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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.
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Scientific title
A programme to reduce obesity in children via a through-school physical activity and nutrition intervention.
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Secondary ID [1]
1386
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prevention of obesity
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obesity
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Condition category
Condition code
Diet and Nutrition
256909
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0
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Obesity
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Public Health
256911
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0
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Epidemiology
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Lifestyle
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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
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Two years from baseline
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Primary outcome [2]
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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
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Assessment method [2]
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Timepoint [2]
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Two years from baseline
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Two years from baseline
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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
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Minimum age
5
Years
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Maximum age
10
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2004
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
167
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Waikato
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Waikato District Health Baord
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Address [1]
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Hockin Building
Waikato Hospital Campus
Selwyn Street
PO Box 934
Hamilton 3240
NEW ZEALAND
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Country [1]
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New Zealand
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Primary sponsor type
Charities/Societies/Foundations
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Name
Sport Waikato
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Address
Brian Perry Sports House, Avalon Drive, Hamilton 3200.
PO Box 46, Hamilton 3240.
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Country
New Zealand
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Secondary sponsor category [1]
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Government body
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Name [1]
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Ministry of Health
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Address [1]
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133 Molesworth Street
Thorndon
Wellington
6011
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Country [1]
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern Y ethics committee
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Ethics committee address [1]
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3rd floor, BNZ building
354 Victoria St
PO Box 1031
Hamilton
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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Approval date [1]
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11/08/2004
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Ethics approval number [1]
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WAI/04/05/044
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Summary
Brief summary
Project Energize is a programme that aims to reduce childhood obesity through a
range of school based interventions. It began in 2004, following a request for
proposals from the Waikato DHB introduced to about one quarter of Waikato children within selected schools and involved interventions to increase physical activity, decrease sedentary time and improve nutrition to ALL children in the school regardless of willingness to participate in the evaluation study.
The programme was evaluated by inviting children aged 5 and 10 years within the Project Energize schools” and within the same number of schools where there was no specific intervention (beyond standard / national initiatives) to participate in a longitudinal evaluation study. In 2004 and 2006 children had weight, height, blood pressure, upper arm and abdominal circumference and body fat measured; and the parent / caregiver answered a written questionnaire to determine whether this programme has any positive impact on weight gain, fitness, oral health, asthma, bone fractures and hypertension.
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Trial website
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Trial related presentations / publications
Graham D, Appleton S, Rush E, McLennan S, Reed P, Simmons D. Increasing activity and improving nutrition through a schools-based programme: Project Energize. 1. Design, programme, randomisation and evaluation methodology. Public Health Nutr. 2008:1-9.
Graham D, Appleton S, Rush E, McLennan S, Reed P, Simmons D. Increasing activity and improving nutrition through a schools-based programme: Project Energize. 1. Design, programme, randomisation and evaluation methodology. Public Health Nutr. 2008:1-9.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr David Graham
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Address
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Child Health, Waikato Hospital, PO Box 3200, Hamilton, New Zealand
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Country
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New Zealand
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Phone
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+6478398899
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor Elaine Rush
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Address
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AUT University
Private Bag 92006
Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 921 9999
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Fax
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Project Energize: intervention development and 10 years of progress in preventing childhood obesity
2016
https://doi.org/10.1186/s13104-016-1849-1
N.B. These documents automatically identified may not have been verified by the study sponsor.
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