RecruitingACTRN12623000922673

Quitting Using Incentives Trial for a HEaLthy Pregnancy (QUIT-HELP)

Investigating the Efficacy and Effectiveness of Financial Incentives to Encourage Smoking Cessation in Pregnancy


Sponsor

University of Adelaide

Enrollment

460 participants

Start Date

Apr 15, 2024

Study Type

Interventional

Conditions

Summary

This protocol describes a 2-arm randomised controlled trial to examine the efficacy and effectiveness of financial incentives to help pregnant women quit smoking. The proposed study will involve women who are confirmed smokers at the time of their first antenatal visit. Financial incentives will be offered at three time points during pregnancy conditional on abstinence, with the value of the incentive increasing as the pregnancy progresses. The primary outcome is sustained smoking cessation through pregnancy to 37 weeks gestation, with follow up to 6 months post-partum. A qualitative evaluation will occur in conjunction with the intervention, and involve women who participated as well as health service staff.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Inclusion Criteria3

  • Women who are pregnant and smoke tobacco, with smoking status confirmed by piCOBaby breath analysis >=4 ppm at enrolment
  • Aged 18 years or older
  • At their first antenatal visit (~14 weeks pregnant)

Exclusion Criteria3

  • Any pregnant woman who does not smoke tobacco or who quit smoking in pregnancy prior to their first antenatal visit.
  • Unable to communicate in English (if translators are not available).
  • Unable to provide informed consent.

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Interventions

Women randomised to the Intervention group will be offered financial incentives in the form of voucher gift cards, for smoking abstinence as measured by CO breath analysis. The vouchers increase in va

Women randomised to the Intervention group will be offered financial incentives in the form of voucher gift cards, for smoking abstinence as measured by CO breath analysis. The vouchers increase in value during pregnancy from $50, to $150 and then $400. CO breath analyses will be conducted at routine antenatal appointments using the piCObaby smokerlyzer . Women nominate a ‘quit date’ within 2 weeks of providing informed consent. At 2 weeks following the quit date, women will be provided with $50 if they provide a negative CO breath analysis at their next routine antenatal appointment. Women will be given $150 if they provide a negative CO breath analysis at approximately 12 weeks after their quit date. At their 37-week appointment, women will provide breath and urine samples and will be given a $400 voucher upon confirmation of abstinence via CO breath analysis. The breath analysis only needs to be negative for tobacco use to receive the incentive. A CO breath analysis of >=4 ppm is considered abstinent. Abstinence will be rewarded at any stage but if participants had not quit at a previous appointment the reward will revert to the lower amount. For example, if a woman was not abstinent at 16 weeks ($0 reward) but was abstinent at 26 weeks and 37 weeks they would receive $50 and then $150, respectively. The maximum value of the financial incentive is $600. Urinary analysis will be conducted in batch testing at completion of the trial to provide further insights into tobacco use and abstinence behaviours. However, urinary analysis results will not be used to determine financial incentives.


Locations(2)

Lyell McEwin Hospital - Elizabeth Vale

SA, Australia

Modbury Hospital - Modbury

SA, Australia

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ACTRN12623000922673