Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 280088 0
NIL
Universal Trial Number (UTN)
U1111-1128-9486
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 285999 0
Poor nutrition 286000 0
Sedentry lifestyle behaviours 286001 0
Mental well-being 286002 0
Condition category
Condition code
Diet and Nutrition 286185 286185 0 0
Obesity
Mental Health 286186 286186 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 286187 286187 0 0
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] 284413 0
Prevention
Intervention code [2] 284414 0
Lifestyle
Intervention code [3] 284415 0
Behaviour
Comparator / control treatment
No comparison group. Measuring outcomes of the intervention group only.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286657 0
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] 286657 0
at one year after intervention commencement
Primary outcome [2] 286658 0
Demonstrate an increased up take in regular exercise. Outcomes will be assessed by yarning groups, individual interviews, participant observation and direct observation.
Timepoint [2] 286658 0
at one year after intervention commencement
Primary outcome [3] 286659 0
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] 286659 0
at one year after intervention commencement
Secondary outcome [1] 296401 0
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] 296401 0
at 6 months after intervention commencement
Secondary outcome [2] 296402 0
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] 296402 0
at 3 month intervals over the 1 year intervention period
Secondary outcome [3] 296403 0
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] 296403 0
at 3 month intervals over the 1 year intervention period
Secondary outcome [4] 296404 0
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] 296404 0
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
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284844 0
Self funded/Unfunded
Name [1] 284844 0
Country [1] 284844 0
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] 283722 0
Individual
Name [1] 283722 0
Associate Professor Catherine Fetherston
Address [1] 283722 0
Murdoch University Peel Campus
Education Drive
Mandurah
Western Australia 6210
Country [1] 283722 0
Australia
Other collaborator category [1] 260605 0
Individual
Name [1] 260605 0
Mrs Caroline Nilson
Address [1] 260605 0
Murdoch University Peel Campus
Education Drive
Mandurah
Western Australia 6210
Country [1] 260605 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286835 0
Ethics committee address [1] 286835 0
Ethics committee country [1] 286835 0
Date submitted for ethics approval [1] 286835 0
16/03/2012
Approval date [1] 286835 0
Ethics approval number [1] 286835 0

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 33878 0
Address 33878 0
Country 33878 0
Phone 33878 0
Fax 33878 0
Email 33878 0
Contact person for public queries
Name 17125 0
Mrs Caroline Nilson
Address 17125 0
Murdoch University Peel Campus
Education Drive
Mandurah
Western Australia 6210
Country 17125 0
Australia
Phone 17125 0
+61 8 95825509
Fax 17125 0
+61 8 95825515
Email 17125 0
c.nilson@murdoch.edu.au
Contact person for scientific queries
Name 8053 0
Professor Paul Morrison
Address 8053 0
Murdoch University Peel Campus
Education Drive
Mandurah
Western Australia 6210
Country 8053 0
Australia
Phone 8053 0
+61 8 95825502
Fax 8053 0
+61 8 95825515
Email 8053 0
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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn 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.2015https://dx.doi.org/10.1017/S1368980015000816
N.B. These documents automatically identified may not have been verified by the study sponsor.