Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000345381
Ethics application status
Approved
Date submitted
23/01/2008
Date registered
22/07/2008
Date last updated
22/07/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Youths, Healthy Communities; A community based obesity prevention study in secondary school students.
Scientific title
A 3-year study in secondary school children of a multi-strategy, community intervention promoting healthy eating and physical activity compared to no specific interventions on changes in body size and composition.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent overweight 2752 0
Obesity 2753 0
Condition category
Condition code
Public Health 2880 2880 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions are multiple strategies over 3 years within secondary schools and the community to build the community's capacity to promote healthy eating and physical activity. Examples include school food policies, improving school food service, within school and after school physical activity programs, training of teachers, students and community leaders as coordinators, curriculum on healthy eating and physical activities, social marketing, incorporating programs into local government strategic plans.
Intervention code [1] 2493 0
Prevention
Comparator / control treatment
Comparison group is only exposed to promotional activities by the National Health Promotion Centre with no specific intervention strategies instituted by the Obesity Prevention In Communities (OPIC) Project.
Control group
Active

Outcomes
Primary outcome [1] 3764 0
Percent body fat using the Tanita Body Analyser.
Timepoint [1] 3764 0
Baseline Study:2005
Follow-up Study: 2008 or before as student leaves school.
Secondary outcome [1] 6356 0
Prevalence of overweight and obesity assessed by waist circumference.
Timepoint [1] 6356 0
Baseline Study: 2005
Follow-up Study: 2008
Secondary outcome [2] 6357 0
Quality of life measured using the modified AQol tool.
Timepoint [2] 6357 0
Baseline Study: 2005
Follow-up Study: 2008
Secondary outcome [3] 7175 0
Body mass index measured by body mass index z-score.
Timepoint [3] 7175 0
Baseline Study: 2005
Follow-up Study: 2008

Eligibility
Key inclusion criteria
Inclusion for measurement: male and female students in Forms 3-6 in selected schools in intervention and comparison areas. Minimum age: 12 years, maximum age: 19 years.
Inclusion Criteria of schools and community: sample size and ethnic composition, convenience and relevance of location.
Minimum age
13 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age of student (between 13 years to 19 years)

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 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6000
Accrual to date
Final
Recruitment outside Australia
Country [1] 752 0
Fiji
State/province [1] 752 0
Naitasiri

Funding & Sponsors
Funding source category [1] 3007 0
Charities/Societies/Foundations
Name [1] 3007 0
Wellcome Trust
Country [1] 3007 0
United Kingdom
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Country
Australia
Secondary sponsor category [1] 2710 0
Government body
Name [1] 2710 0
Fiji Ministry of Health
Address [1] 2710 0
Dinem House
Suva
Fiji Islands
Country [1] 2710 0
Fiji
Secondary sponsor category [2] 2711 0
University
Name [2] 2711 0
Fiji School of Medicine
Address [2] 2711 0
Hoodless House
Brown Street
Suva
Country [2] 2711 0
Fiji

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4965 0
Fiji National Research Ethics Review Committee
Ethics committee address [1] 4965 0
Ministry of Health
Dinem House
Suva
Ethics committee country [1] 4965 0
Fiji
Date submitted for ethics approval [1] 4965 0
01/01/2004
Approval date [1] 4965 0
01/01/2004
Ethics approval number [1] 4965 0
009-2004

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

Contacts
Principal investigator
Name 28322 0
Address 28322 0
Country 28322 0
Phone 28322 0
Fax 28322 0
Email 28322 0
Contact person for public queries
Name 11479 0
Gade Waqa
Address 11479 0
TROPIC Building
Tamavua Campus
Rrincess Road
Fiji School of Medicine
Tamavua
Suva
Country 11479 0
Fiji
Phone 11479 0
679 323 3254
Fax 11479 0
679 331 1940
Email 11479 0
g.waqa@fsm.ac.fj
Contact person for scientific queries
Name 2407 0
Professor Graham Roberts
Address 2407 0
Research Department
Hoodless House
Fiji School of Medicine
Brown Street
Suva
Country 2407 0
Fiji
Phone 2407 0
679 323 3404
Fax 2407 0
679 331 1940
Email 2407 0
g.roberts@fsm.ac.fj

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
EmbaseThe cross-sectional association between diet quality and depressive symptomology amongst Fijian adolescents.2016https://dx.doi.org/10.1371/journal.pone.0161709
N.B. These documents automatically identified may not have been verified by the study sponsor.