Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000126516
Ethics application status
Approved
Date submitted
27/01/2015
Date registered
11/02/2015
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the Garden to Table project in low decile Wellington schools.
Scientific title
An evaluation of the Garden to Table project in low decile primary school children on diet quality and body weight.
Secondary ID [1] 286051 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 294032 0
Condition category
Condition code
Diet and Nutrition 294334 294334 0 0
Obesity
Public Health 294407 294407 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention children will attend Garden To Table classes weekly which includes planting and tending a vegetable garden, and cooking and eating the produce. Classes are once per week for one hour and run for the school year (4 terms). Classes are run by the GTT coordinator for that school, after training from the GTT national program.
Intervention code [1] 291039 0
Prevention
Intervention code [2] 291088 0
Lifestyle
Comparator / control treatment
The control children will not attend any form of gardening or cooking classes, they will receive standard schooling only.
Control group
Active

Outcomes
Primary outcome [1] 294133 0
BMI z-score
Timepoint [1] 294133 0
3 years
Primary outcome [2] 294134 0
Diet quality by childrens dietary questionnaire score
Timepoint [2] 294134 0
3 years
Primary outcome [3] 294135 0
Waist circumference assessed by flexible tape measure
Timepoint [3] 294135 0
3 years
Secondary outcome [1] 312586 0
Body fat percentage assessed by Tanita scale
Timepoint [1] 312586 0
3 years
Secondary outcome [2] 312587 0
Qualitative measures through focus groups, measuring change in childrens knowledge and preference toward fruit and vegetables, and a process evaluation at the end of the year of the GTT program.
Timepoint [2] 312587 0
3 years

Eligibility
Key inclusion criteria
CHildren in years 5 and 6, at low decile (3 or less) schools participating in the Garden to Table program.
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children under the age of 7 or not participating in the GTT classes for whatever reason.

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)
Information sheets will be sent to all classes in the Garden to table program. Parents/caregivers who choose for their child to participate will sign consent form.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
1/03/2015
Actual
2/03/2015
Date of last participant enrolment
Anticipated
3/04/2017
Actual
7/03/2016
Date of last data collection
Anticipated
15/12/2017
Actual
4/12/2017
Sample size
Target
75
Accrual to date
Final
119
Recruitment outside Australia
Country [1] 6615 0
New Zealand
State/province [1] 6615 0

Funding & Sponsors
Funding source category [1] 290638 0
Charities/Societies/Foundations
Name [1] 290638 0
Healthy Future Families Trust
Country [1] 290638 0
New Zealand
Primary sponsor type
Government body
Name
Capital and Coast District Health Board
Address
Riddford St
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 289332 0
None
Name [1] 289332 0
Address [1] 289332 0
Country [1] 289332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292271 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 292271 0
Ethics committee country [1] 292271 0
New Zealand
Date submitted for ethics approval [1] 292271 0
Approval date [1] 292271 0
17/11/2014
Ethics approval number [1] 292271 0
14/CEN/180

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

Contacts
Principal investigator
Name 50958 0
Dr Amber Parry Strong
Address 50958 0
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country 50958 0
New Zealand
Phone 50958 0
+64 4 8062458
Fax 50958 0
Email 50958 0
[email protected]
Contact person for public queries
Name 50959 0
Amber Parry Strong
Address 50959 0
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country 50959 0
New Zealand
Phone 50959 0
+64 04 8062458
Fax 50959 0
Email 50959 0
[email protected]
Contact person for scientific queries
Name 50960 0
Amber Parry Strong
Address 50960 0
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country 50960 0
New Zealand
Phone 50960 0
+64 04 8062458
Fax 50960 0
Email 50960 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.