ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000892213

Ethics application status

Approved

Date submitted

12/10/2009

Date registered

12/10/2009

Date last updated

9/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

‘Go for your life’ Health Promoting Communities: Being Active Eating Well

Scientific title

A quasi-experimental multi-level intervention demonstration project with comparison group to increase community capacity to promote healthy eating and physical activity, measured by changes in community capacity, environments, health behaviours and anthropometry.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

HPC: BAEW

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Overweight and obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention groups: multiple strategies in schools, workplaces and community organisations to promote healthy eating and physical activity. Examples of strategies include school and workplace food policies, community kitchens and gardens, walking groups, parent education programs, social marketing, training of local professionals and promoting active transport. The duration of the trial is approximately 4 years.

Intervention code [1]

Prevention

Comparator / control treatment

Comparison groups used in 5 of 6 projects. Comparison groups are exposed to any healthy eating and physical activities that may be occcuring coincidentally in the regions but no specific interventions will be instituted for this study.

Control group

Active

Outcomes

Primary outcome [1]

Body mass index z-score

Timepoint [1]

At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).

Secondary outcome [1]

Behavioural indicators of healthy eating and physical activity, measured by questionnaire.

Timepoint [1]

At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).

Secondary outcome [2]

Waist circumference

Timepoint [2]

At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).

Secondary outcome [3]

Body mass index

Timepoint [3]

At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).

Secondary outcome [4]

Prevalence of overweight and obesity, measured by body mass index and waist circumference.

Timepoint [4]

At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).

Secondary outcome [5]

School and workplace environmental changes, as measured by school/workplace environmental audits and expert assessment.

Timepoint [5]

At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).

Secondary outcome [6]

Community capacity to effect behaviour change around overweight and obesity, as evidenced by the development of new structures and partnerships, staff development, community awareness etc (measured by expert assessment).

Timepoint [6]

At baseline (2008-9) and follow up (2010). Evaluation of the program (and baseline data collection) began partway through the program (1-2 years from commencement of implementation).

Eligibility

Key inclusion criteria

Each project has a primary and secondary target group, with comparison groups selected to match primary targets. Target groups include children 0-12, adolescents 12-18, young people newly arrived to Australia, families, carers, working adults, older adults, seniors and an indigenous community.

Minimum age

No limit

Maximum age

No limit

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)

Allocation is not concealed

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

Other

Other design features

Intervention participants were non-randomly allocated to the intervention by school/workplace. Comparison schools and workplaces were randomly selected from the same community or matched areas of Victoria.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

4500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Health, Victoria

Address [1]

50 Lonsdale St
Melbourne Vic 3000

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Department of Planning and Community Development, Victoria

Address [2]

1 Spring St
Melbourne Vic 3000

Country [2]

Australia

Primary sponsor type

Government body

Name

Department of Health, Victoria

Address

50 Lonsdale St
Melbourne Vic 3000

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Department of Planning and Community Development, Victoria

Address [1]

1 Spring St
Melbourne Vic 3000

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Deakin University

Address [1]

Waterfront campus
1 Gheringhap St
Geelong, Victoria 3217

Country [1]

Australia

Other collaborator category [2]

Other Collaborative groups

Name [2]

Campaspe Primary Care Partnership

Address [2]

PO Box 164
Rochester Vic 3561

Country [2]

Australia

Other collaborator category [3]

Other Collaborative groups

Name [3]

Kingston Bayside Primary Care Partnership

Address [3]

Central Bayside CHS
335-337 Nepean Hwy
Parkdale Vic 3195

Country [3]

Australia

Other collaborator category [4]

Government body

Name [4]

City of Kingston

Address [4]

34 Brindisi St, Mentone
PO Box 1000
Mentone Vic 3194

Country [4]

Australia

Other collaborator category [5]

Other Collaborative groups

Name [5]

Southern Grampians & Glenelg Primary Care Partnership

Address [5]

Gray Street
Hamilton Vic 3300

Country [5]

Australia

Other collaborator category [6]

Other

Name [6]

Western District Health Service

Address [6]

Foster Street
Hamilton Vic 3300

Country [6]

Australia

Other collaborator category [7]

Other Collaborative groups

Name [7]

South East Health Communities Partnership

Address [7]

Level 2/15 Scott Street
Dandenong Vic 3175

Country [7]

Australia

Other collaborator category [8]

Government body

Name [8]

Cardinia Shire Council

Address [8]

PO Box 7
Pakenham Vic 3810

Country [8]

Australia

Other collaborator category [9]

Other Collaborative groups

Name [9]

Westbay Primary Care Partnership

Address [9]

PO Box 5102
Sunshine Vic 3020

Country [9]

Australia

Other collaborator category [10]

Other

Name [10]

Western Region Health Centre

Address [10]

72-79 Paisley St, Footscray 3011 (primary site)
and
107-139 Churchill Ave, Braybrook 3019 (for study coordinators)

Country [10]

Australia

Other collaborator category [11]

Charities/Societies/Foundations

Name [11]

Wathaurong Aboriginal Co-operative

Address [11]

Lot 62 Morgan St
North Geelong Vic 3215

Country [11]

Australia

Other collaborator category [12]

University

Name [12]

Royal Melbourne Institute of Technology (RMIT) University

Address [12]

Ballarat Road
Hamilton Vic 3300

Country [12]

Australia

Other collaborator category [13]

University

Name [13]

Monash University

Address [13]

PO Box 197
Caulfied East Vic 3145

Country [13]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee

Ethics committee address [1]

Deakin University, Burwood campus
221 Burwood Highway
Burwood, Vic 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/06/2008

Ethics approval number [1]

EC 98-2008

Ethics committee name [2]

Department of Human Services Human Research Ethics Committee

Ethics committee address [2]

50 Lonsdale St
Melbourne Vic 3000

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

University of Melbourne HREC

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

04/05/2009

Ethics approval number [3]

0931490.1

Summary

Brief summary

'Go for your life' Health Promoting Communities: Being Active Eating Well (HPC: BAEW) is a community-based intervention program aimed at increasing the community’s capacity to promote healthy eating and physical activity and to reduce unhealthy weight gain across the community.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Rebecca Doherty

Address

Department of Health
50 Lonsdale St
Melbourne Vic 3000

Country

Australia

Phone

+61 3 9096 2211

Fax

Email

[email protected]

Contact person for scientific queries

Name

Dr Michelle Haby

Address

Department of Health
50 Lonsdale St
Melbourne Vic 3000

Country

Australia

Phone

+61 3 9096 5829

Fax

Email

[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

Source	Title	Year of Publication	DOI
Embase	The effect of gender and age on the association between weight status and health-related quality of life in Australian adolescents.	2014	https://dx.doi.org/10.1186/1471-2458-14-898

N.B. These documents automatically identified may not have been verified by the study sponsor.