Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000388213
Ethics application status
Approved
Date submitted
13/05/2009
Date registered
29/05/2009
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Are self management programs feasible in worksites in rural Western Australia?
Scientific title
Rural forestry workers self management intervention to adopt healthy lifestyles to reduce the risk of developing chronic disease.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventing chronic disease 4765 0
Chronic disease 4774 0
Condition category
Condition code
Public Health 237105 237105 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed study will be delivered in 4 phases to coincide with the 3 levels of the intervention with a fourth phase to explore the stages of change:
Phase I- This phase includes the delivery of educational presentations on nutrition, exercise and other health life style habits. These educational sessions will be presented in the workplace to encourage participation. The 3 sessions will each take approximatly 30 minutes and will be hld one per month, therefore taking approximately 3 months.
Phase II- The second phase includes monthly monitoring Body Mass Index (BMI) competitions. Once a month participants will be weighed and measured. These measurements will be recorded and used as the outcome measure. A competition will be established between organisations to compare the proportion of the “team” decreasing in body mass index (BMI) and will last about 12 months.
Phase III- The third phase involves a lifestyle coaching program. This will consist of a weight loss program tailored to the needs of participants and will be monitored at regular intervals through routine follow-up with a lifestyle coach (four session over approximately 6 months).
Phase IV-The fourth phase includes individual interviews with participants to evaluate the intervention and to explore in depth the stages of change experienced during the program. The interviews will be held participants post program completion (one interview per participant) and will last approximately 30 minutes.
Intervention code [1] 4544 0
Lifestyle
Comparator / control treatment
A comparison group is included in the third phase of the project, the lifestyle coaching. Participants in the lifestyle coaching program will be compared to non-participants who remain only in phase two: the Body Mass Index competition. The comparion group will go through all phases EXCEPT phase three. As phase four is only an evaluation phase the comparion group are not exposed to any further intervention following phase two. This study is not suitable as a cross over trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5935 0
Reduction in body mass index measured in kg/m2. This will be measured by height (measured with a standard height measuring device) and weight (measured with electronic scales) measurements. These measurements will be taken at baseline then monthly for the duration of the intervention.
Timepoint [1] 5935 0
Baseline, then monthly for duration of the intervention
Secondary outcome [1] 242030 0
Adopting healthy diet and excercise patterns, measured by self report well validated tools. Diet: Wright and Scott's (2000) Fat and Fibre Barometer.
Activity: Active Australia Survey.
Timepoint [1] 242030 0
Survey will be completed at four timepoints.
(T1), post- education/pre-body mass index competition (T2), mid- body mass index competition/pre-lifestyle coaching (T3) and post project implementation (T4).

Eligibility
Key inclusion criteria
The inclusion criteria will be:
1. Living in the Great South region of Western Australia (WA),
2. Employed in one of 5 selected forestry organisations
3. Males of working age (35-65 years),
4.Can read and speak English i.e., they do not need an interpreter.
Phase three of the intervention will include a purposeful sample from phase two participants and will have a specific inclusion criteria including:
5. Having a BMI =27,
6. Being in preparation stages of change.
Phase four of the study will include participants selected from phase two and three.
Minimum age
35 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study under the following conditions:
1. Assessed as unsafe to participate by a health professional,
2. Healthy weight of BMI = 25.

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4956 0
University
Name [1] 4956 0
Curtin University of Technology- Australian Post graduate Award and Curtin Research Scholarship
Country [1] 4956 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 4559 0
None
Name [1] 4559 0
Address [1] 4559 0
Country [1] 4559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239145 0
Curtin University of Technology Human Research Ethics Committee
Ethics committee address [1] 239145 0
Ethics committee country [1] 239145 0
Australia
Date submitted for ethics approval [1] 239145 0
15/03/2009
Approval date [1] 239145 0
20/05/2009
Ethics approval number [1] 239145 0
HR 24/2009

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

Contacts
Principal investigator
Name 29599 0
Address 29599 0
Country 29599 0
Phone 29599 0
Fax 29599 0
Email 29599 0
Contact person for public queries
Name 12846 0
Kristi Holloway
Address 12846 0
Curtin University of Technology
Westrern Australian Centre for Cancer and Palliative Care
GPO Box U1987
Perth WA 6845
Country 12846 0
Australia
Phone 12846 0
+618 92661766
Fax 12846 0
Email 12846 0
[email protected]
Contact person for scientific queries
Name 3774 0
Professor Samar Aoun
Address 3774 0
Curtin University of Technology
Westrern Australian Centre for Cancer and Palliative Care
GPO Box U1987
Perth WA 6845
Country 3774 0
Australia
Phone 3774 0
+618 92661766
Fax 3774 0
Email 3774 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.