Financial Incentives for Preventing Postpartum Return to Smoking (Fipps): Study Protocol for a Three-Arm Randomised Controlled Trial

Autor: Michael Ussher, Sophie Orton, Tim Coleman, Catherine Best, Sue Cooper, Jennifer McKell, Sarah Lewis, Linda Bauld
Rok vydání: 2021
Předmět:
medicine.medical_specialty
Medicine (General)
medicine.medical_treatment
Smoking relapse prevention
Psychological intervention
Medicine (miscellaneous)
Intervention
Smoking cessation
01 natural sciences
law.invention
03 medical and health sciences
Study Protocol
0302 clinical medicine
R5-920
Randomized controlled trial
law
Postpartum
Pregnancy
Intervention (counseling)
medicine
Smoking/adverse effects
Humans
Multicenter Studies as Topic
Pharmacology (medical)
030212 general & internal medicine
0101 mathematics
Randomized Controlled Trials as Topic
Retrospective Studies
Protocol (science)
Randomised controlled trial
Motivation
business.industry
010102 general mathematics
Smoking
Postpartum Period
Infant
Retrospective cohort study
medicine.disease
Physical therapy
Financial incentives
Female
Smoking Cessation
business
Postpartum period
Intervention
randomised controlled trial
pregnancy
postpartum
smoking relapse prevention
smoking cessation
financial incentives
Zdroj: Ussher, M, Best, C, Lewis, S, McKell, J, Coleman, T, Cooper, S, Orton, S & Bauld, L 2021, ' Financial Incentives for Preventing Postpartum return to Smoking (FIPPS) : study protocol for a three-arm randomised controlled trial ', Trials, vol. 22, no. 1, pp. 512 . https://doi.org/10.1186/s13063-021-05480-6
Trials, Vol 22, Iss 1, Pp 1-16 (2021)
Trials
ISSN: 1745-6215
DOI: 10.21203/rs.3.rs-475708/v1
Popis: Background Financial incentives are an effective way of helping women to stop smoking during pregnancy. Unfortunately, most women who stop smoking at this time return to smoking within 12 months of the infant’s birth. There is no evidence for interventions that are effective at preventing postpartum smoking relapse. Financial incentives provided after the birth may help women to sustain cessation. This randomised controlled trial will assess the effectiveness and cost-effectiveness of financial incentives to help women who are abstinent from smoking at end-of-pregnancy to avoid return to smoking up to 12 months postpartum. Methods This is a UK-based, multi-centre, three-arm, superiority, parallel group, individually randomised controlled trial, with 1:1:1 allocation. It will compare the effectiveness of two financial incentive interventions with each other (one intervention for up to 3 months postpartum offering up to £120 of incentives (£60 for the participant and £60 for a significant other support); the other for up to 12 months postpartum with up to £300 of incentives (£240 for the participant and £60 for a significant other support) and with a no incentives/usual care control group. Eligible women will be between 34 weeks gestation and 2 weeks postpartum, abstinent from smoking for at least 4 weeks, have an expired carbon monoxide (CO) reading < 4 parts per million (ppm), aged at least 16 years, intend remaining abstinent from smoking after the birth and able to speak and read English. The primary outcome is self-reported, lapse-free, smoking abstinence from the last quit attempt in pregnancy until 12 months postpartum, biochemically validated by expired CO and/or salivary cotinine or anabasine. Outcomes will be analysed by intention-to-treat and regression models used to compare the proportion of abstinent women between the two intervention groups and between each intervention group and the control group. An economic evaluation will assess the cost-effectiveness of offering incentives and a qualitative process evaluation will examine barriers and facilitators to trial retention, effectiveness and implementation. Discussion This pragmatic randomised controlled trial will test whether offering financial incentives is effective and cost-effective for helping women to avoid smoking relapse during the 12 months after the birth of their baby. Trial registration International Standard Randomised Controlled Trial Number 55218215. Registered retrospectively on 5th June 2019
Databáze: OpenAIRE
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