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Trial registered on ANZCTR


Registration number
ACTRN12611000997954
Ethics application status
Approved
Date submitted
16/09/2011
Date registered
19/09/2011
Date last updated
7/07/2020
Date data sharing statement initially provided
7/07/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early Childhood Oral Health Promotion
Scientific title
Brief motivational interviewing intervention among parents of new-born children to reduce early childhood caries
Secondary ID [1] 263052 0
nil
Universal Trial Number (UTN)
U1111-1124-5874
Trial acronym
EChOHP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
early childhood dental caries 270784 0
childhood obesity 270785 0
Condition category
Condition code
Oral and Gastrointestinal 270972 270972 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 270973 270973 0 0
Health promotion/education
Public Health 270974 270974 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief motivational interviewing counseling session provided by a trained oral health counselor with parent/carer of child at approximately 8 weeks age and then at 3-4 months of age and at 6 months of age. Brief motivational interviewing approach, which has been used in many different settings, relies on a brief empathic counselling session where the client is helped to explore and verbalize the reasons for changing the health behaviour, and find the reasons for the change themselves. The impetus for change stems from the person and is not imposed by the counselor; the client is the initiator and an active participant in the change process and not merely a recipient of information being delivered by an expert. The counseling sessions will take approximately 45 minutes.
Intervention code [1] 269398 0
Behaviour
Intervention code [2] 269399 0
Lifestyle
Intervention code [3] 269400 0
Prevention
Comparator / control treatment
The control group will be provided with standard "Lift the Lip" oral health screening of the child by child health nurses of the Health Department of WA at 8, 18 and 36 months of age
Control group
Active

Outcomes
Primary outcome [1] 279639 0
caries incidence and increment.
Children will be examined for incidence of dental caries and the presence of enamel defects by blinded, calibrated examiners at 12, 24, 36 months of age, using the criteria specified by Workshop on Reporting Early Childhood Caries and modified Development Defects of Enamel Index.
Timepoint [1] 279639 0
At 12, 24, and 36 months of age
Primary outcome [2] 279640 0
early childhood obesity
Timepoint [2] 279640 0
BMI at 12, 24, and 36 months of age
Secondary outcome [1] 294108 0
change in attitudes, self-efficacy and knowledge of parent/caregivers.
A questionnaire at baseline, 12 and 36 months will collect socio-demographic information as well as information on psychosocial measures comprising oral health-related self-efficacy, knowledge about appropriate baby bottle use and children's oral hygiene and belief in oral fatalism based on that operationalised by Finlayson et.al; parental stress and social support.
Timepoint [1] 294108 0
At 12 and 36 months of age

Eligibility
Key inclusion criteria
parents with healthy new-born child attending their local child health/community health clinic for routine health check.
Minimum age
6 Weeks
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children with developmental disabilities.

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)
Consenting participants allocated using computer-generated random permuted block. Central study coordinator will assign allocation upon receipt of consent and then the counselors advised of participant allocation for intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised sequence generated by computer-generated block using Stata statistical package.
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
1/08/2011
Actual
7/07/2011
Date of last participant enrolment
Anticipated
Actual
6/02/2014
Date of last data collection
Anticipated
Actual
14/11/2018
Sample size
Target
1500
Accrual to date
Final
919
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 4513 0
6062
Recruitment postcode(s) [2] 4514 0
6168
Recruitment postcode(s) [3] 4515 0
6230

Funding & Sponsors
Funding source category [1] 269864 0
Government body
Name [1] 269864 0
Dental Health Service, Health Department Western Australia
Country [1] 269864 0
Australia
Primary sponsor type
Government body
Name
Dental Health Service, Health department Western Australia
Address
43 Mt Henry Road
Como,
Western Australia, 6152
Country
Australia
Secondary sponsor category [1] 268886 0
None
Name [1] 268886 0
Address [1] 268886 0
Country [1] 268886 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271835 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [1] 271835 0
Ethics committee country [1] 271835 0
Australia
Date submitted for ethics approval [1] 271835 0
01/03/2011
Approval date [1] 271835 0
23/08/2011
Ethics approval number [1] 271835 0
1900/EP
Ethics committee name [2] 271838 0
WA Country Health Service Ethics Committee
Ethics committee address [2] 271838 0
Ethics committee country [2] 271838 0
Australia
Date submitted for ethics approval [2] 271838 0
Approval date [2] 271838 0
23/05/2011
Ethics approval number [2] 271838 0
2011:05

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

Contacts
Principal investigator
Name 33164 0
Dr peter arrow
Address 33164 0
43 Mt Henry Road, Como, 6152, Western Australia
Country 33164 0
Australia
Phone 33164 0
+61 8 93130 600
Fax 33164 0
Email 33164 0
parrow@ozemail.com.au
Contact person for public queries
Name 16411 0
peter arrow
Address 16411 0
Locked Bag 15
BENTLEY DELIVERY CENTRE
Western Australia, 6983
Country 16411 0
Australia
Phone 16411 0
+61 8 93130600
Fax 16411 0
Email 16411 0
parrow@ozemail.com.au
Contact person for scientific queries
Name 7339 0
peter arrow
Address 7339 0
Locked Bag 15
BENTLEY DELIVERY CENTRE
Western Australia, 6983
Country 7339 0
Australia
Phone 7339 0
+61 8 93130600
Fax 7339 0
Email 7339 0
parrow@ozemail.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.