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Trial registered on ANZCTR


Registration number
ACTRN12609000937213
Ethics application status
Approved
Date submitted
30/10/2009
Date registered
2/11/2009
Date last updated
3/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A family tobacco control program to reduce respiratory illness in Indigenous infants.
Scientific title
A randomised controlled trial of a family-centred tobacco control program about environmental tobacco smoke (ETS) to reduce respiratory illness in Indigenous infants.
Secondary ID [1] 1365 0
Healthy Starts / Te Piripohotanga
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of respiratory illness among Indigenous infants 252087 0
Prevention of environmental tobacco smoke exposure of Indigenous infants 252088 0
Condition category
Condition code
Respiratory 252293 252293 0 0
Other respiratory disorders / diseases
Public Health 252294 252294 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘intervention’ is a family-centred tobacco control program which will (i) provide education about the health effects of ETS exposure and use behavioural ‘coaching’ techniques to help mothers implement strategies to reduce the infant’s ETS exposure, as well as ii) identify mothers’ and other household members’ motivation to quit smoking (if applicable) and deliver culturally appropriate smoking cessation counselling and treatment options (e.g. nicotine replacement therapy) as requested. The program will be led by Indigenous Health Workers and it will be delivered at three face-to-face home visits conducted over the first three months of the infant’s life.
Intervention code [1] 241478 0
Behaviour
Comparator / control treatment
The control group will receive 'usual' care through their comunity health provder. Usual care entails routine visits to maternal and child health providers at several defined timepoints during the first 12 months of the infant's life. At these postnatal visits, health providers check developmental milestones and general wellbeing. Additionally, mothers/caregivers routinely receive messages about smoking cessation and ETS exposure in their homes during these visits as part of general health promotion.
Control group
Active

Outcomes
Primary outcome [1] 253162 0
Rate of health provider presentations for new primary episodes of acute respiratory illness (ARI) in the first year of life.
A new illness will be defined as onset after at least two days without any respiratory symptoms or signs. To identify episodes of respiratory illness mothers/caregivers will be asked at specific timepoints whether their child has had any presentation to the clinic or hospital and the names of the clinics attended. A research assistant will be responsible for collecting the source data relevant to the primary outcome measures, and will review the individual child's health provider and hospital clinic records (parental consent will be obtained prior to accessing records). Source documents will be photocopied, de-identified, labelled with the participant registration, and stored with the trial records. Two clinicians (blinded to group allocation) will review the wording used in clinic records and confirm documented respiratory illnesses.
Timepoint [1] 253162 0
Primary outcome data will be collected at baseline (when the infant is 5 weeks old), and after the intervention program has been delivered at 4 months of age (short term follow up) and 12 months of age (long term follow up).
Secondary outcome [1] 262063 0
Rate of hospitalisations for acute respiratory illness (ARI) in the first year of life. Same definition as primary outcome.
Timepoint [1] 262063 0
Infant aged 5 weeks (baseline), 4 months and 12 months
Secondary outcome [2] 262064 0
Mother/caregiver's self-report of infant's exposure to ETS: Number of days in the preceding seven days in which infant was exposed to ETS (same room in a house with a person who smokes, in a car with a person who smokes, or sitting outside within arm's length of someone who smokes).
Timepoint [2] 262064 0
Infant aged 5 weeks, 4 months and 12 months
Secondary outcome [3] 262065 0
Mother/caregiver's self-report of smoking restrictions in the home and car.
Timepoint [3] 262065 0
Infant aged 5 weeks, 4 months and 12 months
Secondary outcome [4] 262066 0
Mother/caregiver's self-report of smoking cessation: defined as mother/caregiver not smoking a single cigarette (not even a puff), in the preceding seven days. We will also be assessing prolonged abstinence (e.g. quit for 3 months at 4 month follow up; quit for 9 months at 12 month follow-up).
Timepoint [4] 262066 0
Infant aged 5 weeks, 4 months and 12 months
Secondary outcome [5] 262067 0
Mother/caregiver's self-report of number quit attempts: defined as not smoking a cigarette for at least 24 hours
Timepoint [5] 262067 0
Infant aged 5 weeks, 4 months and 12 months
Secondary outcome [6] 262068 0
Process evaluation indicators: a mix of quantitative and qualitative measures will be collected related to the 'intervention' program (e.g. number of 'coaching' activities completed, obstacles and successes in delivering program, parent satisfaction with the program). This will only apply to the intervention arm.
Timepoint [6] 262068 0
Infant aged 5 weeks, 8 weeks and 12 weeks

Eligibility
Key inclusion criteria
Infants will be eligible for inclusion if: 1. They are aged between 0-5 weeks. We will review our recruitment rate four months after the trial has commenced. If we find that we are not meeting our enrolment targets, we will consider extending our recruitment to include infants aged 5-10 weeks. This will allow us to approach mothers and their infants at 6-8 weeks when they present at community health clinics for their first immunizations. 2. Their mother/caregiver is Indigenous (defined by maternal self-identification). 3. Their mother/caregiver is aged 16 years or over. 4. Their mother/caregiver currently smokes or if the infant lives in a household where there is at least one other person who smokes (defined as smoking at least weekly). 5. Their mother/caregiver plans to reside permanently with the infant in Darwin or Greater Darwin areas of Australia or within the Counties Manukau District Health Board region, Manukau, NZ. 6. Their mother/caregiver has given signed written consent to participate in this research study. 7. Their mother/caregiver has given signed written consent for study staff to access the infant’s health records. 8. They are a singleton or the first born in a multiple pregnancy delivery. 9. Their mother/caregiver speaks English and/or Maori.
Minimum age
0 Hours
Maximum age
5 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infants will be excluded from the trial if:
1. They have serious neonatal respiratory complications (i.e. they require oxygen for >24 hours during their postnatal hospital stay).
2. They have other serious neonatal complications (e.g. seizures, significant sepsis).
3. They have major organ abnormalities (i.e. cardiac disease, congenital lung/diaphragm abnormalities, chromosomal abnormality or syndrome e.g. Down’s syndrome).
4. Their mother/caregiver has previously been recruited in this research study.
5. They live in the same household as a mother/caregiver who has previously been recruited in this study.

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)
We will conduct a parallel randomised controlled study with concealed allocation using central randomisation by computer. All potential participants (i.e. the infants) will be assigned a unique registration number allocated by a central computer following details submitted on a web-based form. This number will be used to identify each randomized participant, once consent is obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized by computer with stratification by country (Australia, NZ) and infant age (0-5 weeks, >5 -10 weeks) to ensure a balance in these key prognostic indicators between the intervention and control groups. The randomization will also use permuted blocks within strata to ensure balance between treatment groups over time.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
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
9/11/2009
Actual
1/12/2009
Date of last participant enrolment
Anticipated
Actual
5/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
420
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment outside Australia
Country [1] 2301 0
New Zealand
State/province [1] 2301 0
Auckland

Funding & Sponsors
Funding source category [1] 243944 0
Government body
Name [1] 243944 0
The National Health and Medical Research Council of Australia (Project grant number 545203)
Country [1] 243944 0
Australia
Funding source category [2] 243945 0
Government body
Name [2] 243945 0
Health Research Council of NZ (Project grant number 09/626)
Country [2] 243945 0
New Zealand
Funding source category [3] 289034 0
Charities/Societies/Foundations
Name [3] 289034 0
Cure Kids NZ (Grant 3525)
Country [3] 289034 0
New Zealand
Primary sponsor type
University
Name
Menzies School of Health Research
Address
PO Box 41096
Casuarina
Northern Territory 0811
Country
Australia
Secondary sponsor category [1] 251301 0
University
Name [1] 251301 0
University of Auckland (Clinical Trials Research Unit)
Address [1] 251301 0
Private Bag 92019
Auckland 1142
Country [1] 251301 0
New Zealand
Other collaborator category [1] 917 0
Other
Name [1] 917 0
Danila Dilba Health Service
Address [1] 917 0
32-34 Knuckey Street
Darwin
Northern Territory 0910
Country [1] 917 0
Australia
Other collaborator category [2] 918 0
Hospital
Name [2] 918 0
Middlemore Hospital
Address [2] 918 0
Private Bag 93311
Otahuhu
Auckland 1640
Country [2] 918 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244060 0
The Human Research Ethics Committee of the Northern Territory Department of Health & Families and the Menzies School of Health Research
Ethics committee address [1] 244060 0
Menzies School of Health Research
PO Box 41096
Casuarina
Northern Territory 0811
Ethics committee country [1] 244060 0
Australia
Date submitted for ethics approval [1] 244060 0
Approval date [1] 244060 0
11/05/2009
Ethics approval number [1] 244060 0
09/32
Ethics committee name [2] 244092 0
Northern Y Regional Ethics Committee, New Zealand Ministry of Health
Ethics committee address [2] 244092 0
PO Box 1030
Hamilton,
Auckland
Ethics committee country [2] 244092 0
New Zealand
Date submitted for ethics approval [2] 244092 0
Approval date [2] 244092 0
30/10/2009
Ethics approval number [2] 244092 0
NTY/09/09/091

Summary
Brief summary
Acute Respiratory Illness is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand. Parental smoking is a significant and preventable source of childhood morbidity, especially related to respiratory illness. Rates of adult smoking amongst Indigenous Australians and Maori are much higher compared with non-Indigenous populations; consequently Indigenous infants in both countries have higher rates of exposure to environmental tobacco smoke (ETS), compared with non-Indigenous children. The aim of this study is to trial the effect of a family-centred tobacco control program about ETS on the respiratory health of Indigenous infants up to 12 months of age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30440 0
A/Prof David Thomas
Address 30440 0
Menzies School of Health Research and the Lowitja Institute, Charles Darwin University; Darwin, Australia
PO Box 41096, Casuarina NT 0811
Country 30440 0
Australia
Phone 30440 0
+61 8 89227610
Fax 30440 0
Email 30440 0
[email protected]
Contact person for public queries
Name 13687 0
Dr. Vanessa Johnston
Address 13687 0
Menzies School of Health Research
PO Box 41096
Casuarina
Northern Territory 0811
Country 13687 0
Australia
Phone 13687 0
+61 (0)8 8922 7968
Fax 13687 0
+61 (0)8 8927 5187
Email 13687 0
[email protected]
Contact person for scientific queries
Name 4615 0
Dr. Vanessa Johnston
Address 4615 0
Menzies School of Health Research
PO Box 41096
Casuarina
Northern Territory 0811
Country 4615 0
Australia
Phone 4615 0
+61 (0)8 8922 7968
Fax 4615 0
+61 (0)8 8927 5187
Email 4615 0
[email protected]

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