Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000356268
Ethics application status
Approved
Date submitted
30/04/2009
Date registered
25/05/2009
Date last updated
1/12/2020
Date data sharing statement initially provided
1/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Feeding healthy food to kids - the role of parents
Scientific title
Does provision of interactive nutrition and parenting resources change the food provision and child feeding practices of parents of children aged 2 - 5 years?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood nutrition 4697 0
Condition category
Condition code
Diet and Nutrition 5011 5011 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The resource pack that the intervention group will receive will include the Tummy Rumbles CD and Raising Children DVD with accompanying instructions on how to optimally use the resources over the ensuing three and nine months intervention period. These resources are to both be used at parents' discretion. The media contain nutrition and parenting information and strategies for parents of children aged 2 - 5 years (topics include five food groups, fussy eating, label reading, child feeding). A pen and paper survey to evaluate the acceptability and utilisation of these media will be conducted at the conclusion of the study ( 9 months)
Intervention code [1] 4458 0
Behaviour
Comparator / control treatment
Participants in the control group will receive the generic Good For Kids Good For Life ‘Here’s 3 steps you should know…’ printed resource, a simple colour brochure promoting physical activity, consumption of water andfruit and vegetables. This will not be monitored as provided on the assumption that parents in control group would be likely to receive some form of nutrition and physical activity literature during the study period.
Control group
Active

Outcomes
Primary outcome [1] 5851 0
Decreased consumption of 'extras' and increased consumption of vegetables measured using a validated 137 item food frequency questionnaire at baseline, 3 months and nine months
Timepoint [1] 5851 0
Baseline, 3 months, 9 months
Secondary outcome [1] 241876 0
Changes to child feeding practices meaured using The Child Feeding Questionnaire, a 30-item questionnaire, which will be completed by parents to help identify if a relationship exists between parents child feeding practices and the actual foods and drinks consumed by children, as determined by the Food Frequency Qusetionnaire (FFQ).
Timepoint [1] 241876 0
Baseline, 3 months, 9 months
Secondary outcome [2] 241967 0
Increased variety of vegetable consumption at 9 months compared to baseline masured using food frequency questionannire described above
Timepoint [2] 241967 0
Baseline and 9 months

Eligibility
Key inclusion criteria
Parents of children aged 2 - 5 years
Minimum age
2 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Chronic childhood dieases eg Type 1 diabetes, coeliac disease

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)
Participants will be recruited through promotion of the study by allied health professionals and children's services. Those recruited by allied health professionals will be randomly allocated to intrevntion or control group. Participants recruited through childrens services will be allocated to intervention or control based on cluster randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be conducted by using a randomization table created by a computer software. Allocation of services will be conducted by pairing services based on number of families, and allocation by coin toss
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
1/05/2009
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
1/12/2009
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
200
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1638 0
2428
Recruitment postcode(s) [2] 1639 0
2430
Recruitment postcode(s) [3] 1640 0
2429
Recruitment postcode(s) [4] 1641 0
2312
Recruitment postcode(s) [5] 1642 0
2324

Funding & Sponsors
Funding source category [1] 4877 0
Government body
Name [1] 4877 0
New South Wales Institute of Rural Clinical Skills and Teaching (NSWIRCST)
Country [1] 4877 0
Australia
Primary sponsor type
Government body
Name
NSWIRCST
Address
NSW Institute of Rural Clinical Services and Teaching, PO Box 4061, DUBBO 2830
Country
Australia
Secondary sponsor category [1] 4410 0
University
Name [1] 4410 0
University of Newcastle
Address [1] 4410 0
University Drive
Callaghan NSW 2308
Country [1] 4410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6943 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 6943 0
Ethics committee country [1] 6943 0
Date submitted for ethics approval [1] 6943 0
Approval date [1] 6943 0
27/03/2009
Ethics approval number [1] 6943 0
08/12/17/4.02
Ethics committee name [2] 7114 0
Hunter New England Human Research Ethics Committee
Ethics committee address [2] 7114 0
Ethics committee country [2] 7114 0
Australia
Date submitted for ethics approval [2] 7114 0
Approval date [2] 7114 0
27/03/2009
Ethics approval number [2] 7114 0
08/12/17/4.02

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

Contacts
Principal investigator
Name 29549 0
Address 29549 0
Country 29549 0
Phone 29549 0
Fax 29549 0
Email 29549 0
Contact person for public queries
Name 12796 0
Kerith Duncanson
Address 12796 0
PO Box 448
Forster NSW 2428
Country 12796 0
Australia
Phone 12796 0
+61 2 6555 1830
Fax 12796 0
Email 12796 0
kerith.duncanson@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 3724 0
Kerith Duncanson
Address 3724 0
PO Box 448
Forster NSW 2428
Country 3724 0
Australia
Phone 3724 0
+61 2 6555 1830
Fax 3724 0
Email 3724 0
kerith.duncanson@hnehealth.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.