Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000922673
Ethics application status
Approved
Date submitted
31/07/2023
Date registered
28/08/2023
Date last updated
28/08/2023
Date data sharing statement initially provided
28/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Quitting Using Incentives Trial for a HEaLthy Pregnancy (QUIT-HELP)
Scientific title
Investigating the Efficacy and Effectiveness of Financial Incentives to Encourage Smoking Cessation in Pregnancy
Secondary ID [1] 310177 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cigarettes in pregnancy 330761 0
Condition category
Condition code
Reproductive Health and Childbirth 327593 327593 0 0
Antenatal care
Public Health 327594 327594 0 0
Health service research
Public Health 327595 327595 0 0
Health promotion/education
Mental Health 327596 327596 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326570 0
Treatment: Other
Comparator / control treatment
Women randomised to the Control group will be asked to provide CO breath analyses at routine (scheduled) antenatal appointments approximately 4 and 12 weeks after enrolment, as well as breath and urine samples at 37 weeks gestation. They will be reimbursed $50 gift voucher for their participation.
Control group
Active

Outcomes
Primary outcome [1] 335430 0
Sustained abstinence following the first antenatal visit, as assessed by piCOBaby carbon monoxide breath analysis <=3ppm at 4 and 12 weeks following the first antenatal visit and at 37 weeks gestation.
Timepoint [1] 335430 0
4 and 12 weeks following enrolment and 37 weeks gestation
Secondary outcome [1] 424502 0
Abstinence at 37 weeks gestation, as assessed by piCOBaby CO breath analysis <=3 ppm
Timepoint [1] 424502 0
37 weeks gestation
Secondary outcome [2] 424746 0
Abstinence at 6 months postpartum, as assessed by piCOBaby CO breath analysis <=3 ppm
Timepoint [2] 424746 0
6 months postpartum
Secondary outcome [3] 424898 0
A qualitative exploration of experiences and attitudes of participating mothers and health professionals regarding the intervention and the use of use of financial incentives to encourage pregnant women to quit smoking. A semi-structured in-depth interview will be conducted by a member of the research team. Interviews will be approximately 30 minutes long and will be audio-recorded.
Timepoint [3] 424898 0
For health professionals, secondary time points are 4-6 months following the commencement of the trial and again at the end of recruitment.
For pregnant women, the secondary endpoint is the end of the trial at approximately 6 months post-partum.

Eligibility
Key inclusion criteria
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)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer (REDCap). The group to which participants are assigned will be concealed until the randomisation takes place.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared at a 1:1 ratio (intervention:control) by a statistician who is not involved in the trial. The randomisation schedule will be stratified by parity (0 versus >=1) and use randomly-sized permuted blocks ranging from 4 to 6.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
The sample size calculation is based on a modest 10% improvement in sustained abstinence (from 5% to 15%) with 90% power (10% Type II error rate) and alpha of 5% (5% Type I error rate). A stratum-specific analysis of primiparous women (estimated to be 29% of the sample) will allow the detection of 15% absolute improvement in sustained abstinence, from 5% to 20% with 65% power and 5% Type I error. Increasing the required sample size by 10% for potential attrition results in a final total sample size of 414/0.9 = 460, so 230 per group. Low attrition is anticipated as the trial is embedded in routine care. No sample size estimates are provided for the qualitative evaluation component.

Quantitative analyses
The main trial analysis and the health economic analyses will be undertaken according to a pre-written Statistical Analysis Plan (SAP). The trial SAP has been prepared by the trial biostatistician. The health economic analysis will be prepared by the trial health economist.

In brief, the primary statistical analysis is estimation of the absolute difference in the prevalence of sustained abstinence based on the intention-to-treat groups, that is, comparing average outcomes between the Intervention and Control groups to which participants were randomly allocated. The primary statistical analysis is estimation of the absolute difference in the prevalence of sustained abstinence based on the intention-to-treat groups, that is, comparing average outcomes between the Intervention and Control groups to which participants were randomly allocated. During the trial we will collect information that will enable us to analyse the sensitivity of results to assumptions about non-adherence (i.e., continued smoking) and loss to follow-up, both of which are post-randomisation events that may be influenced by time-varying confounding (e.g., financial events that might influence ongoing participation). We will adopt the Russell Standard to account for missing outcome data on smoking cessation at trial completion and use multiple imputation for other missing information.

A cost-effectiveness analysis will be undertaken from the Australian Medicare perspective for cost year 2022 and consists of two parts. First, we will conduct a within-trial analysis by using data on health-care resource use and quit outcomes to report the incremental cost per quitter and the baby in the first year of life. Second, we will adapt a typical lifetime analysis which uses a probabilistic decision analytical model to assess the incremental cost per quality-adjusted life year (QALY) gained in the Australian context.

Qualitative analyses
The framework method of thematic analysis will be used to analyse the qualitative data in the study. This approach allows analysis of some specific predetermined issues, but also aims to leave space to explore other unexpected aspects of the participants’ experiences or the way they assign meaning to phenomena. Women who have been enrolled and randomised to the Intervention arm will be invited to participate in a semi-structured interview at the end of their interaction with the trial.The interview schedule will be adapted to reflect whether the participant has quit smoking or not. Qualitative data will also come from focus groups or semi-structured interviews with health professionals. The purpose is to capture their initial experiences of the trial, including barriers and enablers to delivery potential changes in their interactions with the trial, and reflective feedback on the overall trial delivery and options for future development. This data analysis approach has been effectively used in health services research, especially with multidisciplinary teams as it provides a systematic and transparent approach to analysis. The findings from this qualitative analysis will add value to interpretation of the quantitative outcome measures generated in the trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25233 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 25234 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 40906 0
5092 - Modbury
Recruitment postcode(s) [2] 40905 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 314339 0
Government body
Name [1] 314339 0
Commonwealth of Australia, Medical Research Future Fund (MRFF)
Country [1] 314339 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
School of Public Health
L5 Rundle Mall Plaza
50 Rundle Mall, Adelaide
SA 5005
Country
Australia
Secondary sponsor category [1] 316287 0
None
Name [1] 316287 0
Address [1] 316287 0
Country [1] 316287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313439 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (HREC)
Ethics committee address [1] 313439 0
Level 3, Roma Mitchell House
136 North Terrace
Adelaide, South Australia, 5000
Ethics committee country [1] 313439 0
Australia
Date submitted for ethics approval [1] 313439 0
13/02/2023
Approval date [1] 313439 0
18/04/2023
Ethics approval number [1] 313439 0
2022/HRE00310

Summary
Brief 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.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128166 0
A/Prof Lisa Smithers
Address 128166 0
University of Adelaide, School of Public Health, L5 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005
Country 128166 0
Australia
Phone 128166 0
+61416357250
Fax 128166 0
Email 128166 0
paedperiepi@adelaide.edu.au
Contact person for public queries
Name 128167 0
A/Prof Lisa Smithers
Address 128167 0
University of Adelaide, School of Public Health, L5 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005
Country 128167 0
Australia
Phone 128167 0
+61416357250
Fax 128167 0
Email 128167 0
paedperiepi@adelaide.edu.au
Contact person for scientific queries
Name 128168 0
A/Prof Lisa Smithers
Address 128168 0
University of Adelaide, School of Public Health, L5 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005
Country 128168 0
Australia
Phone 128168 0
+61416357250
Fax 128168 0
Email 128168 0
paedperiepi@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Baseline characteristics:
a. Maternal age (grouped according to <20, 20-24, 25-29, 30-34, 35-39, 40+ years)
b. Parity (0, 1, 2+)
2) Trial outcomes:
a. Randomisation group (Control or Intervention)
b. Sustained abstinence from recruitment until 37 weeks gestation or end of pregnancy
(yes/no/not known)
c. Single point-in-time abstinence at 37 weeks of gestation or end of pregnancy
(yes/no/not known)
d. Abstinence at 6 months postpartum (yes/no/not known).
When will data be available (start and end dates)?
Data will be available after completion of the trial, following data wrangling (cleaning) and at the time of acceptance of publication of the findings.
The anticipated date of completion of the trial is 31 December 2026. Allowing 1 year for cleaning and publication we anticipate data will be available 31 December 2027.
There is no end date for the availability of data.
Available to whom?
Data will be publicly available via an open-source provider (e.g. Open Science Foundation).
Available for what types of analyses?
Available for analysis of the primary (quantitative) outcome.
How or where can data be obtained?
Following acceptance of the primary publication for the trial, a de-identified dataset will be deposited in the Centre for Open Science (https://osf.io/).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19778Informed consent form  lsmithers@uow.edu.au 386277-(Uploaded-26-07-2023-11-41-14)-Study-related document.pdf
19779Ethical approval  lsmithers@uow.edu.au 386277-(Uploaded-26-07-2023-11-41-37)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.