Pregnancy, Smoking
Conditions
Keywords
smoking cessation, pregnancy, cessation support, tailored text messages, self-help, MiQuit
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.
Interventions
BEHAVIORALMiQuit
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.
Sponsors
University of Cambridge
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report. | 36 weeks gestation | The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), self-reported. |
| 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated. | 36 weeks gestation | 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. |
| 7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report. | 4 weeks post-randomisation | The number of participants reporting 7-day abstinence from smoking at 4 weeks after randomisation, self-reported. |
| 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report. | 36 weeks gestation | 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. |
| Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report. | 36 weeks gestation | 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. |
| Number of 24 Hour Quit Attempts | 36 weeks gestation | 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). |
| Reported Use of NHS and Other (Non-trial) Cessation Support | 36 weeks gestation | 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). |
| Number of Requests to Stop Text Support | 36 weeks gestation | 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). |
| 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy. | 36 weeks gestation | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MiQuit 12 weeks of MiQuit text support plus a standard NHS leaflet giving information and advice on stopping smoking in addition to usual care
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. | 203 |
| Control Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking | 204 |
| Total | 407 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline to 1st Follow-up | Lost to Follow-up | 61 | 47 |
| Baseline to 1st Follow-up | Withdrawal by Subject | 4 | 0 |
| Baseline to 2nd Follow-up | Lost to Follow-up | 67 | 67 |
| Baseline to 2nd Follow-up | Withdrawal by Subject | 7 | 5 |
Baseline characteristics
| Characteristic | Control | MiQuit | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 10 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 192 Participants | 193 Participants | 385 Participants |
| Age, Continuous | 26.4 years STANDARD_DEVIATION 5.7 | 26.6 years STANDARD_DEVIATION 5.7 | 26.5 years STANDARD_DEVIATION 5.7 |
| Region of Enrollment United Kingdom | 204 participants | 203 participants | 407 participants |
| Sex: Female, Male Female | 204 Participants | 203 Participants | 407 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 203 | 0 / 204 |
| serious Total, serious adverse events | 0 / 203 | 0 / 204 |
Outcome results
Primary
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.
Time frame: 36 weeks gestation
Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiQuit | Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. | 11 Participants |
| Control | Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy. | 4 Participants |
95% CI: [0.93, 9.35]
Secondary
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.
Time frame: 4 weeks post-randomisation
Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiQuit | 7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report. | 15 Participants |
| Control | 7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report. | 7 Participants |
95% CI: [0.89, 5.46]
Secondary
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.
Time frame: 36 weeks gestation
Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiQuit | 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy. | 8 Participants |
| Control | 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy. | 2 Participants |
95% CI: [0.9, 17.36]
Secondary
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.
Time frame: 36 weeks gestation
Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiQuit | 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report. | 13 Participants |
| Control | 7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report. | 4 Participants |
95% CI: [1.14, 10.69]
Secondary
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.
Time frame: 36 weeks gestation
Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiQuit | 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated. | 15 Participants |
| Control | 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated. | 9 Participants |
95% CI: [0.72, 4.03]
Secondary
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.
Time frame: 36 weeks gestation
Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiQuit | 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report. | 36 Participants |
| Control | 7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report. | 28 Participants |
95% CI: [0.79, 2.31]
Secondary
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.
Time frame: 36 weeks gestation
Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiQuit | Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report. | 33 Participants |
| Control | Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report. | 33 Participants |
95% CI: [0.61, 1.75]
Secondary
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).
Time frame: 36 weeks gestation
Population: Outcomes are calculated out of 254 participants with response data at late pregnancy follow up (124 MiQuit, 130 Standard Care).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MiQuit | Number of 24 Hour Quit Attempts | 2 number of events reported |
| Control | Number of 24 Hour Quit Attempts | 1 number of events reported |
p-value: 0.118Mann-Whitney U-test
Secondary
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).
Time frame: 36 weeks gestation
Population: All participants allocated to the trial arm were included in analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiQuit | Number of Requests to Stop Text Support | 27 Participants |
Secondary
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).
Time frame: 36 weeks gestation
Population: Outcomes are calculated out of 254 participants with response data at late pregnancy follow up (124 MiQuit, 130 Standard Care).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MiQuit | Reported Use of NHS and Other (Non-trial) Cessation Support | 83 Participants |
| Control | Reported Use of NHS and Other (Non-trial) Cessation Support | 98 Participants |