Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000614099
Ethics application status
Approved
Date submitted
27/07/2010
Date registered
28/07/2010
Date last updated
15/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Living 4 Life - A school-based obesity prevention study in secondary schools
Scientific title
A 3 year study in secondary school students of a multi-component intervention to improve eating and activity behaviours compared to no specific interventions on changes in body size and composition
Secondary ID [1] 252298 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adolescent overweight and obesity 257813 0
Condition category
Condition code
Diet and Nutrition 257984 257984 0 0
Obesity
Public Health 258001 258001 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions are delivered primarily in schools and are developed in coordination with Student Health Councils. Interventions aim to promote healthy eating and increase physical activity before, during and after school. Interventions such as school policies and improvements to the physical environment at school (e.g. school canteen, water fountains, sporting equipment) also implemented.

The main intervention activity is in the development of the student Health Councils so that the students can design and develop interventions that are acceptable and appropriate for their school. For example, Student Health Councils are supported to initiate and administer breakfast clubs, lunchtime activities, and health promotions in their schools. The Student Health Councils meet weekly throughout the intervention (3 years) .
Intervention code [1] 256876 0
Prevention
Intervention code [2] 256892 0
Other interventions
Comparator / control treatment
Comparison group is exposed to background activities in the region with no specific intervention activities initiated. For example, schools in the comparison group may be involved with regional providers that deliver activity sessions in schools or may initiate their own school food policies.
Control group
Active

Outcomes
Primary outcome [1] 258848 0
Percent body fat will be measured using the Tanita BC-418 body composition analyser.
Timepoint [1] 258848 0
Measured at baseline (2005) and at follow up (2008 or before as student leaves school)
Secondary outcome [1] 264968 0
Body mass index, body mass index z-score, prevalence of overweight and obesity will be measured using digital scales and portable stadiometers by trained research staff.
Timepoint [1] 264968 0
All will be measured at baseline (2005) and at follow up (2008 or before as student leaves school).
Secondary outcome [2] 264986 0
Behavioural indicators of healthy eating and physical activity will be assessed with survey instruments administered on handheld computers.
Timepoint [2] 264986 0
All will be measured at baseline (2005) and at follow up (2008 or before as student leaves school).
Secondary outcome [3] 264987 0
Quality of Life will be measured with two validated Quality of Life instruments as part of the survey instrument
Timepoint [3] 264987 0
All will be measured at baseline (2005) and at follow up (2008 or before as student leaves school).

Eligibility
Key inclusion criteria
All students attending selected schools in intervention and control areas.
Minimum age
12 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

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
Completed
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment outside Australia
Country [1] 2784 0
New Zealand
State/province [1] 2784 0

Funding & Sponsors
Funding source category [1] 257339 0
Government body
Name [1] 257339 0
Health Research Council (NZ)
Country [1] 257339 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
School of Population Health
University of Auckland
Private Bag 92019
Auckland
New Zealand
1142
Country
New Zealand
Secondary sponsor category [1] 256579 0
University
Name [1] 256579 0
Deakin University
Address [1] 256579 0
Deakin University
221 Burwood Highway
Melbourne VIC 3125
Country [1] 256579 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259370 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 259370 0
Ethics committee country [1] 259370 0
New Zealand
Date submitted for ethics approval [1] 259370 0
Approval date [1] 259370 0
02/12/2004
Ethics approval number [1] 259370 0
2004/249

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

Contacts
Principal investigator
Name 31434 0
Address 31434 0
Country 31434 0
Phone 31434 0
Fax 31434 0
Email 31434 0
Contact person for public queries
Name 14681 0
Robert Scragg
Address 14681 0
School of Population Health
University of Auckland
Private Bag 92019
Auckland
1142
Country 14681 0
New Zealand
Phone 14681 0
+6493737599
Fax 14681 0
Email 14681 0
[email protected]
Contact person for scientific queries
Name 5609 0
Robert Scragg
Address 5609 0
School of Population Health
University of Auckland
Private Bag 92019
Auckland
1142
Country 5609 0
New Zealand
Phone 5609 0
+6493737599
Fax 5609 0
Email 5609 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.