Condition category
Not Applicable
Date applied
05/06/2019
Date assigned
05/07/2019
Last edited
09/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Offering financial incentives is one of the most effective ways of helping women to stop smoking during pregnancy. Unfortunately, most pregnant women who stop smoking are likely to return to smoking within 12 months of the infant’s birth. There is no evidence for methods that are effective at preventing these high rates of return to smoking. Financial incentives provided after the birth may help women to remain abstinent from tobacco use. The aim of this study is to assess the effectiveness and cost effectiveness of offering financial incentives to help women who are abstinent from smoking at end of pregnancy to avoid returning to smoking during the 12 months after the birth.

Who can participate?
Women at the end of their pregnancy who are confirmed as having stopped smoking during their pregnancy

What does the study involve?
Participants are randomly allocated to one of three groups: (i) no financial incentives to remain abstinent; (ii) financial incentives for the participant of £60 for remaining abstinent from smoking up to 3 months postpartum, plus a further payment of £60 to a nominated supportive person if both that person and the participant remain abstinent (total of £120), or (iii) incentives as for (ii) plus further incentives for the participant of £60 at 6, 9 and 12 months after the birth (total of £300). The smoking status of all participants is assessed at 3 and 12 months after giving birth. Interviews with participants and a focus group with stop smoking advisers collect the experiences of and views on the incentives intervention and trial processes.

What are the possible benefits and risks of participating?
The results will inform national and international policy on interventions for preventing postpartum return to smoking. For those women who are offered shopping vouchers, this may help them avoiding a return to smoking will help their health and that of their baby, now and in the longer term. All the methods of support and assessment during the study are very safe. If the researchers telephone and leave a message, it’s possible that someone else could hear the message and find out that they are taking part in the study. The researchers will not leave a message unless participants say they can.

Where is the study run from?
Five NHS Trusts in Greater Manchester (UK)

When is the study starting and how long is it expected to run for?
April 2018 to January 2022

Who is funding the study?
Greater Manchester Combined Authority (UK)

Who is the main contact?
Prof. Michael Ussher
mussher@sgul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Ussher

ORCID ID

http://orcid.org/0000-0002-0995-7955

Contact details

Institute for Social Marketing and Health
University of Stirling
Stirling
FK9 4LJ
United Kingdom
+44 (0)778 662 8572
mussher@sgul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1234

Study information

Scientific title

Three-arm randomised controlled trial of Financial Incentives for Preventing Postpartum return to Smoking: the FIPPS trial

Acronym

FIPPS

Study hypothesis

There are three hypotheses:
1. That an intervention offering twelve months of postpartum financial incentives will be significantly more effective for aiding smoking cessation up to 12 months postpartum than a no incentives condition.
2. That an intervention offering three months of postpartum incentives will be significantly more effective for aiding smoking cessation up to 12 months postpartum than a no incentives condition.
3. That an intervention offering 12 months of postpartum incentives will be significantly more effective for aiding smoking cessation up to 12 months postpartum than an intervention offering three months of postpartum incentives.

Ethics approval

Approved 31/02/2018, North West - Liverpool Central Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ; Tel: +44 (0)2071048234; Email: nrescommittee.northwest-liverpoolcentral@nhs.net), ref: 18/NW/0838

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Prevention of smoking relapse in women following the birth of a child

Intervention

The three groups are:
1. No incentives – postpartum care will proceed as usual.

2. Incentives will be offered up to three months postpartum. There will be three incentive payments of a £20 voucher. Each voucher payment will be based on self-report of not smoking a single puff of a cigarette since the birth and on expired CO validated confirmation of smoking abstinence (<8 ppm) at 1, 2 and 3 months postpartum.
Significant Other Supporter payments: Participating women will also be given the option to identify and recruit a ‘Significant Other Supporter’ (SOS) (a member of their community who agrees to support the woman to remain smoke-free, including attending smoking cessation validation visits). The women’s SOS will be offered an incentive of £60 if the woman achieves CO validated abstinence (<8 ppm) at 3 months postpartum and the SOS is also confirmed as abstinent (CO <8 ppm). The total value of incentives offered to group 2, including those offered to the participant and the SOS is £120.

3. Incentives will be offered up to 12 months postpartum. In addition to the incentives received by group 2, those in this group can receive a £60 voucher at 6, 9 and 12 months postpartum. Again, voucher payments will be dependent on CO confirmation of self-reported abstinence. The total value of incentives offered to group 3, including those offered to the participant and SOS is £300.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Smoking status at 12 months postpartum. Self-reports of having not smoked a single puff of a cigarette since the birth of the baby will be confirmed by an expired CO reading of <8 ppm, and also by saliva cotinine (only among those reporting not currently using e-cigarettes or NRT) at 12 months postpartum.

Secondary outcome measures

Self-report of smoking status at 3 months post-partum. Report of having not smoked a single puff of a cigarette since the birth of the baby will be confirmed at this time by an expired CO reading of <8 ppm.

Overall trial start date

20/04/2018

Overall trial end date

31/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. At 36 weeks gestation reports having not smoked a single puff of a cigarette since beginning a quit attempt during pregnancy
2. Expired carbon monoxide (CO) reading < 4 parts per million (ppm)
3. Aged at least 16 years
4. Intends remaining abstinent from smoking after the birth
5. Able to speak and read English
6. Willing and able to give informed consent for participation in the study

Participant type

Patient

Age group

Mixed

Gender

Female

Target number of participants

900

Participant exclusion criteria

1. At 36 weeks gestation reports having smoked even a puff of a cigarette since commencing a pregnancy quit attempt
2. Expired CO reading > 3 ppm
3. Does not intend to remain abstinent from smoking after giving birth
4. <16 years old
5. Insufficient understanding of spoken and written English

Recruitment start date

01/02/2019

Recruitment end date

31/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Pennine Acute Hospitals NHS Trust
Research and Innovation Department, Salford Royal NHS Foundation Trust, Northern Care Alliance NHS Group, Summerfield House, 1st Floor, 544 Eccles New Road, Salford
Manchester
M5 5AP
United Kingdom

Trial participating centre

Tameside and Glossop Integrated Care NHS Foundation Trust
Tameside General Hospital Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom

Trial participating centre

Manchester University NHS Foundation Trust
Cobbett House Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Bolton NHS Foundation Trust
The Royal Bolton Hospital Minerva Road Farnworth
Bolton
BL4 0JR
United Kingdom

Trial participating centre

Stockport NHS Foundation Trust
Stepping Hill Hospital Poplar Grove Hazel Grove
Stockport
SK2 7JE
United Kingdom

Sponsor information

Organisation

University of Stirling

Sponsor details

Research Office
Stirling
FK9 4LA
United Kingdom
+44 (0)1786466443
joy.taylor@stir.ac.uk

Sponsor type

University/education

Website

https://www.stir.ac.uk/

Funders

Funder type

Government

Funder name

Greater Manchester Combined Authority

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The full study team will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authors will acknowledge that the study was funded by Greater Manchester Combined Authority. Authorship will be determined in accordance with the ICMJE guidelines and other contributors will be acknowledged. Participants will not be identified in any publications. Where direct quotes are taken, no personally identifiable information will be reported. The study will produce:
1. At least two open access peer-reviewed publications
2. At least two national or international conference presentations
The researchers are preparing a protocol for publication

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Michael Ussher (mussher@sgul.ac.uk) once the main findings of the trial have been accepted for publication for up to 10 years. The researchers will decide whether to share data on an individual basis depending on the aims of the research and subject to a data sharing agreement. Data will be pseudo-anonymised i.e., it will include ethnicity, age and gender.

Intention to publish date

01/06/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/07/2019: Internal review. 06/06/2019: Trial's existence confirmed by ethics committee.