Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000676819
Ethics application status
Approved
Date submitted
4/05/2021
Date registered
3/06/2021
Date last updated
20/04/2023
Date data sharing statement initially provided
3/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial of the impact of financial incentives on women quitting smoking in pregnancy.
Scientific title
Investigating the Feasibility and Acceptability of Financial Incentives to Encourage Smoking Cessation in Pregnancy: A Non-randomised Pilot Trial
Secondary ID [1] 304125 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cigarettes in pregnancy 321810 0
Condition category
Condition code
Public Health 319536 319536 0 0
Health promotion/education
Public Health 319537 319537 0 0
Health service research
Reproductive Health and Childbirth 319538 319538 0 0
Antenatal care
Mental Health 319539 319539 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilot trial using financial incentives to help women quit smoking in pregnancy

Financial incentives
Women who smoke in pregnancy will be offered a financial incentive ($100) to quit smoking by 4 weeks. If eligible, women will be invited to meet face-to-face with a midwifery-trained researcher for 30 minutes to qualitatively discuss being offered a financial incentive to quit smoking using a semi-structured interview schedule. This meeting will occur in the hospital where antenatal care is provided. Women will then be asked to use a calibrated CO monitor (PiCO Baby Smokerlyzer) to confirm they are a smoker and provide a baseline CO reading. The researcher will then discuss with participants and provide verbal and written information on supports available to women, which includes participants being given a study-specific brochure. There will be two forms of written information provided. The first refers to mental health services available to women at the hospital and in the community. The second refers to smoking cessation strategies and supports available to pregnant women. Four weeks later at a follow up antenatal appointment, researchers will meet with participants again. Women will meet face-to-face with a trained researcher on the project for 30 minutes at the hospital where antenatal care is provided, community centre or the participants home to qualitatively discuss their experience of being offered a financial incentive to quit using a semi-structured interview schedule. A breath sample will be collected using the CO monitor. If the CO reading for a participant is 4ppm or less, the participant will receive a $100 gift voucher for successfully quitting. If the CO reading for a participant is 5ppm or above, then the participant will receive a $50 gift voucher for their contributions to the trial.
Intervention code [1] 320457 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327398 0
Cessation of smoking in pregnancy as indicated by breathing in to the CO monitor (CO value of 4ppm or less).
Timepoint [1] 327398 0
Four weeks follow up after baseline intervention meeting
Secondary outcome [1] 394956 0
Self-reported change in smoking behaviour determined by semi-structured qualitative interview.
Timepoint [1] 394956 0
Four weeks follow up after baseline intervention meeting
Secondary outcome [2] 394957 0
Breath CO level measured using calibrated CO monitor.
Timepoint [2] 394957 0
Four weeks follow up after initial intervention meeting which included a CO breath baseline measure.
Secondary outcome [3] 394958 0
Women's perspectives about the feasibility of financial incentives for smoking cessation in pregnancy determined by semi-structured qualitative interview.
Timepoint [3] 394958 0
At initial meeting and then at 4 week follow up from initial intervention meeting.
Secondary outcome [4] 396376 0
Women's perspectives about the acceptability of financial incentives for smoking cessation in pregnancy determined by semi-structured qualitative interview.
Timepoint [4] 396376 0
At initial meeting and then at 4 week follow up from initial intervention meeting.

Eligibility
Key inclusion criteria
• Women who are currently pregnant (gestation<35 weeks) and smoke tobacco
• Aged 18 years or over
• Communicate in English without difficulty
• Receiving antenatal care from health professionals at the Northern Adelaide Local Health Network (NAHLN)
• Willing and able to give informed consent for participation in the study
Minimum age
18 Years
Maximum age
50 Years
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 meeting the researcher in the antenatal clinic

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main analysis for this study is qualitative in nature. Interactions between participants and researchers will be audio recorded and transcribed. Transcriptions will be analysed using thematic analysis. This will allow the researchers to identify and interpret important themes and differences from this data, and to understand women’s experiences, meanings, and realities around the use of CO monitoring.

Characteristics of the study sample (e.g. age, parity) and the baseline and follow-up CO levels will be described quantitatively using means and standard deviations (for continuous normally distributed variables), medians and interquartile ranges (for non-normally distributed variables), and frequencies and percentages (for categorical data).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/05/2022
Actual
8/11/2022
Date of last participant enrolment
Anticipated
17/05/2024
Actual
Date of last data collection
Anticipated
14/06/2024
Actual
Sample size
Target
15
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19267 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [2] 19268 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 33847 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 33848 0
5092 - Modbury

Funding & Sponsors
Funding source category [1] 308503 0
Charities/Societies/Foundations
Name [1] 308503 0
Channel 7 Children's Research Foundation
Country [1] 308503 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] 309355 0
None
Name [1] 309355 0
Address [1] 309355 0
Country [1] 309355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308464 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (HREC)
Ethics committee address [1] 308464 0
Ethics committee country [1] 308464 0
Australia
Date submitted for ethics approval [1] 308464 0
15/03/2021
Approval date [1] 308464 0
21/04/2021
Ethics approval number [1] 308464 0
2021/HRE00038

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110778 0
A/Prof Lisa Smithers
Address 110778 0
University of Adelaide, School of Public Health, L5 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005
Country 110778 0
Australia
Phone 110778 0
+61 416357250
Fax 110778 0
Email 110778 0
[email protected]
Contact person for public queries
Name 110779 0
Cherise Fletcher
Address 110779 0
University of Adelaide, School of Public Health, L5 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005
Country 110779 0
Australia
Phone 110779 0
+61 402055385
Fax 110779 0
Email 110779 0
[email protected]
Contact person for scientific queries
Name 110780 0
Lisa Smithers
Address 110780 0
University of Adelaide, School of Public Health, L5 Rundle Mall Plaza, 50 Rundle Mall, Adelaide, SA 5005
Country 110780 0
Australia
Phone 110780 0
+61 416357250
Fax 110780 0
Email 110780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval does not include sharing of IPD.


What supporting documents are/will be available?




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.