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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
Scientific title
Extending Breastfeeding Duration by Preventing Relapse to Smoking among Post-Natal Maori Women: Introducing Vaping Feasibility Study
Secondary ID [1] 297365 0
Nil
Universal Trial Number (UTN)
U1111-1228-3021
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast feeding 311497 0
Smoking Relapse Prevention 311498 0
Condition category
Condition code
Reproductive Health and Childbirth 310131 310131 0 0
Breast feeding
Public Health 310132 310132 0 0
Health promotion/education
Mental Health 310211 310211 0 0
Addiction

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313614 0
Lifestyle
Intervention code [2] 313615 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319025 0
Feasibility of intervention as assessed by number enrolled in the study.
Timepoint [1] 319025 0
At end of 6 month trial.
Primary outcome [2] 319026 0
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.
Timepoint [2] 319026 0
8 weeks post-partum or post-enrolment if the mother has already given birth at the time of enrolment.
Secondary outcome [1] 366752 0
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.
Timepoint [1] 366752 0
At 2-8 weeks.
Secondary outcome [2] 366969 0
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.
Timepoint [2] 366969 0
Weekly and at final 8 week follow-up.

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.
Minimum age
16 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
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.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/03/2019
Actual
Date of last participant enrolment
Anticipated
12/04/2019
Actual
Date of last data collection
Anticipated
7/06/2019
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 21275 0
New Zealand
State/province [1] 21275 0

Funding & Sponsors
Funding source category [1] 301926 0
Charities/Societies/Foundations
Name [1] 301926 0
Foundation for a Smoke-Free World
Country [1] 301926 0
United States of America
Primary sponsor type
Other
Name
Centre of Research Excellence: Indigenous Sovereignty & Smoking
Address
PO Box 89186
Torbay
Auckland 0742
New Zealand
Country
New Zealand
Secondary sponsor category [1] 301684 0
None
Name [1] 301684 0
Address [1] 301684 0
Country [1] 301684 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302612 0
Health & Disability Ethics Committee
Ethics committee address [1] 302612 0
Ethics committee country [1] 302612 0
New Zealand
Date submitted for ethics approval [1] 302612 0
22/02/2019
Approval date [1] 302612 0
Ethics approval number [1] 302612 0

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

Contacts
Principal investigator
Name 90818 0
Prof Marewa Glover
Address 90818 0
Centre of Research Excellence: Indigenous Sovereignty & Smoking
PO Box 89186
Torbay
Auckland 0742
Country 90818 0
New Zealand
Phone 90818 0
+64 27 2757852
Fax 90818 0
Email 90818 0
m.glover@coreiss.com
Contact person for public queries
Name 90819 0
Marewa Glover
Address 90819 0
Centre of Research Excellence: Indigenous Sovereignty & Smoking
PO Box 89186
Torbay
Auckland 0742
Country 90819 0
New Zealand
Phone 90819 0
+64 27 2757852
Fax 90819 0
Email 90819 0
m.glover@coreiss.com
Contact person for scientific queries
Name 90820 0
Marewa Glover
Address 90820 0
Centre of Research Excellence: Indigenous Sovereignty & Smoking
PO Box 89186
Torbay
Auckland 0742
Country 90820 0
New Zealand
Phone 90820 0
+64 27 2757852
Fax 90820 0
Email 90820 0
m.glover@coreiss.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
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.
Available to whom?
Anyone who wishes to access it who provides registration details on the website.
Available for what types of analyses?
None specified.
How or where can data be obtained?
A ftp link will be provided in the results publication.


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.