Condition category
Pregnancy and Childbirth
Date applied
09/10/2017
Date assigned
13/10/2017
Last edited
13/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Lifelong smokers lose 10 years of life. Smoking cessation by age 40 leads to a near normal lifespan. Eighty percent of women have a baby, most by age 40, making pregnancy an opportunity to help women quit before their health is irreversibly compromised. Few of the UK's current 130,000 pregnant smokers quit despite free counselling and Nicotine Replacement Therapy. Offering financial incentives for smoking cessation has worked in local single site trials including in Glasgow where the pilot study for this trial took place. The aim of this study is to examine the effectiveness and cost effectiveness of offering financial incentives in the form of shopping vouchers to pregnant smokers to engage with smoking cessation services, quit smoking during pregnancy and stay quit after pregnancy.

Who can participate?
Pregnant women (less than 24 weeks) aged 16 and older who smoke.

What does the study involve?
Participants are randomly allocated to one of two groups. All participants receive an offer to attend counselling sessions to help them stop smoking. Those in the first group receive a £50 shopping voucher if they provide data about their smoking late in their pregnancy and a £25 shopping voucher if they provide data six months after giving birth. Those in the second group receive the offer of up to £400 in shopping vouchers if they attend face-to-face counselling appointments and setting a quit smoking date. Participants are followed up to see if they have stopped smoking through questionnaires (confirmed by urine or saliva samples).

What are the possible benefits and risks of participating?
All the methods of support offered during the study have been shown to be very safe. Direct benefits of taking part include the 50% chance of receiving the financial incentive vouchers worth £400. However, only participants who manage to give up smoking will receive the vouchers. Giving up smoking will help the health of the woman and that of their baby in the short and longer term.
The results of the study will enable policy makers to determine whether financial incentives should be recommend for use in NHS smoking cessation services to help stop pregnant women from smoking.

Where is the study run from?
1. Wishaw General Hospital (UK)
2. Queen’s University Belfast (UK)

When is the study starting and how long is it expected to run for?
September 2017 to November 2020

Who is funding the study?
1. Cancer Research UK (UK)
2. Chest Heart and Stroke Scotland (UK)
3. The Lullaby Trust (UK)
4. National Cancer Research Institute (UK)
5. Public Health Agency for Northern Ireland (UK)
6. Scottish Government Chief Scientist Office (CSO) (UK)
7. Yorkshire Cancer Research (UK)

Who is the main contact?
Professor David M Tappin
david.tappin@glasgow.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof David M Tappin

ORCID ID

http://orcid.org/0000-0001-8914-055X

Contact details

University of Glasgow
Scottish Cot Death Trust
5th Floor
West Glasgow Ambulatory Care Hospital
Dalnair Street
Yorkhill
Glasgow
G3 8SJ
United Kingdom
+44 7784 304568
david.tappin@glasgow.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36323

Study information

Scientific title

The Smoking Cessation in Pregnancy Incentives Trial: A multi-centre phase III randomised controlled trial

Acronym

CPIT III

Study hypothesis

The aim of this study is to conduct a pivotal phase III randomised controlled multi-centre trial to examine the effectiveness and cost effectiveness of offering financial incentives in the form of shopping vouchers to pregnant smokers to engage with smoking cessation services, quit smoking during pregnancy and stay quit after pregnancy.

Ethics approval

West of Scotland REC 4, 16/08/2017, ref: 17/WS/0173

Study design

Randomised; Interventional; Design type: Prevention, Other

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Other obstetric conditions, not elsewhere classified

Intervention

Participants are randomly allocated to either the intervention or the control group.

The intervention group and control group receive the offer of smoking cessation services support which includes a face to face counselling appointment (in some areas within individual trial sites, the face to face contact may be within pharmacy services). Participants in both groups receive a £50 shopping voucher if they provide data at the primary outcome time point (late pregnancy) and a £25 shopping voucher if they provide data at the secondary outcome time point (6 months post-partum). (If a participant does not provide primary outcome data, they are still able to receive a £25 shopping voucher if they provide secondary outcome data).

Intervention:
In addition, the intervention group receive the offer of up to £400 of shopping vouchers: £50 for attending the first routine face-to-face counselling appointment at the smoking services support meeting and setting a quit smoking date, £50 if quit 4 weeks later verified by exhaled carbon monoxide (CO) <10 parts/million, £100 if CO verified quit 12 weeks post quit date, £200 if CO verified quit at 34-38 weeks gestation.

Control group:
The control group receives the offer of smoking cessation services support which includes a face to face counselling appointment. They also receive a £50 shopping voucher if they provide data at the primary outcome time point (late pregnancy) and a £25 shopping voucher if they provide data at the secondary outcome time point (6 months post-partum).

Intervention type

Other

Phase

Drug names

Primary outcome measures

Self-reported abstinence from smoking for at least eight weeks prior to 34-38 weeks gestation verified by cotinine and/or anabasine in urine/saliva.

Secondary outcome measures

Cotinine and/or anabasine verified self-reported continuous abstinence from smoking until six months after birth, birth weight, cost effectiveness (using the EQ-5D as the measure of utility) and process evaluation.

Overall trial start date

01/09/2017

Overall trial end date

30/11/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Self-reported smoker
2. >= 16 years
3. Pregnant less than 24 weeks
4. English speaking

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 940; UK Sample Size: 940

Participant exclusion criteria

1. Non-smoker
2. <16 years
3. Pregnant > = 24 weeks
4. Non-English speaking

Recruitment start date

01/11/2017

Recruitment end date

28/02/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wishaw General Hospital
50 Netherton Street
Wishaw
ML2 0DP
United Kingdom

Trial participating centre

Queen’s University Belfast
Royal Victoria Hospital Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde

Sponsor details

Clinical Research & Development
West Glasgow Ambulatory Care Hospital
Dalnair Street
Yorkhill
Glasgow
G3 8SJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Chest Heart and Stroke Scotland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Lullaby Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Cancer Research Institute

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Public Health Agency for Northern Ireland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Scottish Government Chief Scientist Office (CSO)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Yorkshire Cancer Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trial results will be submitted for publication in a high-impact peer reviewed journal one year after the trial end date. The trial protocol will be submitted for publication in a peer reviewed journal in Spring 2018.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

28/02/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes