Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000591954
Ethics application status
Approved
Date submitted
8/09/2009
Date registered
8/06/2011
Date last updated
29/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Keeping Kids Smokefree - an intervention aimed at changing parents smoking behaviour and attitudes in order to reduce uptake of smoking by their intermediate school aged children.
Scientific title
Keeping Kids Smokefree: A quasi-experimental community trial to reduce smoking uptake among Maori, Pacific and lower socioeconomic children in South Auckland by working with their parents and schools.
Secondary ID [1] 262334 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of smoking uptake among pre-adolescents. 243688 0
Condition category
Condition code
Public Health 239956 239956 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions are to be provided over a period of 3 years. Controlled Purchase Operations and visits to retailers to reduce sales of tobacco to minors will be repeated at 6 monthly intervals for the 3 years. Stop smoking quit attempts among parents, teachers and adults in the community will be prompted by invitations to make use of free quit coaching services and subsidised NRT products. An educational DVD for parents about how to prevent their children from taking up smoking will be sent home with every student for free viewing at home. Health promotion events at school for teachers, students and their families will be run once a year to inform parents about stopping smoking and other health services in their community, and to consolidate the relationship between parents, school and the research team. A voluntary art competition for students will be run each year to engage students in thinking about smokefree messages and to generate artwork for promotion of the project within the community. Feedback from each of the interventions will be sought in an evaluation sheet sent to parents at the end of each year.
Intervention code [1] 241233 0
Prevention
Comparator / control treatment
An active control consisting of a matched community and schools were also surveyed, but received no intervention.
Control group
Active

Outcomes
Primary outcome [1] 240760 0
Smoking prevalence among students at follow-up. Smoking prevalence will be assessed by NicAlert saliva testing of all consented students plus questionnaires completed by both students and parents.
Timepoint [1] 240760 0
Follow-up Year 2 will take place in November during term 4 after the intervention activities for that school year have been completed. Similarly follow-up Year 3 will take place in November during term 4 of Year 3.
Secondary outcome [1] 257430 0
Perceived ease with which students can purchase tobacco. This outcome will be assessed through a questionnaire administered to the students on a personal digital assistant device. Students will be asked where and how often they access tobacco.
Timepoint [1] 257430 0
Follow-up Year 2 will take place at the end of year 2 after the intervention activities have been completed. Follow-up Year 3 will take place at the end of year 3 after the intervention activities have been completed.

Eligibility
Key inclusion criteria
All students and their parents/caregivers of participating Intermediate Schools (middle schools providing Yr 7 and Yr 8 education, ages typically 11 and 12); where parent consent is obtained.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parent declined.

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)
Two schools were recruited as intervention schools and two matched schools were recruited as the comparator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The schools were not randomised.
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
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3900
Accrual to date
Final
Recruitment outside Australia
Country [1] 2038 0
New Zealand
State/province [1] 2038 0

Funding & Sponsors
Funding source category [1] 243610 0
Government body
Name [1] 243610 0
Health Research Council of New Zealand
Country [1] 243610 0
New Zealand
Primary sponsor type
University
Name
Auckland Uniservices Ltd
Address
Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 237059 0
University
Name [1] 237059 0
Centre for Tobacco Control Research, University of Auckland
Address [1] 237059 0
University of Auckland School of Population Health, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country [1] 237059 0
New Zealand
Other collaborator category [1] 842 0
University
Name [1] 842 0
Clinical Trials Research Unit, University of Auckland
Address [1] 842 0
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 842 0
New Zealand
Other collaborator category [2] 843 0
Charities/Societies/Foundations
Name [2] 843 0
Action on Smoking and Health (ASH NZ)
Address [2] 843 0
19 Mauranui Avenue, Epsom, Auckland
PO Box 99126 Newmarket, Auckland 1149
Country [2] 843 0
New Zealand
Other collaborator category [3] 844 0
Hospital
Name [3] 844 0
Auckland Regional Public Health Service
Address [3] 844 0
Auckland Regional Public Health Service
Level 2, 3 and 4 Building 15, Cornwall Complex, Green Lane Clinical Centre, Claude Road, Epsom, Auckland 1023

Private Bag 92605
Symonds Street
Auckland 1150
Country [3] 844 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243735 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 243735 0
Ethics committee country [1] 243735 0
New Zealand
Date submitted for ethics approval [1] 243735 0
Approval date [1] 243735 0
13/12/2006
Ethics approval number [1] 243735 0
2006/416

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

Contacts
Principal investigator
Name 30160 0
Address 30160 0
Country 30160 0
Phone 30160 0
Fax 30160 0
Email 30160 0
Contact person for public queries
Name 13407 0
Dr Marewa Glover
Address 13407 0
Director
Centre for Tobacco Control Research
Social & Community Health
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
Country 13407 0
New Zealand
Phone 13407 0
+6493737599 extn 86044
Fax 13407 0
+6493035932
Email 13407 0
[email protected]
Contact person for scientific queries
Name 4335 0
Dr Marewa Glover
Address 4335 0
Director
Centre for Tobacco Control Research
Social & Community Health
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142
Country 4335 0
New Zealand
Phone 4335 0
+6493737599 extn 86044
Fax 4335 0
+6493035932
Email 4335 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.