ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000292875

Ethics application status

Not yet submitted

Date submitted

7/03/2012

Date registered

13/03/2012

Date last updated

13/03/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

Bindjareb Yorgas Health Program: Improving the Health of Women and Families

Scientific title

A partnership with Bindjareb Nyungar women in Pinjarra aimed at developing the Bindjareb Yorgas Health Program; a sustainable suite of health promotion activities aimed at establishing health literacy, self-determination and individual, social and community capacity.

Secondary ID [1]

NIL

Universal Trial Number (UTN)

U1111-1128-9486

Trial acronym

Linked study record

Health condition

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

Obesity

Poor nutrition

Sedentry lifestyle behaviours

Mental well-being

Condition category

Condition code

Diet and Nutrition

Obesity

Mental Health

Studies of normal psychology, cognitive function and behaviour

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All participants will receive one intervention. The intervention is a suite of health promotion activities. All participants will be involved in all of the activities over the single I year trial duration. The intervention will take place during the school terms in the Mother of All Sheds (MOASH) building, a community centre provided by the CDF and, situated on the grounds of the Pinjarra Primary School.
The intervention activities in which all participants will be involved in are:
Group Fitness: Conducted for 1 hour 3 times per week for the single 1 year trial duration (not including school holidays). All participants will engage in activities designed to improve cardiovascular fitness, aerobic fitness, core strength and flexibility and to promote wellbeing. These sessions will be conducted by a qualified group fitness instructor.
Nutrition classes: Conducted once a fortnight for three hours for the single 1 year trial duration (not including school holidays). All participants will engage in activities designed to improve skills in safe food handling and storage, safe food preparation, healthy food purchasing and meal planning on a budget and to develop knowledge in nutritional value of foods to maintain wellbeing and good health. These sessions will be conducted by a qualified cooking class instructor.
Yarning groups: Conducted once a fortnight for the single 1 year trial duration (not including school holidays). All participants will engage in knowledge sharing (Nyungar lore) facilitated by Nyungar Elders. Nyungar lore is the body of knowledge or kaartdijin in oral tradition and observed in the customs, rituals and behaviours of Nyungar people. During these sessions Nyungar Elders will share a set of lore and customs relating to marriage, food, all aspects of womanhood, land ownership and access. Guest speakers and professional will also contribute to information sharing. These sessions will be supervised by an Aboriginal Health Worker.
Community vegetable garden: Established by the participants to aid in the provision of fresh produce for the nutrition classes and to aid in food security for the participants and their families. The garden will be tended by the participants for at least 2 - 2.5 hours per week over the total duration of 1 year. This will be supervised by the research assistant who is a Bindjareb community Leader.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

No comparison group. Measuring outcomes of the intervention group only.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Demonstrate increased nutritional knowledge, safe food handling, preparation and storage and healthy meal planning and delivery.
Outcomes will be assessed by yarning groups, individual interviews, participant observation and direct observation.

Timepoint [1]

at one year after intervention commencement

Primary outcome [2]

Demonstrate an increased up take in regular exercise. Outcomes will be assessed by yarning groups, individual interviews, participant observation and direct observation.

Timepoint [2]

at one year after intervention commencement

Primary outcome [3]

Demonstrate knowledge gained in a wide range of health topics, through modelling improved health behaviours.
Outcomes will be assessed by yarning groups, individual interviews, participant observation and direct observation.

Timepoint [3]

at one year after intervention commencement

Secondary outcome [1]

Health parameters such as blood pressure, weight, waist measurements and body fat will be either within normal range or showing a reduction from pre-intervention measurement.
Outcomes will be measured by collecting objective data using the following medical equipment:
- Scales for weight
- Sphygmomanometer and stethoscope for blood pressure
- Tape measure for waist measurements
- Calipers for body fat composition

Timepoint [1]

at 6 months after intervention commencement

Secondary outcome [2]

Developed self-determination to community capacity by a willingness to contribute to the maintenance and sustainability of the program verbalised through yarning sessions using semistructured interviews, group sessions and observed through participant observation

Timepoint [2]

at 3 month intervals over the 1 year intervention period

Secondary outcome [3]

Developed awareness of and connection with the importance of a balance of new and cultural knowledge verbalised through yarning sessions using semistructured interviews, group sessions and observed through participant observation

Timepoint [3]

at 3 month intervals over the 1 year intervention period

Secondary outcome [4]

Knowledge regarding vegetable growing evidenced by continued participation in the community garden project verbalised through yarning sessions using semistructured interviews, group sessions and observed through participant observation

Timepoint [4]

at 3 month intervals over the 1 year intervention period

Eligibility

Key inclusion criteria

Bindjareb Nyungar women from the two kinship groups in Pinjarra, Western Australia.

Participants who have undergone a pre-screening test prior to their involvement in the fitness sessions of the program.

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Nil

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

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/11/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Professor Paul Morrison

Address

Murdoch University Peel Campus
Education Drive
Mandurah
Western Australia 6210

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Associate Professor Catherine Fetherston

Address [1]

Murdoch University Peel Campus
Education Drive
Mandurah
Western Australia 6210

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Mrs Caroline Nilson

Address [1]

Murdoch University Peel Campus
Education Drive
Mandurah
Western Australia 6210

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

16/03/2012

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Context: The Bindjareb Yorgas Health Program (BYHP) project addresses the high prevalence of health issues experienced by Aboriginal women and their families (Thomson et al., 2010) through the establishment of a holistic community owned and developed health and wellness program. The BYHP is being developed at the request of the Bindjareb women from the Murray District Aboriginal Association in Pinjarra, following the success of a 2011 seed project, “The Deadly Koolinga Chefs” (DKC). The DKC program was conducted by the study’s PhD student and funded by the Community Development Foundation (CDF). The project engaged a group of 12 year old Bindjareb children in a 12 week nutrition and cooking adventure, where they learned how to plan, shop for and prepare a healthy meal for four. Each week the children took home their prepared meals, together with their new skills and knowledge, to share with their family. This resulted in a request by the Bindjareb women for a broader health promotion program to address the health and wellbeing of the community’s women and by association, their families. In collaboration with the Bindjareb women, using an aboriginal approach based on “unity’ and “wholeness” (Wingard & Lester, 2001) a suite of programs is being developed (see Appendix A). The BYHP, for which Healthway funding is being sought, is the first of these to be undertaken and comprises four components: group fitness and exercise sessions; nutrition education and cooking classes; vegetable growing and Nyungar lore, communicated through Kaartdijin yarning sessions. This combination was agreed upon as it specifically addressed the Bindjareb women’s concerns regarding the need for a more culturally appropriate approach to health promotion to address health issues being experienced in their community.
Objectives: This intervention aims to extend knowledge surrounding existing health promotion initiatives previously designed in Aboriginal communities by implementing a program that ensures community ownership and development of the program. It will focus specifically on three action areas for undertaking health promotion: creating supportive environments to encourage equitable access; strengthening community actions to enable empowerment; and the development of personal skills in achieving and maintaining wellness. 
Methods: The intervention has been developed using a multi-faceted approach to promoting healthy eating and improved fitness within the context of Nyungar lore. To ensure a culturally appropriate means, of assessing the outcomes, a holistic descriptive case study method (Yin, 2009) will be used, where the researchers will seek to narratively explore the impact on participant’s health behaviours in relation to the development of, and participation in, the BYHP. The data will be collected with the assistance of the Aboriginal Health Worker (AHW) and the Aboriginal Research Associate (RA). Data sources will therefore include yarning groups, interviews, direct observations and participant-observations and will be collected over the course of the intervention and the year to follow.  The program will take place during the school terms in the Mother of All Sheds (MOASH) building, a community centre provided by the CDF and, situated on the grounds of the Pinjarra Primary School.  
Expected benefits: This intervention project, whilst facilitating community ownership and leadership of an Aboriginal health promotion program aims to provide both short and long term improvements in the physical activity and healthy eating habits that will translate into improved fitness and weight loss, and empowerment through increased health knowledge. These have important implications for the health and well-being and the social and community capacity of the Bindjareb community in Pinjarra and may also serve as a template for similar health promotion programs in other communities. In addition, identifying environments that encourage Aboriginal participation and are nurturing to both attitudes and aptitudes of good health behaviours may have positive implications on future policy development and infrastructure planning related to Aboriginal health.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Mrs Caroline Nilson

Address

Murdoch University Peel Campus
Education Drive
Mandurah
Western Australia 6210

Country

Australia

Phone

+61 8 95825509

Fax

+61 8 95825515

c.nilson@murdoch.edu.au

Contact person for scientific queries

Name

Professor Paul Morrison

Address

Murdoch University Peel Campus
Education Drive
Mandurah
Western Australia 6210

Country

Australia

Phone

+61 8 95825502

Fax

+61 8 95825515

p.morrison@murdoch.edu.au

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

Type	Is Peer Reviewed?	Citations or Other Details
Other files	No	Nilson, C., Morrison, P., Fetherston, C., & Kearin... [More Details]
Study results article	Yes	Nilson, C., Morrison, P., Fetherston, C., & Kearin... [More Details]
Study results article	Yes	Nilson, C. (2016). A journey toward cultural compe... [More Details]
Study results article	Yes	Nilson, C., Morrison, P., and Fetherston, C. (2016... [More Details]
Study results article	Yes	Nilson, C., Kearing Salmon, K., Morrison, P., and ... [More Details]
Study results article	Yes	Nilson, C., Kearing, G., Fetherston, C., & Morriso... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	An ethnographic action research study to investigate the experiences of Bindjareb women participating in the cooking and nutrition component of an Aboriginal health promotion programme in regional Western Australia.	2015	https://dx.doi.org/10.1017/S1368980015000816

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

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Documents added automatically