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Trial registered on ANZCTR
Registration number
ACTRN12619000249156p
Ethics application status
Not yet submitted
Date submitted
11/02/2019
Date registered
19/02/2019
Date last updated
19/02/2019
Date data sharing statement initially provided
19/02/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Preventing relapse to smoking to extend duration of breastfeeding
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Scientific title
Extending Breastfeeding Duration by Preventing Relapse to Smoking among Post-Natal Maori Women: Introducing Vaping Feasibility Study
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Secondary ID [1]
297365
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Nil
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Universal Trial Number (UTN)
U1111-1228-3021
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast feeding
311497
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Smoking Relapse Prevention
311498
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Condition category
Condition code
Reproductive Health and Childbirth
310131
310131
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0
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Breast feeding
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Public Health
310132
310132
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0
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Health promotion/education
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Mental Health
310211
310211
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A research assistant will advise women that it is best to abstain from smoking altogether while breastfeeding. Postnatal Maori women at high risk of relapsing to smoking will be provided with a lockable storage container including a vaping starter kit containing 2 vaporisers, zero nicotine e-liquid and a 6 or 12mg nicotine e-liquid of a flavour they can choose from a limited range selected. The women will be advised that if they experience strong urges to smoke that they cannot withstand, they should use a vaporiser ad libitum as required instead of smoking. The duration of the trial is 8 weeks. Trained research assistants will be deliver the intervention. The research assistant will contact each participant weekly by phone, text, email, or in-person (through weeks 2-7; and in-person at week 8) to ask follow-up questions about current smoking or vaping status, current breastfeeding practice and challenges to continuing to breastfeed. Exhaled carbon monoxide readings will be taken at baseline, and in-person follow-up interviews.
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Intervention code [1]
313614
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Lifestyle
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Intervention code [2]
313615
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility of intervention as assessed by number enrolled in the study.
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Assessment method [1]
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Timepoint [1]
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At end of 6 month trial.
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Primary outcome [2]
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Acceptability will be assessed in an in-person interview at the end of the 8 week intervention. Qualitative questions will be asked about perceived acceptability of vaping as an alternative to relapsing to smoking amongst post-natal women who initiate breastfeeding and willingness to recommend the intervention to others if it was available.
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Assessment method [2]
319026
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Timepoint [2]
319026
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8 weeks post-partum or post-enrolment if the mother has already given birth at the time of enrolment.
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Secondary outcome [1]
366752
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Feasibility of choosing vaping as an alternative to relapse to smoking. This will be evaluated by analysing the rates of relapse to smoking versus initiation of vaping or maintenance of abstinence. Interview questions (designed specifically for this study) administered by a research assistant at weeks 2-8 will be used to collect self-reported smoking status and vaping status. At week 8 an exhaled carbon monoxide reading will be taken using a PicoSmokelyser.
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Assessment method [1]
366752
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Timepoint [1]
366752
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At 2-8 weeks.
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Secondary outcome [2]
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Feasibility of extending breastfeeding will be assessed using duration of breastfeeding rates and qualitative questions about reasons for ceasing breastfeeding. Interview questions (designed specifically for this study) administered by a research assistant at weeks 2-8 will be used to collect self-reported breastfeeding status.
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Assessment method [2]
366969
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Timepoint [2]
366969
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Weekly and at final 8 week follow-up.
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Eligibility
Key inclusion criteria
Participants will be eligible if they self-identify as Maori women, are aged 16 or over and have smoked prior to or during pregnancy but have quit prior to the birth of their infant/s. They must be intending to breastfeed and have no identified impediments to breastfeeding. All participants must be able to speak English and able to give consent on their own behalf.
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Minimum age
16
Years
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Maximum age
55
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Women under age 16, who do not self-identify as Maori, and who have not recently been pregnant and women who do not initiate breastfeeding will be excluded. Women who record an exhaled carbon monoxide reading of greater than 6ppm (indicating current smoking) will be excluded. Women who smoke cannabis or who intend to smoke cannabis during the period of the trial will be excluded. Smoking cannabis similarly increases CO in exhaled breath contaminating the detection of current tobacco smoking. Women who are using NRT will be excluded as they are less at risk of relapsing to smoking. Current use of NRT would confound the need for vaping.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Data will be entered and analysed using Microsoft Excel Spreadsheet and simple descriptive statistics will be produced, with means and standard deviations presented for normally distributed continuous data and medium and inter quartile ranges (IQR) presented for non-normally distributed continuous data, and simple proportions reported for dichotomous outcomes. Drop-outs will be assumed to have relapsed back to smoking.
Qualitative data will be entered into Microsoft Word and analysed using inductive coding and categorising to identify themes.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
18/03/2019
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Actual
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Date of last participant enrolment
Anticipated
12/04/2019
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Actual
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Date of last data collection
Anticipated
7/06/2019
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21275
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New Zealand
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State/province [1]
21275
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Funding & Sponsors
Funding source category [1]
301926
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Charities/Societies/Foundations
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Name [1]
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Foundation for a Smoke-Free World
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Address [1]
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575 Fifth Avenue, 14th Floor
New York NY 10017
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Country [1]
301926
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United States of America
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Primary sponsor type
Other
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Name
Centre of Research Excellence: Indigenous Sovereignty & Smoking
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Address
PO Box 89186
Torbay
Auckland 0742
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
301684
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None
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Name [1]
301684
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Address [1]
301684
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Country [1]
301684
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
302612
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Health & Disability Ethics Committee
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Ethics committee address [1]
302612
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
302612
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New Zealand
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Date submitted for ethics approval [1]
302612
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22/02/2019
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Approval date [1]
302612
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Ethics approval number [1]
302612
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Summary
Brief summary
Maori women have the highest smoking rates in New Zealand and the lowest rates for initiating breastfeeding. They also terminate breastfeeding earlier than other ethnic groups. Intent to return to smoking postnatally has been identified as a key reason for not initiating breastfeeding and relapse to smoking has been cited as a reason for stopping breastfeeding prematurely. In this study community health workers will provide advice aimed at extending the average duration of breastfeeding. They will encourage participants to abstain from smoking, but will provide a vape kit for the women to have if they cannot resist the urge to start smoking again. Participants will be advised to stay smokefree and to not vape for as long as possible. They will be advised to breastfeed for as long as they can according to WHO recommendations, even if they vape or relapse to smoking. The women will be surveyed at baseline and weekly for 8 weeks to assess their breastfeeding, smoking or vaping status and to provide support to continue breastfeeding. At the final interview they will be asked about the acceptability of the intervention.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
90818
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Prof Marewa Glover
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Address
90818
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Centre of Research Excellence: Indigenous Sovereignty & Smoking
PO Box 89186
Torbay
Auckland 0742
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Country
90818
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New Zealand
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Phone
90818
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+64 27 2757852
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Fax
90818
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Email
90818
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[email protected]
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Contact person for public queries
Name
90819
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Prof Marewa Glover
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Address
90819
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Centre of Research Excellence: Indigenous Sovereignty & Smoking
PO Box 89186
Torbay
Auckland 0742
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Country
90819
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New Zealand
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Phone
90819
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+64 27 2757852
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Fax
90819
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Email
90819
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[email protected]
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Contact person for scientific queries
Name
90820
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Prof Marewa Glover
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Address
90820
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Centre of Research Excellence: Indigenous Sovereignty & Smoking
PO Box 89186
Torbay
Auckland 0742
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Country
90820
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New Zealand
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Phone
90820
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+64 27 2757852
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Fax
90820
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Email
90820
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The raw de-identified demographic and results data will be available in the form of an Excel sheet.
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When will data be available (start and end dates)?
Immediately following publication of the results paper expected to occur within 1 year of the study end date, approximately 1 May 2020. The data will remain available until 31 May 2024.
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Available to whom?
Anyone who wishes to access it who provides registration details on the website.
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Available for what types of analyses?
None specified.
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How or where can data be obtained?
A ftp link will be provided in the results publication.
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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