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The cessation in pregnancy incentives trial

The Cessation in Pregnancy Incentives Trial (CPIT): a phase II randomised controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87508788
Enrollment
600
Registered
2011-09-01
Start date
2011-09-01
Completion date
Unknown
Last updated
2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking addiction Mental and Behavioural Disorders Smoking addiction

Interventions

The intervention group: The offer of incentive payments for cessation during pregnancy will be delivered by the specially trained NHS Smoking Helpline staff towards the end of the second ?trial consen
a further £50 voucher will be sent if they are self report abstinent 4 weeks after quit date corroborated by a routinely collected carbon monoxide breath test routinely taken by pharmacy services prio
a further £100 voucher will be sent if they are self report abstinent 12 weeks after quit date corroborated by either a routinely collected carbon monoxide breath test taken by pharmacy services prior
or a carbon monoxide test specially collected either in the Clinical Research Facility or by the research nurse at home
a final £200 store voucher will be given if the intervention client when contacted by NHS Smoking Helpline at 34-38 weeks gestation (about 6 months after their quit date) self report as abstinent and

Sponsors

NHS Greater Glasgow and Clyde (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. 16 years and above 2. Female 3. Pregnant 4. English speaking 5. Referred to NHS Smokefree Pregnancy Service in Greater Glasgow and Clyde 6. Successfully contacted by NHS Smoking Helpline 7. Less than 24 weeks gestation at maternity booking 8. Carbon monoxide (CO) level 7ppm or greater at maternity booking 9. Self reported smoker at maternity booking 10. Permission given at first telephone contact to pass information to the Listening Company (NHS Smoking Helpline) for further discussion about the trial

Exclusion criteria

Exclusion criteria: 1. Not pregnant 2. Unable to provide informed consent 3. Non-English speaking 4. Not living in Greater Glasgow and Clyde catchment area or referred to Greater Glasgow and Clyde Obstetric Services 5. Referred pregnant smokers who cannot be contacted by NHS Smoking Helpline 6. CO level less than 7ppm at maternity booking 7. Not self reported smoker at maternity booking 8. Permission refused at first telephone contact to pass information to the Listening Company (NHS Smoking Helpline) for further discussion about the trial

Design outcomes

Primary

MeasureTime frame
Cotinine verified cessation at 34-38 weeks gestation towards the end of pregnancy

Secondary

MeasureTime frame
The cost effectiveness of the incentives intervention strategy. This phase II trial will examine the literature related to incentives for lifestyle change, develop data collection measures and systems for this phase II trial and then test them within a trial format. This will establish data collection systems so that cost effectiveness if present can be demonstrated with appropriate confidence in a future phase III trial Other secondary outcomes 1. Engagement - 0-4 weeks after enrolment 1.1. If the participant arrives for a face to face appointment with the NHS Smokefree Pregnancy Service adviser and sets a quit date for smoking this will be marked 'yes' 1.2. If participant does not arrive at scheduled appointment or does not set a quit date will be marked 'no' 2. Quit at 4 weeks ? 4-9 weeks after enrolment 3. Available from routine 4 week telephone follow-up with the NHS Smokefree Pregnancy Service adviser 3.1. Answer yes I haven't smoked when asked ?not smoked even a single puff on a cigarette in the past 2 weeks?. This will be marked as yes on the database 3.2. Not available for telephone follow-up. This will be marked as Not Available. 3.3. When asked ?not smoked even a single puff on a cigarette in the past 2 weeks? answer no I have smoked. Database entry to quit at 4 weeks will be marked as no. 4. Birth weight of baby - The best methods to gather this data efficiently will be examined and tested.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026