Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000414415
Ethics application status
Approved
Date submitted
7/08/2007
Date registered
15/08/2007
Date last updated
15/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of eat well be active (EWBA) Community Programs
Scientific title
A 3-year study in primary school children of a multi-strategy, community development intervention promoting healthy eating, physical activity and water consumption compared to no specific interventions on levels of fruit, vegetable, water consumption, physical activity and body size and composition.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood and adolescent (0-18 years) overweight and obesity 2223 0
Condition category
Condition code
Diet and Nutrition 2315 2315 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions are located in one metropolitan and one rural community. A portfolio of sustainable strategies over 3 years within multiple settings (long day care, family day care, primary schools, high schools, out of school hours care). Examples include food policies, training for teachers and coordinators, curriculum on healthy eating and physical activity, social marketing, development of resources.
The metropolitan comparison site is exposed to background activities in the regions, with no specific interventions instituted, while the rural comparison site has no specific interventions instituted.
Intervention code [1] 1934 0
Prevention
Comparator / control treatment
Both the rural and metropolitan comaprison sites have no specific interventions instituted.
Control group
Active

Outcomes
Primary outcome [1] 3211 0
Increased consumption of fruit, vegetables and water will be measured by administering self-report surveys to year 5,6& 7 students in the control and comparison sites.
Timepoint [1] 3211 0
A self-report survey will be administered to students for them to report their fruit, vegetable and water consumption in August 2006 and again in August 2009.
Primary outcome [2] 3212 0
Increased levels of physical activity will be measured by administering self-report surveys to year 5,6& 7 students in the control and comparison sites.
Timepoint [2] 3212 0
A self-report survey will be administered to students for them to report their levels of physical activity in August 2006 and again in August 2009.
Secondary outcome [1] 5350 0
Body Mass Index
Body Mass Index z-score
Timepoint [1] 5350 0
All will be measured in year 5,6 & 7 students at baseline (2006) and at follow-up (2009).
Secondary outcome [2] 5351 0
Waist circumference
Waist circumference z-score
Timepoint [2] 5351 0
All will be measured in year 5,6 & 7 students at baseline (2006) and at follow-up (2009).
Secondary outcome [3] 5352 0
Behavioural, attitudes and knowledge indicators of healthy eating and physical activity
Timepoint [3] 5352 0
All will be measured in year 5,6 & 7 students at baseline (2006) and at follow-up (2009).
Secondary outcome [4] 5353 0
Parent, principal, teacher and canteen surveys in primary schools
Timepoint [4] 5353 0
Parents, principals, teachers and canteens in primary schools will be measured at baseline (2006) and at follow-up (2009).
Secondary outcome [5] 5354 0
Principal and canteen surveys in high schools
Timepoint [5] 5354 0
Principal and canteen surveys in high schools will be measured at baseline (2006) and at follow-up (2009).
Secondary outcome [6] 5355 0
Pre-school, long day care, family day care and out of school hours care surveys
Timepoint [6] 5355 0
Pre-school, long day care, family day care and out of school hours care surveys will be measured at baseline (2006) and at follow-up (2009).

Eligibility
Key inclusion criteria
Inclusion for measurement: male and female students in year 5, 6 & 7 in intervention and comparison sites. Parental and student consents completed.
Minimum age
9 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lack of parental or student consent.

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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 217 0
5162
Recruitment postcode(s) [2] 360 0
5253
Recruitment postcode(s) [3] 361 0
5254
Recruitment postcode(s) [4] 362 0
5540
Recruitment postcode(s) [5] 363 0
5163
Recruitment postcode(s) [6] 364 0
5164
Recruitment postcode(s) [7] 365 0
5165
Recruitment postcode(s) [8] 366 0
5166
Recruitment postcode(s) [9] 367 0
5167
Recruitment postcode(s) [10] 368 0
5168
Recruitment postcode(s) [11] 369 0
5169
Recruitment postcode(s) [12] 370 0
5259
Recruitment postcode(s) [13] 371 0
5523
Recruitment postcode(s) [14] 372 0
5495

Funding & Sponsors
Funding source category [1] 2480 0
Government body
Name [1] 2480 0
Department of Health Government of South Australia
Country [1] 2480 0
Australia
Primary sponsor type
Government body
Name
Department of Health Government of South Australia
Address
Department for Health
Hindmarsh Square
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 2254 0
None
Name [1] 2254 0
nil
Address [1] 2254 0
Country [1] 2254 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4384 0
Department of Health Human Research Ethics Committee
Ethics committee address [1] 4384 0
Ethics committee country [1] 4384 0
Australia
Date submitted for ethics approval [1] 4384 0
01/07/2006
Approval date [1] 4384 0
31/07/2006
Ethics approval number [1] 4384 0
156/07/2009
Ethics committee name [2] 4385 0
Department of Education and Children?s Services
Ethics committee address [2] 4385 0
Ethics committee country [2] 4385 0
Australia
Date submitted for ethics approval [2] 4385 0
01/07/2006
Approval date [2] 4385 0
18/07/2006
Ethics approval number [2] 4385 0
CS/06/0116-2.7

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

Contacts
Principal investigator
Name 27748 0
Address 27748 0
Country 27748 0
Phone 27748 0
Fax 27748 0
Email 27748 0
Contact person for public queries
Name 11123 0
Dr Michelle Jones
Address 11123 0
Southern Primary Health – Noarlunga
PO Box 437
Noarlunga Centre
SA 5168
Country 11123 0
Australia
Phone 11123 0
+ 61 8 8384 9704
Fax 11123 0
+ 61 8 8384 9248
Email 11123 0
[email protected]
Contact person for scientific queries
Name 2051 0
Dr Anthea Magarey
Address 2051 0
Department of Nutrition & Dietetics
Flinders University of South Australia
Country 2051 0
Australia
Phone 2051 0
+61 8 8204 6304
Fax 2051 0
+61 8 8204 6406
Email 2051 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.