Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000346370
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
Ma'alahi Youth Project; The effects of a community based intervention promoting healthy eating and physical activity in secondary school students on changes in body size and composition.
Scientific title
A 3-year study in secondary school children of a multi-strategy, community driven 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 2755 0
Obesity 2756 0
Condition category
Condition code
Public Health 2882 2882 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions are multiple strategies over 3 years within the communities and selected schools to build the community's capacity to promote healthy eating and physical activity. The promotional strategies are implemented by the Obesity Prevention In Community (OPIC) Intervention Officers and National Health Promotion Officers from the Ministry of Health. Promotional materials used are social marketing (e.g. Billboards, radio programmes, Radio and TV spots), community based sports competition, leaflet distribution on importance / composition of healthy breakfast, helping in the set up of vegetable gardens through seedling distribution and implementing the National Canteen Guidelines in school canteens. Aerobics sessions and competitions are also promoted both in schools and village communities.
Intervention code [1] 2494 0
Prevention
Comparator / control treatment
Comparative group is not exposed to specific intervention strategies instituted but involved in the general national health promotion programs.
Control group
Active

Outcomes
Primary outcome [1] 3767 0
Percent body fat using the Tanita Body Analyser.
Timepoint [1] 3767 0
Baseline Study: 2005
Follow-up Study: 2008
Secondary outcome [1] 6358 0
Prevalence of overweight and obesity assessed by waist circumference,
Timepoint [1] 6358 0
Baseline Study: 2005
Follow-up Study: 2008
Secondary outcome [2] 6359 0
Quality of life measured by the modified Assessment of Quality of Life (AQoL) tool.
Timepoint [2] 6359 0
Baseline Study: 2005
Follow-up Study: 2008
Secondary outcome [3] 7176 0
Body mass index measured by body mass index z-score
Timepoint [3] 7176 0
Baseline Study: 2005
Follow-up Study: 2008

Eligibility
Key inclusion criteria
Inclusion for measurement: male and female students in Forms 1-6 in selected schools in intervention and comparison areas.
Inclusion Criteria for schools and communities: Sample size of students and convenience and relevance of location.
Minimum age
11 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age of student (between 12 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
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment outside Australia
Country [1] 753 0
Tonga
State/province [1] 753 0

Funding & Sponsors
Funding source category [1] 3009 0
Charities/Societies/Foundations
Name [1] 3009 0
Wellcome Trust
Country [1] 3009 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] 2712 0
Government body
Name [1] 2712 0
Tonga Ministry of Health
Address [1] 2712 0
Tonga Medical Association Building
Vaiola Hospital
Havelu
Nuku'alofa
Tonga
Country [1] 2712 0
Tonga
Secondary sponsor category [2] 2713 0
University
Name [2] 2713 0
Fiji School of Medicine
Address [2] 2713 0
Hoodless House
Brown Street
Suva
Country [2] 2713 0
Fiji

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4967 0
Tonga Ministry of Health Research Ethics Committee
Ethics committee address [1] 4967 0
Tonga Medical Association Building
Vaiola Hospital
Havelu
Nuku'alofa
Tonga
Ethics committee country [1] 4967 0
Tonga
Date submitted for ethics approval [1] 4967 0
Approval date [1] 4967 0
Ethics approval number [1] 4967 0

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

Contacts
Principal investigator
Name 28323 0
Address 28323 0
Country 28323 0
Phone 28323 0
Fax 28323 0
Email 28323 0
Contact person for public queries
Name 11480 0
Tilema Cama
Address 11480 0
Tonga Medical Association Building
Vaiola Hospital
Havelu
Nuku'alofa
Tonga
Country 11480 0
Tonga
Phone 11480 0
676 28584
Fax 11480 0
676 27941
Email 11480 0
[email protected]
Contact person for scientific queries
Name 2408 0
Professor Graham Roberts
Address 2408 0
Research Department
Hoodless House
Fiji School of Medicine
Brown Street
Suva
Country 2408 0
Fiji
Phone 2408 0
679 323 3404
Fax 2408 0
679 331 1940
Email 2408 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.