Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000374460
Ethics application status
Approved
Date submitted
10/05/2007
Date registered
16/07/2007
Date last updated
29/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Romp & Chomp: A community-based intervention program to promote healthy eating and physical activity in under 5s in the City of Greater Geelong
Scientific title
A study in pre-school children of multiple strategies to increase the community's capacity to promote healthy eating and physical activity compared to no specific interventions on the prevalence of overweight and obesity
Secondary ID [1] 288655 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity in pre-school children. 1954 0
Condition category
Condition code
Diet and Nutrition 2049 2049 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Multiple strategies over 3 years (2005-2008) to increase community capacity to increase healthy eating and physical activity in pre-school children. Examples of strategies include food policies in child care settings, active play programs, social marketing, promotion of water, training of early childhood professionals, and parent education.
Intervention code [1] 1749 0
Prevention
Comparator / control treatment
Comparison: Background activities in the region, no specific interventions, comparison period will be the same 3 years (2005-2008).
Control group
Active

Outcomes
Primary outcome [1] 2878 0
Change in the prevalence of overweight and obesity calculated from measured height and weight from routinely collected anthropometry in 2 and 3.5 year olds.
Timepoint [1] 2878 0
Serial cross-sectional measurements (different children each year) taken throughout the year. Pre-intervention trends (2000-2005) will be compared to trends during the intervention period (2005-8) in both intervention and comparison populations.
Secondary outcome [1] 4853 0
Behavioural indicators of healthy eating and physical activity (parent questionnaire)
Timepoint [1] 4853 0
Measured at baseline (2005-2006) and after 3 years of intervention (2008-9)
Secondary outcome [2] 4854 0
Settings audits (questionnaire)
Timepoint [2] 4854 0
Measured at baseline (2005-2006) and after 3 years of intervention (2008-9)

Eligibility
Key inclusion criteria
Inclusion for anthropometry: All children attending Maternal and Child Health (MCH) Key Age and Stages visits for 2 and 3.5 years Inclusion for behaviours: Parents attending MCH 2 and 3.5 year Age and Stage visits within the data collection time period. Inclusions for Settings audits: Kindergartens, long daycare, family daycare settings in the intervention and comparison areas.
Minimum age
2 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion for anthropometry: participants with missing data and outlying data indicating data entry errors. Exclusions for audits: nil

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
5/04/2005
Date of last participant enrolment
Anticipated
Actual
1/01/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
30000
Accrual to date
Final
36000
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 2194 0
Government body
Name [1] 2194 0
Department of Human Services, Victoria
Country [1] 2194 0
Australia
Primary sponsor type
University
Name
School of Exercise and Nutrition Sciences, Deakin University
Address
Gheringhap Street,
Geelong, Victoria 3217,
Country
Australia
Secondary sponsor category [1] 1978 0
Government body
Name [1] 1978 0
Victorian Government, Office for Children
Address [1] 1978 0
Lonsdale St Melbourne 3000 Vic
Country [1] 1978 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3992 0
All kindergartens, long day care, family day care and MCH sites across Victoria-Deakin University Human Research Ethics Committee
Ethics committee address [1] 3992 0
Ethics committee country [1] 3992 0
Australia
Date submitted for ethics approval [1] 3992 0
Approval date [1] 3992 0
04/04/2005
Ethics approval number [1] 3992 0
EC 23-2005

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

Contacts
Principal investigator
Name 27852 0
Prof Boyd Swinburn
Address 27852 0
Gheringhap Street,
Geelong, Victoria 3217,
Country 27852 0
Australia
Phone 27852 0
+64221679636
Fax 27852 0
Email 27852 0
[email protected]
Contact person for public queries
Name 10938 0
Boyd swinburn
Address 10938 0
Deakin University
Waterfront Campus
1 Gheringhap St
Geelong VIC 3127
Country 10938 0
Australia
Phone 10938 0
+61 3 52270369
Fax 10938 0
Email 10938 0
[email protected]
Contact person for scientific queries
Name 1866 0
Boyd Swinburn
Address 1866 0
Deakin University
221 Burwood Highway
Melbourne VIC 3125
Country 1866 0
Australia
Phone 1866 0
+61 3 92517096
Fax 1866 0
Email 1866 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.