ANZCTR - Registration

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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]

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.

Condition category

Condition code

Public Health

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]

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]

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]

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]

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]

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Level 3, 111 Stanley Street
Auckland 1141
New Zealand

Country [1]

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]

University

Name [1]

Centre for Tobacco Control Research, University of Auckland

Address [1]

University of Auckland School of Population Health, Private Bag 92019, Auckland Mail Centre, Auckland 1142

Country [1]

New Zealand

Other collaborator category [1]

University

Name [1]

Clinical Trials Research Unit, University of Auckland

Address [1]

School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142

Country [1]

New Zealand

Other collaborator category [2]

Charities/Societies/Foundations

Name [2]

Action on Smoking and Health (ASH NZ)

Address [2]

19 Mauranui Avenue, Epsom, Auckland
PO Box 99126 Newmarket, Auckland 1149

Country [2]

New Zealand

Other collaborator category [3]

Hospital

Name [3]

Auckland Regional Public Health Service

Address [3]

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]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Auckland Human Participants Ethics Committee

Ethics committee address [1]

The University of Auckland
Office of the Vice Chancellor
Private Bag 92019
Auckland 1142

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

13/12/2006

Ethics approval number [1]

2006/416

Summary

Brief summary

Keeping Kids Smokefree aims to reduce smoking uptake among pre-adolescents living in an urban lower socioeconomic community in South Auckland, New Zealand. Keeping Kids Smokefree works with parents and teachers to encourage them to stop smoking, have smokefree homes and cars so they can reduce the chance their children will take up smoking. Local retailers who sell tobacco are visited and checks are done to ensure they do not sell cigarettes to minors.

Trial website

www.keepingkidssmokefree.org.nz

Trial related presentations / publications

Glover M, Scragg R, Nosa V, McCool J, Bullen C, Min S, Kira A.  Driving kids to smoke? Children’s reported exposure to smoke in cars and early smoking initiation.  Addictive Behaviours 2010; [submitted]
PERAWITI, A., GLOVER, M., LOTO, R., NOSA, V., ERICK-PELETI, S., BULLEN, C., SCRAGG, R., McCOOL, J. ‘Prompting quit attempts using competitions at a community level.’ Towards a Smokefree Aotearoa: Helping smokers quit. National Tobacco Control Hui. Wellington, 25-27 June 2008.
GLOVER, M., TAMATI-ELIFFE, J., WILSON, L., YOUDAN, B., ERICK-PELETI, S., LOTO, R., PERAWITI, A. NOSA, V., McCOOL, J., SCRAGG, R., BULLEN, C. ‘Prompting Maori and Pacific parents to quit using multimedia resources: A DVD and Website.’ Towards a Smokefree Aotearoa: Helping smokers quit. National Tobacco Control Hui. Wellington, 25-27 June 2008.
GLOVER, M., MIN, S., BULLEN, C., SCRAGG, R. ‘Cessation treatments and services: South Auckland parents’ perspectives of what works. Towards a Smokefree Aotearoa: Helping smokers quit. National Tobacco Control Hui. Wellington, 25-27 June 2008
GLOVER M, MIN S, BULLEN C, SCRAGG R. Use of NicAlertTM to measure smoking status and smoke exposure in a pre-adolescent school population. 2009 Joint Conference of the Society for Research on Nicotine and Tobacco and Society for Research on Nicotine and Tobacco-Europe. Dublin, Ireland. 27-30 April 2009. (Poster)
GLOVER, M., MIN, S., BULLEN, C., SCRAGG, R., NOSA, V., MCCOOL, J., EASON C. Smoking is rank! But, not as rank as other drugs and bullying say New Zealand parents of pre-adolescent children. The 14th World Conference on Tobacco or Health, Mumbai, India, 8-12 March 2009. 
WONG, G., GLOVER, M., MIN, S., KOZIOL-MCLAIN, J. Poster: Smoking prevalence, practices and beliefs among Asian school children and their parents in community based intervention study in New Zealand: Baseline results. The 14th World Conference on Tobacco or Health, Mumbai, India, 8-12 March 2009. 
GLOVER, MP, ERICK-PELETI, S., NOSA, V., BULLEN, C., LOTO, R., PAYNTER, J., SCRAGG, R. Does Colour Make a Difference? Maori and Pacific Island parents’ response to and completion of colour vs. black & white questionnaires. Wellbeing: Individual, Organisational, Community. Hauora: Ritenga, Ia Tangata, Iwi Whanui. The Annual Conference of The New Zealand Psychological Society, Christchurch, 29-31 August 2008.  
NOSA V, GLOVER M, MIN S, SCRAGG R, BULLEN C. The rise of the rollie in New Zealand: insights from an ethnically diverse urban population of parents. 2009 Joint Conference of the Society for Research on Nicotine and Tobacco and Society for Research on Nicotine and Tobacco-Europe. Dublin, Ireland. 27-30 April 2009. (Poster)
COWIE, N., GLOVER M, SCRAGG R., BULLEN C. Knowledge of effectiveness of cessation treatments and services among South Auckland parents. Oceania Tobacco Control 09: Reducing inequality through tobacco control. Darwin, Australia. 7-9 October 2009.
CHARLIER, N., GLOVER, M., ROBERTSON, J. Keeping Kids Smokefree: lessons learned on community participation. Health Education Research. Advance Access published on September 9, 2009, doi: 10.1093/her/cyp047.
GLOVER, M.P., COWIE, N. ‘Increasing delivery of smoking cessation treatments to Maori and Pacific smokers.’ N Z Med J 2010;123(1308): 6-8
GLOVER, M.P., SCRAGG, R., NOSA, V., MCCOOL, J., KIRA, A. Keeping Kids Smokefree: Rationale, design and implementation of a community, school, and family-based intervention to modify behaviors related to smoking among Maori and Pacific Island children in New Zealand. International Quarterly of Community Health Education. Submitted 15 December 2009. In press
GLOVER, M.P., KIRA, A., MIN, S., SCRAGG, R., NOSA, V., MCCOOL, J., BULLEN, C.  ‘Smoking is rank! But, not as rank as other drugs and bullying say New Zealand parents of pre-adolescent children.’ Health Promotion Journal of Australia. Submitted 14 May 2010.
GLOVER, M., SCRAGG, R., MIN, S., KIRA, A., NOSA, V., MCCOOL, J., BULLEN, C. Driving kids to smoke? Children’s reported exposure to smoke in cars and early smoking initiation. Addictive Behaviours. Submitted 28 April 2010
CLAYTON-BRAY, L., GLOVER, M. 2010.  Evaluation of health education resources for parents.  Summer Studentship Report.
GLOVER, MP, BULLEN, C., NOSA, V., ERICK-PELETI, S., SCRAGG, R., PAYNTER, J. Does Colour Make a Difference? Maori and Pacific Island parental response to and completion of colour vs. black and white questionnaires, pp 12. Australasian Journal of Market and Social Research 17(2), 2009.
NOSA, V., GLOVER, M.P., MIN, S., SCRAGG, R., BULLEN, C. MCCOOL, J., KIRA, A. The rise of the ‘rollie’ in New Zealand: Preference for loose tobacco among an ethnically diverse low socio-economic urban population. N Z Med J in press.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Marewa Glover

Address

Director
Centre for Tobacco Control Research
Social & Community Health
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6493737599 extn 86044

Fax

+6493035932

m.glover@auckland.ac.nz

Contact person for scientific queries

Name

Dr Marewa Glover

Address

Director
Centre for Tobacco Control Research
Social & Community Health
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+6493737599 extn 86044

Fax

+6493035932

m.glover@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

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