Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000854730
Ethics application status
Approved
Date submitted
30/07/2013
Date registered
2/08/2013
Date last updated
2/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
TALANOA Samoa: A randomised controlled trial to evaluate the efficacy of a cessation support programme for smokers delivered via radio.
Scientific title
TALANOA Samoa: A randomised controlled trial in Auckland involving Samoan smokers of tobacco that listen to quit smoking advice delivered over the Radio with the aim of reducing smoking prevalence.
Secondary ID [1] 282921 0
Nil
Universal Trial Number (UTN)
U1111-1139-8316
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advice on how to quit smoking cigarettes and treatments available to aid quitting. 289735 0
Condition category
Condition code
Public Health 290065 290065 0 0
Health promotion/education
Mental Health 290103 290103 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves 10 weekly (half-hour) programmes broadcast over the radio as we have 10 topics to get through. There will be one new program a week with a repeat later that same week as well as a podcast of the program available if participants have missed the program. The weekly programs are: 1. Preparing to quit; 2. Advice on stop smoking treatments (e.g. NRT patches, gum, lozenges; mouthspray, Champix, National Quitline, E-cigarettes) ; 3. Provide information of withdrawal symptoms; 4. How to cope after quitting; 5. Explain Carbon monoxide monitoring; 6. Talkback session; 7. Strengthen ex-smoker identity; 8. Talkback 9. Talkback; 10. Talkback

Participants in the intervention group will have a Workbook where they will record whether they have listened to the programs.
Intervention code [1] 287620 0
Treatment: Other
Intervention code [2] 287646 0
Behaviour
Comparator / control treatment
The control group of smokers will not be required to do anything. Some of them are likely to quit smoking "cold turkey" and this unassisted quit rate will be our control quit rate to compare with the intervention rate.
Control group
Active

Outcomes
Primary outcome [1] 290117 0
Prevalence of those stopping smoking. 'Stopping smoking' is defined as not having smoked a cigarette (even a puff) within the last 7 days. This will be self reported using a participant questionnaire and verified using exhaled carbon monoxide (CO) testing, with <10 ppm considered not smoking.
Timepoint [1] 290117 0
3 months follow-up.
Secondary outcome [1] 303969 0
Number of attempts to quit smoking (successful or unsuccessful). this will be self-reported using a participant questionnaire.
Timepoint [1] 303969 0
At 3 months follow-up.

Eligibility
Key inclusion criteria
Must be a smoker of tobacco
Understand the Samoan language
Must be aged 16 years or over
Be an Auckland resident
Consent to take part in the study
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Can only have one member per family household in the study, in case one gets the intervention and the other control, which would cause contamination.

Study design
Purpose of the study
Educational / counselling / training
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment outside Australia
Country [1] 5253 0
New Zealand
State/province [1] 5253 0
Auckland

Funding & Sponsors
Funding source category [1] 287698 0
Government body
Name [1] 287698 0
Health Research Council
Country [1] 287698 0
New Zealand
Funding source category [2] 287699 0
Government body
Name [2] 287699 0
Ministry of Health
Country [2] 287699 0
New Zealand
Primary sponsor type
University
Name
Tobacco Control Research Turanga (University of Auckland)
Address
Tobacco Control Research Turanga
School of Population Health,
University of Auckland,
Level 3, Building 730, Tamaki Campus,
261 Morrin Rd, Glen Innes, Auckland

Postal address: Tobacco Control Research Turanga
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286431 0
University
Name [1] 286431 0
National Institute for Health Innovation (University of Auckland)
Address [1] 286431 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
NEW ZEALAND
Country [1] 286431 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289659 0
Health and Disability Ethics Committees
Ethics committee address [1] 289659 0
Ethics committee country [1] 289659 0
New Zealand
Date submitted for ethics approval [1] 289659 0
Approval date [1] 289659 0
26/07/2013
Ethics approval number [1] 289659 0
13/STH/75

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

Contacts
Principal investigator
Name 41818 0
Dr Vili Nosa
Address 41818 0
Pacific Health
University of Auckland
School of Population Health- Tamaki Campus
Building 730, Main Entrance, 261 Morrin Road, Glen Innes
Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 41818 0
New Zealand
Phone 41818 0
+64-9-373-7599
Fax 41818 0
+64-9-303-5932
Email 41818 0
v.nosa@auckland.ac.nz
Contact person for public queries
Name 41819 0
Marewa Glover
Address 41819 0
Centre for Tobacco Research
University of Auckland
School of Population Health- Tamaki Campus
Building 730, Main Entrance, 261 Morrin Road, Glen Innes
Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 41819 0
New Zealand
Phone 41819 0
+64-9-373-7599
Fax 41819 0
+64-9-303-5932
Email 41819 0
m.glover@auckland.ac.nz
Contact person for scientific queries
Name 41820 0
Dudley G R Gentles
Address 41820 0
Centre for Tobacco Research
University of Auckland
School of Population Health- Tamaki Campus
Building 730, Main Entrance, 261 Morrin Road, Glen Innes
Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 41820 0
New Zealand
Phone 41820 0
+64-9-373-7599
Fax 41820 0
+64-9-303-5932
Email 41820 0
d.gentles@auckland.ac.nz

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.