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

Abstract

BackgroundFinancial 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. MethodsThis 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 three months postpartum offering up to £120 of incentives, the other for up to 12 months postpartum with up to £300 of incentives) and with a no incentives/usual care control group. Eligible women will be between 34 weeks gestation and two weeks postpartum, abstinent from smoking for at least four 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. DiscussionThis 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 registrationInternational Standard Randomised Controlled Trial Number: 55218215. Registered retrospectively on 5 th June 2019.

Effect of financial voucher incentives provided with UK stop smoking services on the cessation of smoking in pregnant women (CPIT III): pragmatic, multicentre, single blinded, phase 3, randomised controlled trial

“…44 unanswered questions and future research Many studies have shown a rapid return to smoking post partum, suggesting the use of continued incentive payments post partum to prevent relapse (subject of an ongoing trial, ISRCTN5521821). 19 The current trial shows a clinically important 45 46 increase in birth weight among participants who adhered to their treatment allocation (0.31 kg (95% confidence interval −0.18 to 0.80 kg); 10% of birthweight), similar to the feasibility trial 37 (0.15 kg (−0.62 to 0.80 kg); 5% of birthweight) and to application of average causal effect analysis to the French trial 43 (0.52 kg; 15% of birthweight). A meta-analysis of these and other relevant data would allow a definitive answer to be reached regarding an important birthweight increase 45 46 among those participants who quit smoking with the offer of financial incentives but would not have quit without that offer.…”