Trial Outcomes & Findings for MiQuit Trial: Tailored Text Messages for Pregnant Women (NCT NCT02043509)

NCT ID: NCT02043509

Last Updated: 2019-07-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 407 participants
• Primary outcome timeframe: 36 weeks gestation
• Results posted on: 2019-07-15

Participant Flow

Participant milestones

Measure	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.	Control Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
Baseline to 1st Follow-up STARTED	203	204
Baseline to 1st Follow-up COMPLETED	138	157
Baseline to 1st Follow-up NOT COMPLETED	65	47
Baseline to 2nd Follow-up STARTED	203	204
Baseline to 2nd Follow-up COMPLETED	129	132
Baseline to 2nd Follow-up NOT COMPLETED	74	72

Reasons for withdrawal

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

MiQuit Trial: Tailored Text Messages for Pregnant Women

Baseline characteristics by cohort

Measure	MiQuit n=203 Participants 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.	Control n=204 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking	Total n=407 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	193 Participants n=5 Participants	192 Participants n=7 Participants	385 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.6 years STANDARD_DEVIATION 5.7 • n=5 Participants	26.4 years STANDARD_DEVIATION 5.7 • n=7 Participants	26.5 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	203 Participants n=5 Participants	204 Participants n=7 Participants	407 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United Kingdom	203 participants n=5 Participants	204 participants n=7 Participants	407 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 weeks gestation

Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.

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.

Outcome measures

Measure	MiQuit n=203 Participants 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.	Control n=204 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy.	11 Participants	4 Participants

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.

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.

Outcome measures

Measure	MiQuit n=203 Participants 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.	Control n=204 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report.	33 Participants	33 Participants

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.

The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), self-reported.

Outcome measures

Measure	MiQuit n=203 Participants 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.	Control n=204 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report.	36 Participants	28 Participants

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.

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.

Outcome measures

Measure	MiQuit n=203 Participants 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.	Control n=204 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated.	15 Participants	9 Participants

SECONDARY outcome

Timeframe: 4 weeks post-randomisation

Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.

The number of participants reporting 7-day abstinence from smoking at 4 weeks after randomisation, self-reported.

Outcome measures

Measure	MiQuit n=203 Participants 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.	Control n=204 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report.	15 Participants	7 Participants

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.

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.

Outcome measures

Measure	MiQuit n=203 Participants 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.	Control n=204 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report.	13 Participants	4 Participants

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: All participants were included in analysis. Participants lost to follow up were assumed to be smoking.

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.

Outcome measures

Measure	MiQuit n=203 Participants 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.	Control n=204 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
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	2 Participants

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: Outcomes are calculated out of 254 participants with response data at late pregnancy follow up (124 MiQuit, 130 Standard Care).

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).

Outcome measures

Measure	MiQuit n=124 Participants 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.	Control n=130 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
Number of 24 Hour Quit Attempts	2 number of events reported Interval 1.0 to 3.0	1 number of events reported Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: Outcomes are calculated out of 254 participants with response data at late pregnancy follow up (124 MiQuit, 130 Standard Care).

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).

Outcome measures

Measure	MiQuit n=124 Participants 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.	Control n=130 Participants Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
Reported Use of NHS and Other (Non-trial) Cessation Support	83 Participants	98 Participants

SECONDARY outcome

Timeframe: 36 weeks gestation

Population: All participants allocated to the trial arm were included in analysis.

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).

Outcome measures

Measure	MiQuit n=203 Participants 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.	Control Usual care plus the same standard NHS leaflet giving information and advice on stopping smoking
Number of Requests to Stop Text Support	27 Participants	—

Adverse Events

MiQuit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Joanne Emery

University of East Anglia

Email: joanne.emery@uea.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place