Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000520639
Ethics application status
Approved
Date submitted
10/05/2014
Date registered
15/05/2014
Date last updated
10/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incentives to stop smoking among pregnant Maori women:
A feasibility trial
Scientific title
In pregnant Maori women who smoke, do Incentives to stop smoking, compared to usual care, increase smoking cessation?
Secondary ID [1] 284574 0
Nil
Universal Trial Number (UTN)
U1111-1156-6602
Trial acronym
Awhi-Incentives
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventing smoking related illness 291863 0
Smoking during pregnancy 291900 0
Condition category
Condition code
Public Health 292213 292213 0 0
Health promotion/education
Reproductive Health and Childbirth 292245 292245 0 0
Antenatal care
Mental Health 292246 292246 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2)usual care plus a retail voucher to the value of NZ$25 for each ‘abstinent from smoking’ week for eight weeks (voucher), or 3) usual care plus product, selected from a catalogue, to the value of NZ$25 for each ‘abstinent from smoking’ week for eight weeks (product). Abstinence from smoking was assessed through weekly self-reports in conjunction with biochemical validation (carbon monoxide) conducted once per week at random times and days
Intervention code [1] 289351 0
Prevention
Intervention code [2] 289376 0
Behaviour
Comparator / control treatment
For the 1) control condition participants were provided with cessation support, including information about different cessation products and service. Cessation support was provided by the research assistant at face-to-face meetings as well as telephone support during each weekly contact. Duration of each contact will be as long as required by each participant, on average a few minutes for the phone contacts and 15-30minutes for face-to-face contacts.
Control group
Active

Outcomes
Primary outcome [1] 292084 0
Biochemical validation, using carbon monoxide (CO), of abstinence from smoking
Timepoint [1] 292084 0
Monthly from baseline until end of trial (8 weeks)
Secondary outcome [1] 308181 0
Weekly self-reported smoking status, assessed via telephone call or short message
Timepoint [1] 308181 0
Weekly from baseline until end of trial (8 weeks)
Secondary outcome [2] 308182 0
Log kept of time for the research assistant to contact and visit participants
Timepoint [2] 308182 0
weekly, from baseline until end of trial (8 weeks)

Eligibility
Key inclusion criteria
self-identified as Maori, resided in the Auckland region, were 2-30 weeks pregnant, and were daily smokers
Minimum age
16 Years
Maximum age
100 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women were excluded if they were no longer smoking daily or if they were participating in any other smoking cessation trials.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Immediately after baseline data had been recorded, participants were randomised in a 1:1 ratio to one of three arms using envelope randomisation prepared by a statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data were entered and analysed using Microsoft Excel Spreadsheet and simple descriptive statistics were 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. Participants were considered to be smokers if they reported smoking during the previous week or if they had a CO measure greater than or equal to 7ppm for one or more months. Drop-outs were assumed to have relapsed back to smoking.

No sample size was calculated for this study given it was a pilot study that aimed to determine the likely effect size to help power a larger trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2012
Actual
11/01/2013
Date of last participant enrolment
Anticipated
30/06/2013
Actual
30/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 6044 0
New Zealand
State/province [1] 6044 0
Auckland

Funding & Sponsors
Funding source category [1] 289207 0
Government body
Name [1] 289207 0
Ministry of Health
Country [1] 289207 0
New Zealand
Primary sponsor type
Individual
Name
Marewa Glover
Address
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 287883 0
Individual
Name [1] 287883 0
Anette Kira
Address [1] 287883 0
University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 287883 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290981 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 290981 0
Ethics committee country [1] 290981 0
New Zealand
Date submitted for ethics approval [1] 290981 0
Approval date [1] 290981 0
01/07/2012
Ethics approval number [1] 290981 0
(12/NTB/32/AM02)

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

Contacts
Principal investigator
Name 48254 0
Dr Marewa Glover
Address 48254 0
University of Auckland
Private Bag 92019
Auckland 1142
Country 48254 0
New Zealand
Phone 48254 0
64 9 373 7599 x 86044
Fax 48254 0
Email 48254 0
[email protected]
Contact person for public queries
Name 48255 0
Marewa Glover
Address 48255 0
University of Auckland
Private Bag 92019
Auckland 1142
Country 48255 0
New Zealand
Phone 48255 0
64 9 373 7599 x 86044
Fax 48255 0
Email 48255 0
[email protected]
Contact person for scientific queries
Name 48256 0
Marewa Glover
Address 48256 0
University of Auckland
Private Bag 92019
Auckland 1142
Country 48256 0
New Zealand
Phone 48256 0
64 9 373 7599 x 86044
Fax 48256 0
Email 48256 0
[email protected]

No information has been provided regarding IPD availability


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.