Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000929202
Ethics application status
Approved
Date submitted
27/10/2009
Date registered
28/10/2009
Date last updated
28/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of a high intensity smoking intervention for pregnant Indigenous women
Scientific title
The effect of a multifaceted high intensity culturally specific intervention incorporating advice, support and nicotine replacement on smoking cessation rates in pregnant Indigneous women: a randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking in pregnancy 252066 0
Condition category
Condition code
Reproductive Health and Childbirth 252267 252267 0 0
Other reproductive health and childbirth disorders
Mental Health 252281 252281 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A multifaceted tailored intervention including culturally specific advice and support for Indigenous participants, evidence based communication and nicotine replacement after 2 failed quit attempts. From the time the woman engages in an active quit attempt she is seen again in the clinic at a minimum of 2 visits within 5 and 14 days of the visit at which she agrees to attempt to quit smoking with support and advice. If after two visits with support and advice she is still a smoker trying to quit with no contrainications to nicotine replacement therapy and she is prescribed nicotine gum. For smokers of less than 25 cigarettes per day the 2mg gum is prescribed as required up to 24 times per day and for smokers of more than 25 cigarettes per day the 4 mg gum is prescribed. The gum is prescribed as needed for up to 12 weeks.
Intervention code [1] 241460 0
Behaviour
Intervention code [2] 241468 0
Prevention
Intervention code [3] 241469 0
Lifestyle
Comparator / control treatment
Usual clinical care with brief General Pracitioner (GP) and clinic health care provider quit advice
Control group
Active

Outcomes
Primary outcome [1] 253137 0
Self report and continine validated smoking cessation
Timepoint [1] 253137 0
Assessed at an antenatal visit occuring between 36-40 weeks gestation and at 6 months postpartum
Secondary outcome [1] 262018 0
Mean birth weight and gestational age as recorded on the hospital discharge form.
Timepoint [1] 262018 0
At birth

Eligibility
Key inclusion criteria
Pregnant and attending for antenatal care before 20 weeks gestation
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
major mental illness or chemical dependency other than tobacco or alcohol

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)
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
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2168 0
6000

Funding & Sponsors
Funding source category [1] 243929 0
Government body
Name [1] 243929 0
National Health and Medical Research Council
Country [1] 243929 0
Australia
Primary sponsor type
Individual
Name
Professor Sandra Eades
Address
Baker IDI Heart and Diabetes Institute
75 Commercial Rd
Melbourne
Vic 3004
Country
Australia
Secondary sponsor category [1] 251286 0
Individual
Name [1] 251286 0
Professor Rob Sanson Fisher
Address [1] 251286 0
Discipline of Health Behaviour Sciences
Center for Clinical Epidemiology and Biostatistics
Level 3
David Maddison Building
University of Newcastle
Watts St Newcastle NSW 2308
Country [1] 251286 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244040 0
University of Newcastle Human Ethics Committee
Ethics committee address [1] 244040 0
Ethics committee country [1] 244040 0
Date submitted for ethics approval [1] 244040 0
30/03/2005
Approval date [1] 244040 0
25/07/2005
Ethics approval number [1] 244040 0
H-068-0705 and H-067-0705

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

Contacts
Principal investigator
Name 30423 0
Address 30423 0
Country 30423 0
Phone 30423 0
Fax 30423 0
Email 30423 0
Contact person for public queries
Name 13670 0
Professor Sandra Eades
Address 13670 0
Baker IDI Heart and Diabetes Institute
75 Commercial Rd Melbourne Victoria 3004
Country 13670 0
Australia
Phone 13670 0
+61385321535
Fax 13670 0
+61385321100
Email 13670 0
[email protected]
Contact person for scientific queries
Name 4598 0
Sandra Eades
Address 4598 0
Baker IDI Heart and Diabetes Institute
75 Commercial Rd Melbourne Victoria 3004
Country 4598 0
Australia
Phone 4598 0
+61385321535
Fax 4598 0
+61385321100
Email 4598 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
SourceTitleYear of PublicationDOI
Dimensions AIAn intensive smoking intervention for pregnant Aboriginal and Torres Strait Islander women: a randomised controlled trial2012https://doi.org/10.5694/mja11.10858
N.B. These documents automatically identified may not have been verified by the study sponsor.