weeks after enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Derived from this study: PubMed 34636086Coleman 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.
- Derived from this study: PubMed 31118090Whitemore 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.
- Individual participant dataSharing planned: No
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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 study director
University of Nottingham
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiQuit text message support programme in people with Smoking Cessation and Pregnancy Related, run by University of Nottingham at 17 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 3 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 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-reported abstinence from smoking (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 NCT03231553, 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 21 Apr 2020.