ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001278527

Ethics application status

Approved

Date submitted

6/10/2015

Date registered

24/11/2015

Date last updated

11/02/2021

Date data sharing statement initially provided

11/02/2021

Date results information initially provided

11/02/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

“Stop Smoking in its Tracks”: a single arm intervention study of a smoking cessation program for women receiving maternity care through the Birthing in Our Community program. A sub-study of the Indigenous Birthing in an Urban Setting (IBUS) study

Scientific title

Assessment of the acceptability, feasibility and impact on smoking cessation, of an intensive smoking cessation intervention, including financial incentives, among pregnant Indigenous women reporting daily smoking and receiving maternity care through the Birthing in Our Community program.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Smoking cessation

Reduction in smoking

Condition category

Condition code

Public Health

Health service research

Reproductive Health and Childbirth

Antenatal care

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. Assessment of all women: In accordance with the Queensland Clinical Practice Guideline for Smoking Cessation in Pregnancy, all BiOC-enrolled women will be assessed at their first antenatal visit for smoking status, smoking history and nicotine dependence using a motivational approach.
2. Initial counselling by the midwife to motivate a quit attempt: The midwife will attempt to motivate women to make a quit attempt using brief advice, provision of written materials and offers of significant support through the SST program. The benefits of quitting smoking will be briefly discussed and women will be strongly advised to quit smoking as soon as possible in the interests of both their baby’s and their own health. A brochure on reasons for quitting will be used as a prompt for discussions. Women who smoke will be offered the opportunity to enrol in the SST program. Those not interested in participating or who are ineligible will receive usual care through BiOC.
3. First follow-up by Indigenous workers in the SST team: Following recruitment and consent, the SST staff will provide additional support to motivate a quit attempt: counselling, written materials, measurement of expired CO using the smokerlyzer and offers of significant support. Participants will again be counselled on the benefits of quitting smoking and will be strongly advised to quit smoking as soon as possible in the interests of both their baby’s and their own health. The brochure on reasons for quitting will again be used as a prompt for discussions. Women will be encouraged to identify and articulate their own views on the benefits of quitting. Additionally women will be asked to blow in a smokerlyzer which measures expired CO. The smokerlyzers used in this study provide immediate readings of the woman’s expired CO, her estimated carboxyhaemoglobin (COHb) and estimated foetal carboxyhaemoglobin (FCOHb). These readings will be used as a motivational tool to encourage the woman to quit. The staff member will emphasise her belief in the woman’s ability to quit and her willingness to support the woman to do so. They will then ask the woman to make a commitment to make a quit attempt.
4. Committing to try to quit: Women who are willing to make a commitment to try to quit will be asked to complete a Commitment Contract stating the reasons she wants to quit and that she is willing to try. The contract will also be signed by the SST staff member, to commit to supporting the woman’s quit attempt. The staff member will assist women to identify potential barriers, strategies to overcome these barriers and other sources of support for her quit attempt. A brochure providing advice on cessation strategies will be given to each woman attempting to quit.
5. Follow-up support to women trying to quit: SST staff will undertake follow-up visits with women wanting to try to quit. At each of these visits, progress will be assessed, positive feedback given, and ongoing support and advice provided. These will occur: a) Twice a week for two weeks; b) then weekly for four weeks; c) then fortnightly until the baby is born.
Frequent visits are required early in a quit attempt as this is the period when relapse is common. The visits will mostly be home visits, although they may be undertaken at the clinic if the woman is attending the clinic for other reasons. For example, most fortnightly visits for women in their third trimester could be scheduled on the same day as their fortnightly antenatal visit. These visits will last approximately 30 to 60 minutes, as necessary.
6. Free Nicotine Replacement Therapy (NRT): Intermittent forms of NRT (inhalers, gum, lozenges etc) will be offered to women who are unable to quit after two attempts without NRT, or earlier if the woman requests it. There will be no cost to the woman for this NRT. Women will be instructed by the SST staff on the best way to use these products safely and effectively. Free NRT will also be made available to household members making a quit attempt if they have no contraindications to its use. Training will be provided to all SST staff in the appropriate use of NRT, and a standard list of contraindications will be used.
7. Household members: Other members of the woman’s household will be opportunistically targeted, either through contact during a home visit, while accompanying the woman for an antenatal visit, or through the woman herself, as appropriate. Household members will be asked to help the pregnant woman by creating a smoke free car and home, not smoking near her, and by providing encouragement and support. A specific brochure related to this will be provided. Where possible household members will also be encouraged to quit smoking themselves, and if interested will be supported to do so through brief intervention counselling and referral to other local smoking cessation services, including those provided through the ATSICHS and IUIH, with provision of free NRT if appropriate.
8. Post-partum support: For women who quit smoking during their pregnancy and are not smoking at the end of their pregnancy, supportive counselling and follow-up will be provided until 6 months post-partum. Approximately 70% of women who quit smoking during pregnancy experience relapse after the baby is born; support during this period may help prevent this. Visits will be weekly for the first four weeks, then fortnightly until six months postpartum. A brochure focusing on the postpartum period will be given to women in late pregnancy, in order to raise the issues early, as relapse early in the post-partum period is common. This brochure will also be used to guide discussions in the post-partum period.
9. Resources: Four brochures will be used and will emphasise the benefits of quitting, with a focus on short term/immediate gains and benefits to the woman, the baby and the family. These brochures will cover harms from smoking, benefits from quitting, strategies to assist with quitting and to avoid relapse including in social situations, and alternative activities to replace smoking and the benefits from smoking.
10. Contingency-based financial rewards (CBFR): (N.B. We use the term ‘rewards’ rather than ‘incentives’ to recognise and acknowledge the effort women make in quitting smoking). Rewards will be provided for validated abstinence at each visit, according to the following:
a) Validation by expired carbon monoxide (CO). Monitoring using expired CO will take place at each scheduled program visit (twice weekly for two weeks, weekly for four weeks, then fortnightly until the birth) if the woman reports quitting, using MICRO-smokerlyzers (Bedfont Scientific Ltd, Kent UK) and a cut-off CO less than or equal to 6ppm indicating abstinence.
b) Immediate provision of CBFR. Women testing negative for smoking (expired CO equal to or less than 6ppm) will be provided with a reward within, or as close as possible to within, a 48 hour period after the result confirming abstinence. This is consistent with the principle of providing rewards as soon as possible after confirmation of abstinence. The reward will be provided as one of two options: 1) vouchers in the form of Coles Myer gift cards, (cannot be used for purchase of tobacco or alcohol) provided to the woman immediately; or 2) having the value of the reward deposited directly into a pre-nominated bank account.
c. CBFR value. The rewards will be given in conjunction with the follow-up visits described in section 4 above. They will start at $10 and increase by $2 for each consecutive CO-negative test (i.e. confirmed non-smoking) to a maximum of $30. If women test CO-positive (i.e. smoking) the frequency of monitoring and value of the reward voucher will be reset to the beginning and they will not be given a voucher until they again test CO-negative (i.e. non-smoking). If they then test CO-negative for 3 consecutive tests, the frequency and value of the reward voucher will be reinstated to the previous level. These amounts were considered appropriate by the Community Reference Group involved in developing the initial pilot program and the structure is consistent with the principles of setting the value at a level sufficiently high to be attractive and of progressive increase to reinforce abstinence with resetting of rewards following relapse. As an indication of the amount women can receive, the amount for a woman quitting at 12 weeks gestation, and continuing without smoking until 6 months post-partum would total $970. Women booking later than 12 weeks, but still quitting and remaining abstinent, will receive a total which is proportionately lower.
d. Post-partum CBFR. Following the birth of the baby, provision of CBFR will continue until 6 months post-partum, in conjunction with the post-partum support visits, with frequency of visits and rewards initially increasing to weekly to reinforce post-partum abstinence, then gradually becoming less frequent.
Training: A two day training workshop will be delivered to all SST staff (midwives, health and support workers) to enhance their knowledge and skills in the provision of smoking cessation to pregnant women, and the specific procedures for this program. The training will be provided by CI Passey and AIs Turnbull who have extensive experience in smoking cessation training, the use of motivational interviewing and other psychological strategies for managing smoking cessation. Training will include sessions on smoking and pregnancy, addiction, smoking cessation during pregnancy, social and emotional wellbeing, counselling skills, and the use of the resources and procedures involved in delivering the SST program. Training on the use of the Smokerlyzers and cotinine testing will be included. Following the initial training, ongoing supervision and support will be provided through regular meetings, with identification of challenges and gaps in skills. Additional training will be provided as required.

The duration of the program from first booking in visit until 6 months post-partum, should the woman stay in the program for its full duration.

Intervention code [1]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

Treatment: Other

Comparator / control treatment

nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The proportion of participants who self-report abstinence for the previous seven days, validated by salivary cotinine <10ng/ml, using the NicAlert Registered Trademark (Nymox Pharmaceutical Corporation, USA) system

Timepoint [1]

36 weeks pregnancy and six months postpartum

Secondary outcome [1]

The proportion of participants who self-report at least one quit attempt

Timepoint [1]

Assessed at every scheduled visit (according to the intervention schedule above) until 6 months post-partum (n.b. twice weekly for two weeks, then weekly for four weeks, then fortnightly until the baby’s birth; then weekly for four weeks, then fortnightly until 6 months post-partum).

Secondary outcome [2]

Report at least one successful quit lasting greater than 24 hours validated by expired CO less than or equal to 6ppm using a MICRO-Smokerlyzer (Bedfont Scientific Ltd, Kent UK) at one of the scheduled smoking cessation visits

Timepoint [2]

Assessed at every scheduled visit (e.g. twice weekly for two weeks, then weekly for four weeks, then fortnightly until the baby’s birth; then weekly for four weeks, then fortnightly until 6 months post-partum).

Secondary outcome [3]

Proportion of participants who self-report smoking abstinence from six weeks after booking in until 36-38 weeks gestation; validated by salivary cotinine less than or equal to 10ng/ml, (using the NicAlert Registered Trademark system) and a record that all MICRO-Smokerlyzer CO readings taken at the regular smoking cessation program visits between the specified dates indicate non-smoking (i.e. CO less than or equal to 6ppm). This is a composite outcome.

Timepoint [3]

From six weeks after booking in until 36–38 weeks gestation

Secondary outcome [4]

The proportion of participants who report a reduction of at least 50% in the number of cigarettes smoked from pre-pregnancy levels as reported at the booking-in visit and the 36 week survey

Timepoint [4]

36 weeks gestation

Secondary outcome [5]

The proportion of participants who report that other household members have tried to quit

Timepoint [5]

6 months postpartum

Secondary outcome [6]

The proportion of women who are eligible and agree to participate in “Stop Smoking in its Tracks” as indicated by the signed consent form

Timepoint [6]

Baseline

Secondary outcome [7]

The proportion of participants who commit to quit, as indicated by a signed commitment contract

Timepoint [7]

six months post-partum

Secondary outcome [8]

The proportion of participants who accept NRT; measured by acceptance and details of the type and amount of therapy provided recorded at acceptance in study specific record keeping form for each woman

Timepoint [8]

Over the duration of their participation in the study

Secondary outcome [9]

The proportion of participants who indicate that the program and individual components were helpful in managing their quit attempt as assessed by survey at 36 weeks

"Please mark any of the things listed below, that helped you actually managing your quit attempt (even if you didn’t quite get there). Mark as many as you like:
- the discussions and advice from the staff during my booking-in visit
- the information provided in the brochures
- the discussions with the Stop Smoking in its Tracks worker
- the rewards for quitting (money)
- the frequent support from the Stop Smoking in its Tracks worker
- the Commitment Contract that I signed
- the free NRT available to help me
- the support for the other people in my household to quit too
- the free NRT available to help my family
- the smokerlyzer results
- the enthusiasm and commitment of the Stop Smoking in its Tracks worker
- the praise and acknowledgement I got for my efforts
- Nothing helped me"

Timepoint [9]

Survey at 36 weeks gestation

Secondary outcome [10]

Proportion of participants that receive at least 3 program visits in the first two weeks following recruitment; measured by record of each visit and activities undertaken, recorded in study specific record keeping form for each woman

Timepoint [10]

Baseline to first 2 weeks in the study

Secondary outcome [11]

Proportion of participants who are provided counselling on core topics in the first two weeks following recruitment; measured by record at each visit and activities undertaken, recorded in study specific record keeping form for each woman

Timepoint [11]

Baseline to first 2 weeks

Secondary outcome [12]

Proportion of participants who are provided with the three specified brochures within the first two weeks following recruitment; measured by record at each visit and activities undertaken, recorded in study specific record keeping form for each woman

Timepoint [12]

Baseline to first 2 weeks

Secondary outcome [13]

Proportion who receive at least 6 smoking cessation visits antenatally; measured by record at each visit and activities undertaken, recorded in study specific record keeping form for each woman

Timepoint [13]

baseline to birth of baby

Secondary outcome [14]

Among the women who are not smoking at the birth of their baby, the proportion who receive BOTH the postpartum brochure AND at least four postpartum smoking cessation visits; measured by record at each visit and activities undertaken, recorded in study specific record keeping form for each woman

Timepoint [14]

birth to six months postpartum

Secondary outcome [15]

Number of antenatal program visits per participant; measured by record at each visit and activities undertaken, recorded in study specific record keeping form for each woman

Timepoint [15]

From recruitment until the birth of the baby

Secondary outcome [16]

Proportion who say they are smokers but have negative cotinine salivary results (<10ng/ml) at booking in. Smoking is self-reported during booking in visit. Salivary cotinine test at booking in visit. Both are recorded in the study specific record keeping form for each woman.

Timepoint [16]

Baseline

Secondary outcome [17]

Proportion who report abstinence but have positive salivary cotinine greater to or equal to 10ng/ml at 36 weeks gestation . Smoking is self-reported during study visits. Salivary cotinine test at 36 weeks gestation. Both are recorded in the study specific record keeping form for each woman.

Timepoint [17]

36 weeks gestation

Secondary outcome [18]

The proportion of participants who self-report at least one quit attempt lasting >24 hours

Timepoint [18]

Over the duration of their participation in the study

Secondary outcome [19]

The proportion of participants who report that other household members have successfully quit.

Timepoint [19]

6 months postpartum

Secondary outcome [20]

Proportion who report abstinence but have positive salivary cotinine greater or equal to 10ng/ml at six months post-partum. Smoking is self-reported during study visits. Salivary cotinine test at six months post-partum. Both are recorded in the study specific record keeping form for each woman.

Timepoint [20]

six months post-partum

Secondary outcome [21]

Proportion of participants who self-report smoking abstinence from birth of the baby intil six months post-partum; validated by salivary cotinine less than or equal to 10ng/ml, (using the NicAlert Registered Trademark system) and a record that all MICRO-Smokerlyzer CO readings taken at the regular smoking cessation program visits between the specified dates indicate non-smoking (i.e. CO less than or equal to 6ppm). This is a composite outcome.

Timepoint [21]

from the birth of the baby until six months post-partum

Eligibility

Key inclusion criteria

Receiving antenatal care through the BiOC program. Women are eligible for BiOC if they identify as Aboriginal and/or Torres Strait Islander, or are partnered to an Aboriginal and/or Torres Strait Islander person, and/or are having an Aboriginal and/or Torres Strait Islander baby.

Self-reported daily (at least one cigarette per day) smoking during pregnancy, prior to 36 weeks gestation.

Consent to participate.

Minimum age

14 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Women are not eligible to participate if they are:

Unable/unwilling to provide written consent

Baseline salivary cotinine <10ng/ml.

N.B. Although this study is not specifically targeting young women, we are guided by the National Statement in that women will not be excluded on the basis of youth (age<16) alone. The study will also be guided by usual practice employed for clinical procedures whereby the best interests of the young woman, and her capacity to consent, will be assessed on an individual basis. Hence, young women “who are mature enough to understand and consent, and are not vulnerable through immaturity in ways that warrant additional consent from a parent or guardian” (National Statement: 155) will be invited to consent in their own right. Where there is any concern that immaturity renders a young woman vulnerable, she will not be invited to participate.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Within the Birthing in Our Community maternity care program, women will be assessed for eligibility by the Midwife and/or Indigenous Maternal and Infant Health Worker. Women who are smokers and meet the inclusion criteria will be offered participation in the smoking cessation program by the Midwife and/or Indigenous Maternal and Infant Health Worker with an explanation of what is involved and the support available. They will be provided with the information flyer to guide discussion. Women will be encouraged to ask questions about both the smoking cessation program and its evaluation. They will be assured that their participation is voluntary, and that non-participation will not affect their relationship with the BiOC team, or the rest of their maternity care. Those potentially interested will be contacted by a member of the SST team within a few days to ascertain their interest in participating and to provide the SST program if they chose to participate. The staff give the woman the Participant Information and Consent Sheet and will undertake the informed consent process. They will again explain that participation is voluntary and that women may withdraw at any time and will answer any outstanding questions. Those willing to participate will provide written consent.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

no randomisation

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

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

19/10/2015

Date of last participant enrolment

Anticipated

31/12/2018

Actual

12/12/2018

Date of last data collection

Anticipated

30/06/2019

Actual

8/04/2019

Sample size

Target

140

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Mother's Hospital - South Brisbane

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

16 Marcus Clarke St, Canberra City ACT 2600

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

The Mater Health Service (MHS)

Address [2]

Raymond Tce, South Brisbane Qld 4101

Country [2]

Australia

Funding source category [3]

Other Collaborative groups

Name [3]

The Institute for Urban Indigenous Health (IUIH)

Address [3]

23 Edgar Street, Bowen Hills, QLD 4006

Country [3]

Australia

Funding source category [4]

Other Collaborative groups

Name [4]

The Aboriginal and Torres Strait Islander Community Health Service (ATSICHS) Brisbane, Ltd

Address [4]

55 Annerley Rd, Woolloongabba Qld 4102

Country [4]

Australia

Primary sponsor type

Individual

Name

Prof Sue Kildea

Address

Molly Wardaguga Research Centre, CDU
Level 11, East Tower
410 Ann St
Brisbane City QLD 4000

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

A/Prof Megan Passey

Address [1]

University Centre for Rural Health North Coast
The University of Sydney
61 Uralba St, Lismore, NSW 2480

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Prof Sue Kruske

Address [1]

Institute for Urban Indigenous Health
23 Edgar Street, Bowen Hills, QLD 4006

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Anton Clifford

Address [2]

School of Public Health
Faculty of Medicine and Biomedical Sciences
The University of Queensland
Level 2, Public Health Building
Herston Road
Herston QLD 4006

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Carmel Nelson

Address [3]

Institute for Urban Indigenous Health
23 Edgar Street, Bowen Hills, QLD 4006

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Dr Yvette Roe

Address [4]

Mater Medical Research Institute, Aubigny Place, Raymond Tce, South Brisbane Qld 4101

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Health Services Human Research Ethics Committee (MHS HREC)

Ethics committee address [1]

Room 294, Level 2 Aubigny Place
Raymond Tce, South Brisbane, QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/04/2015

Approval date [1]

21/05/2015

Ethics approval number [1]

HREC/15/MHS/37

Ethics committee name [2]

Medical Research Ethics Committee, The University of Queensland

Ethics committee address [2]

The University of Queensland
Cumbrae-Stewart Building
Research Road
St Lucia Qld 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

21/05/2015

Approval date [2]

29/05/2015

Ethics approval number [2]

2015000856

Summary

Brief summary

This research project aims to help 'close the gap' for Aboriginal and Torres Strait Islander mothers and babies by improving health services, in particular smoking cessation programs for pregnant women. Smoking in pregnancy can cause miscarriage, baby born too early (premature), low birth weight for baby (unhealthy baby), breathing problems and sickness for baby, and sudden infant death syndrome (SIDS). Smoking among pregnant Aboriginal and Torres Strait Islander women remains more than three times as common as among non-Indigenous pregnant women, yet there is little evidence of the best way to address this problem.

As part of the Birthing in Our Community maternity care program, we will be implementing a novel smoking cessation program - “Stop Smoking in its Tracks”. The program involves intensive support to help women quit, free nicotine replacement therapy, rewards for confirmed abstinence and continues for six months post-partum. Support will also be offered to household members if they want to quit.

This study will assess how effective the program is, what women think about it, and how easy it is to provide “Stop Smoking in its Tracks”. The study will involve collecting information on the care provided, whether women quit smoking and what other factors might be influencing quit attempts and successful quitting.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Sue Kildea

Address

Molly Wardaguga Research Centre, CDU
Level 11, East Tower
410 Ann St
Brisbane City QLD 4000

Country

Australia

Phone

+61 (7) 3163 6388

Fax

[email protected]

Contact person for public queries

Name

Prof Sue Kildea

Address

Mater Research Institute, University of Queensland (MRI-UQ)
School of Nursing, Midwifery and Social Work, UQ
Women's Health and Newborn Services (Maternity)
Mater Health Service
Level 1, Aubigny Place, South Brisbane, Qld 4101

Country

Australia

Phone

+61 (7) 3163 6388

Fax

[email protected]

Contact person for scientific queries

Name

Prof Sue Kildea

Address

Molly Wardaguga Research Centre, CDU
Level 11, East Tower
410 Ann St
Brisbane City QLD 4000

Country

Australia

Phone

+61 7 3169 4278

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Plain language summary	No		Not yet

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No additional documents have been identified.

Trial Review

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