Plain English Summary
Background and study aims
7 in 10 women have at least one baby, making pregnancy an opportunity to help most female smokers to quit before their own health is damaged. However less than 1 in 10 pregnant smokers make use of the offer of available support and only 1 in 30 smokers quit during pregnancy. Smoking can lead to:
1. 1 in 3 miscarriages and still births
2. Children who are less intelligent
3. Children who are more likely to have asthma
4. Children who have attention deficit hyperactivity disorder (ADHD)
5. Children who are more likely to develop cardiovascular disease as adults
Four trials in the USA have shown promising results and the use of incentives in Dundee, Scotland has led to an increase in the number of pregnant women accessing the smoking cessation (quit smoking) support available.
The results from this study will be used to design a larger study to confirm that financial incentives lead to increased uptake of smoking cessation services and/or more women quitting smoking during pregnancy. The larger study will also assess if the benefits to child and mother outweigh the extra cost of incentive voucher payments.
Who can participate?
All women who:
1. Self report as current smokers when routinely asked at maternity booking
2. Have a carbon monoxide breath test level greater than 6 parts per million
3. Are booked for maternity care in NHS Greater Glasgow and Clyde
What does the study involve?
This study will offer pregnant smokers:
1. Standard care (control group) which includes the offer of face to face support from a trained smoking cessation adviser followed by telephone support plus the offer of free nicotine replacement therapy (like nicotine gums, patches) provided by pharmacy services for up to 12 weeks to support a quit attempt.
2. Standard care plus the offer of voucher incentives (intervention group) to take part in cessation services and to quit. If smokers arrive for a face to face appointment with a cessation adviser and set a quit date they will receive £50. If they have not smoked 4 weeks later (confirmed by a breath test) they will receive £50 and a further £100 if they have not smoked after 12 weeks. If they have not smoked when they are 34 to 38 weeks pregnant / near the end of pregnancy (confirmed by urine test) they will receive a final payment of £200.
What are the possible benefits and risks of participating?
Benefits:
1. Up to £400 in monetary vouchers
2. £1000 savings on cigarettes plus the health benefits to the mother and her unborn baby
Risks:
There are no risks to the participants
Where is the study run from?
The study will take place in the West of Scotland, United Kingdom
When is study starting and how long is it expected to run for?
Approximate start date will be late 2011 and the study will last approximately 2 years
Who is funding the study?
1. Chief Scientist Office Scottish Government
2. Glasgow Centre for Population Health
3. Yorkhill Children's Foundation
4. Royal Samaritan Endowment Fund
5. Director of Public Health Research and Teaching Endowment Fund
Who is the main contact?
Professor David Tappin
david.tappin@Glasgow.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
V17.1
Study information
Scientific title
The Cessation in Pregnancy Incentives Trial (CPIT): a phase II randomised controlled trial
Acronym
CPIT
Study hypothesis
By offering financial incentives to pregnant smokers more will engage with smoking cessation services and more will quit smoking during pregnancy.
Ethics approval
West of Scotland Research Ethics Committee 2, 25/05/2011, ref: 11/AL/0204
Study design
Phase II individually randomised parallel-group controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Smoking addiction
Intervention
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 consent telephone contact call to participants who have been randomly allocated to the intervention group. A £50 store voucher will be sent by registered post if participants arrive for their first face to face appointment with the NHS Smokefree Pregnancy Service adviser and set a quit date; 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 prior to dispensing of further Nicotine Replacement Therapy (NRT); 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 to dispensing of further NRT; 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 they then attend an appointment with the trial research nurse who collects a urine/saliva sample which is negative for cotinine, a nicotine metabolite. The intervention group will also receive the offer of standard smoking cessation support starting with face to face support from an NHS Smokefree Pregnancy Service adviser followed by pharmacy dispensed Nicotine Replacement Therapy for women who decide to set a quit date and quit smoking.
The control group:
The control group will receive the offer of standard smoking cessation intervention with face to face support from an NHS Smokefree Pregnancy Service adviser followed by pharmacy dispensed Nicotine Replacement Therapy for women who set a quit date and quit smoking.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
Cotinine verified cessation at 34-38 weeks gestation towards the end of pregnancy
Secondary outcome measures
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.
Overall trial start date
01/09/2011
Overall trial end date
31/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant 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
Recruitment start date
01/09/2011
Recruitment end date
31/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
PEACH Unit
Glasgow
G3 8SJ
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde (UK)
Sponsor details
Research and Development Central Office
c/o Dr Michael Barber
Western Infirmary
38 Church Street
Glasgow
G11 6NT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (CZH/4/594)
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Funder name
Glasgow Centre for Population Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Director of Public Health Education and Research Endowment Fund Greater Glasgow & Clyde Health Board (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Yorkhill Children's Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Royal Samaritan Endowment Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22818493
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25627664
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27565625
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28728583
Publication citations
-
Protocol
Tappin DM, Bauld L, Tannahill C, de Caestecker L, Radley A, McConnachie A, Boyd K, Briggs A, Grant L, Cameron A, Macaskill S, Sinclair L, Friel B, Coleman T, The cessation in pregnancy incentives trial (CPIT): study protocol for a randomized controlled trial., Trials, 2012, 13, 113, doi: 10.1186/1745-6215-13-113.
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Results
Tappin D, Bauld L, Purves D, Boyd K, Sinclair L, MacAskill S, McKell J, Friel B, McConnachie A, de Caestecker L, Tannahill C, Radley A, Coleman T; Cessation in Pregnancy Incentives Trial (CPIT) Team, Financial incentives for smoking cessation in pregnancy: randomised controlled trial, BMJ, 2015, 350, doi: 10.1136/bmj.h134.
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Results
Bessing B, Bauld L, Sinclair L, Mackay DF, Spence W, Tappin DM, Representativeness of the participants in the smoking Cessation in Pregnancy Incentives Trial (CPIT): a cross-sectional study, Trials, 2016, 17, 1, 426, doi: 10.1186/s13063-016-1552-5.