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Trial registered on ANZCTR


Registration number
ACTRN12610000132044
Ethics application status
Approved
Date submitted
5/02/2010
Date registered
9/02/2010
Date last updated
9/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Project Energize
Happy healthy children of all shapes and sizes. A programme to reduce obesity in children via a through-school physical activity and nutrition intervention.
Scientific title
A programme to reduce obesity in children via a through-school physical activity and nutrition intervention.
Secondary ID [1] 1386 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of obesity 256759 0
obesity 256761 0
Condition category
Condition code
Diet and Nutrition 256909 256909 0 0
Obesity
Public Health 256911 256911 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Project Energize is a school-based nutrition and activity programme which aims to increase children’s activity levels, reduce sedentary time, and optimise nutritional
intake through changes in the school environment and culture. Potential benefits of this include increased ability to participate, improved body composition, improved dental health, and improvements in a range of associated health measures.
In 2004 primary schools (124) in the Waikato district were randomised to an intervention (62) or control (62). Energize staff (‘Energizers’) work with between 6 and 8 schools and each school developed with the Energizer an individualised action plan based on the individual needs of the school.
Supported by the Energizer within the school, physical activity interventions were aimed at encouraging and aiming for 20 minutes of high intensity physical activity every day; Increasing children’s lunchtime physical activity; Increasing children’s exercise everyday at home; and Increasing children’s incidental activity. The optimisation of children's nutritional intake was by Encouraging the ready provision of water for all children and promoting water intake; Decreasing children’s carbonated beverage intake (at school and at home); Decreasing the availability of energy dense foods at school and home;and Increasing fruit and vegetable intake at school and home.
Examples of facilitation include physical activity sessions modelled with teacher, leadership training for senior students, home school link programmes established, physical education and nutrition curriculum assistance, schools supported to achieve the National Heart Foundation's school food programme, works shops for sportiing disciplines provided.
The control schools were on a wait-list and are now all receiving the intervention as are all primary schools in the Waikato district.
Intervention code [1] 255971 0
Lifestyle
Comparator / control treatment
After two years the control schools also received Programme Energize and now (2010) all (256) primary schools in the Waikato have been offered the programme with only 2 refusals
Control group
Active

Outcomes
Primary outcome [1] 257784 0
Outcome of reduction of prevalence of obesity measured as a two year reduction in body mass index (BMI) z-score in intervention compared with control children. Centres for Disease Control grwoth charts. Adv Data. 2000:1-27.
Timepoint [1] 257784 0
Two years from baseline
Primary outcome [2] 257785 0
Two year reduction in blood pressure in intervention compared with control children. Resting blood pressure measured with an Omron Auto Blood Pressure monitor T8 and compared to blood pressure centiles for Great Britain Arch Dis Child 2007;92:298?303
Timepoint [2] 257785 0
Two years from baseline
Secondary outcome [1] 263186 0
Two year reduction in percentage body fat in intervention compared with control children. Measured by single frequency 50kHz hand to foot bioimpedance and standardised against the McCarthy Cole centiles. Int J Obes (Lond). 2006; 30:598-602.
Timepoint [1] 263186 0
Two years from baseline

Eligibility
Key inclusion criteria
All children in the schools are exposed to the intervention but only children aged 5 and 10 years at baseline were invited to be included evaluation cohorts
Minimum age
5 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not aged 5 or 10 years at time of recruitment into the evaluation cohort.
No other exclusions providing usual caregiver and child had signed informed consent

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)
Schools (not children) were randomised in a stratified manner by location, size of school, ethnicity of children and school decile. Randomisation of the school occured after recruitment of schools and schools notified of their status. Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number was generated electronically for each school within the Statistical Package for the Social Sciences statistical software package (SPSS Inc., Chicago,IL, USA). Intervention schools within any stratum were selected from highest to lowest random number, and control schools from lowest to highest.
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
1/10/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
167
Accrual to date
Final
Recruitment outside Australia
Country [1] 2467 0
New Zealand
State/province [1] 2467 0
Waikato

Funding & Sponsors
Funding source category [1] 256469 0
Government body
Name [1] 256469 0
Waikato District Health Baord
Country [1] 256469 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Sport Waikato
Address
Brian Perry Sports House, Avalon Drive, Hamilton 3200.
PO Box 46, Hamilton 3240.
Country
New Zealand
Secondary sponsor category [1] 255779 0
Government body
Name [1] 255779 0
Ministry of Health
Address [1] 255779 0
133 Molesworth Street
Thorndon
Wellington
6011
Country [1] 255779 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258522 0
Northern Y ethics committee
Ethics committee address [1] 258522 0
Ethics committee country [1] 258522 0
New Zealand
Date submitted for ethics approval [1] 258522 0
Approval date [1] 258522 0
11/08/2004
Ethics approval number [1] 258522 0
WAI/04/05/044

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

Contacts
Principal investigator
Name 30806 0
Address 30806 0
Country 30806 0
Phone 30806 0
Fax 30806 0
Email 30806 0
Contact person for public queries
Name 14053 0
Dr David Graham
Address 14053 0
Child Health, Waikato Hospital, PO Box 3200, Hamilton, New Zealand
Country 14053 0
New Zealand
Phone 14053 0
+6478398899
Fax 14053 0
Email 14053 0
[email protected]
Contact person for scientific queries
Name 4981 0
Professor Elaine Rush
Address 4981 0
AUT University
Private Bag 92006
Auckland 1142
Country 4981 0
New Zealand
Phone 4981 0
+64 9 921 9999
Fax 4981 0
Email 4981 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
SourceTitleYear of PublicationDOI
Dimensions AIProject Energize: intervention development and 10 years of progress in preventing childhood obesity2016https://doi.org/10.1186/s13104-016-1849-1
N.B. These documents automatically identified may not have been verified by the study sponsor.