Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000578606
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
4/10/2005
Date last updated
5/11/2018
Date data sharing statement initially provided
5/11/2018
Date results information initially provided
5/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing obesity in children via environmental intervention: the APPLE study
Scientific title
Preventing obesity in children via environmental intervention: the APPLE study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of obesity 705 0
Condition category
Condition code
Diet and Nutrition 783 783 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two year community-based intervention aimed at increasing physical activity and healthy eating in primary school aged children through a variety of initiatives
4 intervention and 3 control schools (100% response rate) were involved from 2 distinct geographical areas in Otago, New Zealand. The nature of the community-based project precluded randomisation, but the two areas were selected on the basis of comparability with regard to sociodemographic variables.
Intervention code [1] 375 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 993 0
Two-year change in BMI z-score in intervention compared with control children
Timepoint [1] 993 0
Secondary outcome [1] 1883 0
Participation in physical activity as measured using accelerometers.
Timepoint [1] 1883 0
Secondary outcome [2] 1884 0
Dietary intake of selected foods and beverages.
Timepoint [2] 1884 0
Secondary outcome [3] 1885 0
Quality of life.
Timepoint [3] 1885 0

Eligibility
Key inclusion criteria
All healthy children attending the intervention and control schools.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/01/2003
Actual
1/08/2003
Date of last participant enrolment
Anticipated
Actual
20/12/2003
Date of last data collection
Anticipated
Actual
20/12/2007
Sample size
Target
500
Accrual to date
Final
730
Recruitment outside Australia
Country [1] 173 0
New Zealand
State/province [1] 173 0

Funding & Sponsors
Funding source category [1] 861 0
Government body
Name [1] 861 0
Health Research Council
Country [1] 861 0
New Zealand
Funding source category [2] 862 0
Charities/Societies/Foundations
Name [2] 862 0
National Heart Foundation,
Country [2] 862 0
New Zealand
Funding source category [3] 863 0
Charities/Societies/Foundations
Name [3] 863 0
Community Trust of Otago
Country [3] 863 0
New Zealand
Funding source category [4] 864 0
University
Name [4] 864 0
University of Otago
Country [4] 864 0
New Zealand
Funding source category [5] 865 0
Charities/Societies/Foundations
Name [5] 865 0
Otago Diabetes Research Trust
Country [5] 865 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 730 0
Individual
Name [1] 730 0
Dr Rachael Taylor
Address [1] 730 0
Country [1] 730 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301853 0
University of Otago Ethics Committee
Ethics committee address [1] 301853 0
University of Otago
Dunedin
Ethics committee country [1] 301853 0
New Zealand
Date submitted for ethics approval [1] 301853 0
31/08/2002
Approval date [1] 301853 0
12/09/2002
Ethics approval number [1] 301853 0
N/A

Summary
Brief summary
Trial website
Trial related presentations / publications
1. Williden M, Taylor RW, McAuley KA, Simpson JC, Oakley M, Mann JI. The APPLE project: an investigation of the barriers and promoters of healthy eating and physical activity in children aged 5-12 years. Health Educat J. 2006;65(2):135-148.
2. Taylor RW, McAuley KA, Barbezat W, Strong A, Williams SM, Mann JI. APPLE project: 2-y findings of a community-based obesity prevention program in primary school-age children. Am J Clin Nutr. 2007;86(3):735-742.
3. Taylor RW, McAuley KA, Barbezat W, Farmer VL, Williams SM, Mann JI. Two-year follow-up of an obesity prevention initiative in children: the APPLE project. Am J Clin Nutr. 2008;88(12):1371-1377.
4. McAuley KA, Taylor RW, Farmer L, Hansen PL, Williams SM, Mann JI. Economic evaluation of a community-based obesity prevention programme in children: the APPLE project. Obesity. 2009;18:131-136.
5. Nielsen G, Taylor RW, Williams SM, Mann JI. Permanent play facilities in school playgrounds as a determinant of children’s activity. Journal of Physical Activity and Health. 2010;7:490-496
Public notes

Contacts
Principal investigator
Name 35706 0
Address 35706 0
Country 35706 0
Phone 35706 0
Fax 35706 0
Email 35706 0
Contact person for public queries
Name 9564 0
Dr Rachael Taylor
Address 9564 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9001
Country 9564 0
New Zealand
Phone 9564 0
+64 3 4795262
Fax 9564 0
Email 9564 0
rachael.taylor@stonebow.otago.ac.nz
Contact person for scientific queries
Name 492 0
Dr Rachael Taylor
Address 492 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9001
Country 492 0
New Zealand
Phone 492 0
+64 3 4795262
Fax 492 0
Email 492 0
rachael.taylor@stonebow.otago.ac.nz

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.