Trial of financial incentives for preventing postpartum return to smoking
| ISRCTN | ISRCTN55218215 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55218215 |
| Secondary identifying numbers | https://doi.org/10.17605/OSF.IO/NCKJ9 |
- Submission date
- 05/06/2019
- Registration date
- 05/07/2019
- Last edited
- 23/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Not Applicable
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 the 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 avoid a return to smoking and 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?
Four NHS Trusts in Greater Manchester (UK)
When is the study starting and how long is it expected to run for?
February 2018 to August 2024
Who is funding the study?
Greater Manchester Combined Authority (UK)
Who is the main contact?
Prof. Michael Ussher
mussher@sgul.ac.uk
Contact information
Scientific
Institute for Social Marketing and Health
University of Stirling
Stirling
FK9 4LJ
United Kingdom
 ORCID ID |
0000-0002-0995-7955 |
|---|---|
| Phone | +44 (0)778 662 8572 |
| mussher@sgul.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Three-arm randomised controlled trial of Financial Incentives for Preventing Postpartum return to Smoking: the FIPPS trial |
| Study 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(s) | 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 |
| 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. (added 15/10/2020) In instances where it is not possible to conduct CO validation, due to COVID-19 restrictions, smoking abstinence will be by self-report alone. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 15/10/2020: Smoking status at 12 months postpartum. Self-reports of having not smoked a single puff of a cigarette since the woman’s last quit date in pregnancy 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. _____ Previous 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 | Current secondary outcome measure as of 27/02/2024: 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. Where a CO reading is not available, (e.g., due to COVID-19 restrictions), self-report alone will be assessed. Self-reported and CO-validated smoking abstinence two plus years postpartum. _____ Previous secondary outcome measure as of 15/10/2020 to 27/02/2024: 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. Where a CO reading is not available, (e.g., due to COVID-19 restrictions), self-report alone will be assessed. _____ Previous secondary outcome measure: 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 study start date | 01/02/2018 |
| Overall study end date | 14/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | 900 |
| Total final enrolment | 481 |
| Participant inclusion criteria | Current inclusion criteria as of 20/11/2020: 1. Confirms having not smoked a single puff of a cigarette for at least four weeks 2. Is between 34 weeks gestation and two weeks postpartum 3. Expired carbon monoxide (CO) reading 4. Aged at least 16 years 5. Intends remaining abstinent from smoking after the birth 6. Able to speak and read English 7. If participant needs to use a single-person, self-administered carbon monoxide (iCO) monitor, she needs to have a device (e.g., phone) that is compatible with the monitor app 8. Willing and able to give written informed consent for participation in the study _____ Previous inclusion criteria as of 15/10/2020: 1. At a time between 34 weeks gestation and 2 weeks postpartum, reports having not smoked a single puff of a cigarette since their last quit attempt in pregnancy 2. Reports having not smoked a single puff of a cigarette for at least four weeks 3. If the woman needs to use a Bedfont single-person, self-administered iCO monitor (e.g., during COVID-19 restrictions on face-to-face contact), has a device (e.g. phone) that is compatible with using the iCO monitor app 4. Expired carbon monoxide (CO) reading < 4 parts per million (ppm) 5. Aged at least 16 years 6. Intends remaining abstinent from smoking after the birth 7. Able to speak and read English 8. Willing and able to give informed consent for participation in the study _____ Previous 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 exclusion criteria | Current exclusion criteria as of 20/11/2020: 1. Reports having smoked even a single puff of a cigarette within the last four weeks 2. Is less than 34 weeks gestation or more than two weeks postpartum 3. Expired CO reading >3ppm 4. Does not intend to remain abstinent from smoking after giving birth 5. Insufficient understanding of spoken and written English 6. Needs to use single-person, self-administered iCO monitor and does not have a device (e.g., phone) that is compatible with using the iCO monitor app 7. Unwilling and or unable to give written informed consent for participation in the study _____ Previous exclusion criteria as of 15/10/2020: 1. At a time between 34 weeks gestation and 2 weeks postpartum woman reports having smoked even a single puff of a cigarette since her last quit attempt in pregnancy 2. Reports smoking even a single puff of a cigarette in the last four weeks 3. Does not have a device (e.g. phone) that is compatible with using the iCO monitor app 4. Expired CO reading > 3 ppm 5. Does not intend to remain abstinent from smoking after giving birth 6. <16 years old 7. Insufficient understanding of spoken and written English _____ Previous 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 | 31/08/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Northern Care Alliance NHS Group, Summerfield House, 1st Floor
544 Eccles New Road, Salford
Manchester
M5 5AP
United Kingdom
Fountain Street
Ashton-under-Lyne
OL6 9RW
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Sponsor information
University/education
Research Office
Stirling
FK9 4LA
Scotland
United Kingdom
| Phone | +44 (0)1786466443 |
|---|---|
| joy.taylor@stir.ac.uk | |
| Website | https://www.stir.ac.uk/ |
"ROR" |
https://ror.org/045wgfr59 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 02/08/2021 | 19/08/2021 | Yes | No | |
| Statistical Analysis Plan | 18/05/2022 | 12/04/2023 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol (other) | 26/02/2024 | 27/02/2024 | No | No | |
| Results article | 16/04/2024 | 18/04/2024 | Yes | No |
Editorial Notes
23/08/2024: The overall study end date was changed from 31/08/2024 to 14/08/2024.
19/06/2024: The overall study end date was changed from 30/06/2024 to 31/08/2024.
18/04/2024: Publication reference added.
27/02/2024: The following changes have been made:
1. A link to the protocol (not peer reviewed) for the follow-up at 2 years was added.
2. The overall study end date was changed from 30/11/2022 to 30/06/2024.
3. The secondary outcome measures were updated.
4. The intention to publish date was changed from 30/12/2023 to 30/03/2024.
20/06/2023: The intention to publish date was changed from 30/06/2023 to 30/12/2023.
12/04/2023: The following changes have been made:
1. A statistical analysis plan (SAP) link has been added.
2. The OSF registration link has been added to the protocol/serial number field.
16/11/2022: Total final enrolment added.
19/08/2021: Publication reference added.
20/11/2020: The following changes were made to the trial record:
1. The inclusion criteria were changed.
2. The exclusion criteria were changed.
15/10/2020: The following changes were made to the trial record:
1. The protocol number was changed from 1234 to Version 6.0.
2. The interventions were updated.
3. The primary outcome measure was changed.
4. The secondary outcome measures were updated.
5. The overall start date was changed from 20/04/2018 to 01/02/2018.
6. The inclusion criteria were changed.
7. The exclusion criteria were changed.
8. The recruitment end date was changed from 30/01/2021 to 31/08/2021.
9. The trial participating centre Stockport NHS Foundation Trust’ was removed.
10. The plain English summary was updated to reflect these changes.
06/04/2020: The intention to publish date has been changed from 01/06/2022 to 30/06/2023.
03/04/2020: The overall trial end date has been changed from 31/01/2022 to 30/11/2022.
26/02/2020: The recruitment end date has been changed from 31/10/2020 to 30/01/2021.
09/07/2019: Internal review.
06/06/2019: Trial's existence confirmed by ethics committee.
