Open Access Study protocol

The study protocol for a randomized controlled trial of a family-centred tobacco control program about environmental tobacco smoke (ETS) to reduce respiratory illness in Indigenous infants

Vanessa Johnston1*, Natalie Walker2, David P Thomas1, Marewa Glover3, Anne B Chang1, Chris Bullen2, Peter Morris1, Ngiare Brown4, Stephen Vander Hoorn2, Ron Borland5, Catherine Segan6, Adrian Trenholme7, Toni Mason8, Debra Fenton7 and Kane Ellis9

Author Affiliations

1 Menzies School of Health Research, Institute of Advanced Studies, Charles Darwin University, Building 58, Royal Darwin Hospital, Darwin 0810, Australia

2 Clinical Trials Research Unit, School of Population Health, University of Auckland, 261 Morrin Road, Glen Innes, Auckland 1072, New Zealand

3 Centre for Tobacco Control Research, School of Population Health, University of Auckland, 261 Morrin Road, Glen Innes, Auckland 1072, New Zealand

4 The Poche Centre for Indigenous Health, University of Sydney, Edward Ford Building A27, Sydney 2006, Australia

5 Cancer Council Victoria, 100 Drummond Street, Melbourne 3053, Australia

6 Centre for Health Policy, Programs and Economics, University of Melbourne, 207 Bouverie St, Melbourne 3053, Australia

7 Kidz First and Women's Health Division, Counties Manukau District Health Board, Zealand Building 43, Western Campus Middlemore Hospital, Auckland, New Zealand

8 Quit Victoria, 100 Drummond Street, Melbourne 3053, Australia

9 Danila Dilba Aboriginal Health Service, 32-34 Knuckey Street, Darwin 0910, Australia

For all author emails, please log on.

BMC Public Health 2010, 10:114  doi:10.1186/1471-2458-10-114

Published: 7 March 2010

Abstract

Background

Acute respiratory illness (ARI) is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand (NZ). Environmental tobacco smoke (ETS) from household smoking is a significant and preventable contributor to childhood ARI. This paper describes the protocol for a study which aims to test the efficacy of a family-centred tobacco control program about ETS to improve the respiratory health of Indigenous infants in Australia and New Zealand. For the purpose of this paper 'Indigenous' refers to Australia's Aboriginal and Torres Strait Islander peoples when referring to Australian Indigenous populations. In New Zealand, the term 'Indigenous' refers to Māori.

Methods/Design

This study will be a parallel, randomized, controlled trial. Participants will be Indigenous women and their infants, half of whom will be randomly allocated to an 'intervention' group, who will receive the tobacco control program over three home visits in the first three months of the infant's life and half to a control group receiving 'usual care' (i.e. they will not receive the tobacco control program). Indigenous health workers will deliver the intervention, the goal of which is to reduce or eliminate infant exposure to ETS. Data collection will occur at baseline (shortly after birth) and when the infant is four months and one year of age. The primary outcome is a doctor-diagnosed, documented case of respiratory illness in participating infants.

Discussion

Interventions aimed at reducing exposure of Indigenous children to ETS have the potential for significant benefits for Indigenous communities. There is currently a dearth of evidence for the effect of tobacco control interventions to reduce children's exposure to ETS among Indigenous populations. This study will provide high-quality evidence of the efficacy of a family-centred tobacco control program on ETS to reduce respiratory illness. Outcomes of our study will be important and significant for Indigenous tobacco control in Australia and New Zealand and prevention of respiratory illness in children.

Trial registration

Australian New Zealand Clinical Trials Registry (ACTRN12609000937213)