The use of financial incentives for smoking cessation in pregnant women: A parallel-group randomised controlled trial protocol.

Abstract

Background and aims: Smoking cessation during pregnancy results in short- and long-term health benefits for the mother and infant. Despite public health policies and initiatives to reduce smoking, smoking in pregnancy remains unacceptably high in Australia, particularly among populations of high disadvantage. Internationally, the use of financial incentives has shown some promise in assisting pregnant women to quit smoking, but more research is needed in different contexts. This study aims to determine the efficacy, cost-effectiveness and acceptability of the use of financial incentives in Australia.

Design: 2-arm parallel-group randomised controlled trial.

Setting: Australian antenatal care setting.

Participants: Pregnant women who smoke.

Intervention: Women randomised to the intervention group will receive financial incentives of increasing value at three time points throughout their pregnancy (4 and 12 weeks from the first antenatal visit and 37 weeks gestation) upon confirmation of smoking abstinence.

Measurements: The primary comparison outcome is a composite binary measure of abstinence at three time points during pregnancy (4, 12 and 37 weeks). Smoking abstinence will be determined by a carbon monoxide breath analysis reading of ≤3 ppm. The primary statistical analysis is estimation of the absolute difference in the prevalence of abstinence at all three time points based on the intention-to-treat groups. A cost-effectiveness analysis will be undertaken to quantify the social returns of the intervention. A qualitative process evaluation will also be conducted to determine fidelity, contextual factors and the acceptability of the intervention to pregnant women and healthcare workers.

Comments: This study will be the first Australian trial of financial incentives in reducing smoking in pregnancy. The findings will provide evidence on the acceptability, effectiveness and cost-effectiveness of financial incentives to reduce smoking in pregnancy in Australia.