Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000497404
Ethics application status
Approved
Date submitted
15/03/2016
Date registered
18/04/2016
Date last updated
18/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
An 8-week physical activity intervention for Australian Indigenous adults to improve their functional capacity.
Scientific title
A pragmatic trial of an 8-week physical activity program for Australian Indigenous adults with/ or at risk of chronic disease, to improve functional capacity.
Secondary ID [1] 288397 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic disease 297402 0
physical inactivity 297403 0
Functional capacity 297404 0
Condition category
Condition code
Public Health 297593 297593 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention(s) / exposure: The aim of this study is to evaluate a culturally tailored 8 week physical activity intervention among Aboriginal and Torres Strait Islander adults in rural communities. The objectives will be to measure overall levels of physical activity and step counts, metabolic markers, perceived quality of life and other health behaviours and outcomes before, immediately after and 12 weeks after the intervention. The program will be delivered through one-hour, face-to-face group sessions, four times per week for eight weeks. Two of the weekly session will moderate intensity sessions, will be delivered with the assistance of the principal investigator who is a qualified Sport and Exercise Scientist. The moderate intensity session will include circuit training and team sports, with adaptations made to incorporate individual fitness levels. The remaining two sessions will self-paced low intensity walking sessions (male and female groups) will be conducted by community leaders. Involving community leaders is important to assist with the eventual changeover and sustainability of the program. Moderate and low intensity will be alternated during the intervention period. Each session will have a sign in sheet to monitor the program dose responses and implementation fidelity. The activities will be conducted at free community facilities such as walking tracks and football fields so there is no cost to participants. A cost benefit analysis will be conducted to determine if the project was 'value for money'. A focus group will be conducted after the intervention to explore participants’ experiences with the program and suggestions for future programs.
Intervention code [1] 293705 0
Prevention
Intervention code [2] 293706 0
Lifestyle
Intervention code [3] 293707 0
Treatment: Other
Comparator / control treatment
The study will consist of an intervention group and a wait-listed controlled group. Both groups will receive an 8 week physical activity program. The control group will receive the physical activity program immediately after the intervention group have completed the post program data collection.
Control group
Active

Outcomes
Primary outcome [1] 297136 0
Functional capacity, assessed by the six-minute walk test
Timepoint [1] 297136 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [1] 320131 0
Step count, assessed by a Fitbit Flex
Timepoint [1] 320131 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [2] 320132 0
Quality of life, assessed by the SF12
Timepoint [2] 320132 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [3] 322700 0
Blood pressure, measured using an electronic monitor
Timepoint [3] 322700 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [4] 322701 0
Weight and body fat, assessed using a segmental bioelectrical impedance Tanita body fat monitor/scale, (BF-545, Tanita Corporation, Tokyo, Japan).
Timepoint [4] 322701 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [5] 322704 0
Waist and hip circumference, measured to the nearest 0.1cm.
Timepoint [5] 322704 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [6] 322708 0
Fasting blood glucose levels will be analysed using Hexokinase BSL: Abbott c16000 (Hexokinase – enzymatic)
Timepoint [6] 322708 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [7] 322709 0
Premedical and lifestyle questionnaire:
The pre medical questionnaire includes questions about participants’ current state of health such as illness and injuries, family medical history, their own medical history and if they had been told not to participate in exercise. We have added questions on socio-economic status, education level and number of dependent children in the household. Health behaviour questions, such as fruit and vegetable and alcohol intake, were taken from national surveys such as the National Aboriginal and Torres Strait Islander Nutrition and Physical Activity Survey 2012-13 and the 2013 National Drug Strategy Household Survey. The survey questions will allow for more comparable results for the community data against national averages.
Timepoint [7] 322709 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [8] 322897 0
HbA1C will be analysed using Biorad D-100 (HPLC Ion Exchange).
Timepoint [8] 322897 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [9] 322898 0
Liver function will be analysed using Abbott c16000 (Enzymatic/colorimetric).
Timepoint [9] 322898 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [10] 322899 0
Total cholesterol (LDL, HDL) will be analysed using Abbott c16000 (Enzymatic/colorimetric).
Timepoint [10] 322899 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [11] 322900 0
Triglycerides will be analysed using Abbott c16000 (Enzymatic/colorimetric).
Timepoint [11] 322900 0
Baseline, immediately post intervention and three months after the intervention.
Secondary outcome [12] 322901 0
C-reactive protein will be analysed using Abbott c16000 (Immunoturbidimetric).
Timepoint [12] 322901 0
Baseline, immediately post intervention and three months after the intervention.

Eligibility
Key inclusion criteria
The sampling frame is Aboriginal and Torres Strait Islanders aged 18-45 years old who have a chronic disease or a risk factor for chronic disease and are residing in the communities of interest. Risk factors for chronic diseases are based on the definitions by the Australian Institute of Health and Welfare guidelines, such as having a BMI of/or greater than 30, waist circumference of/or greater than 94 centimetres for men and 80 centimetres for women and less than 150minutes of physical activity per week.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are pregnant or have been advised not to exercise by a medical professional.

Study design
Purpose of the study
Treatment
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
The intervention is an 8-week physical activity program to be conducted in two Indigenous communities using a pragmatic study design. This intervention is considered a ‘complex intervention’ due to the large number of discretionary behaviours and actions required between the sites. Flexibility and tailoring of the program in the delivery and reception will be important factors for success. During discussions with the Indigenous mentors, it was agreed between the participating communities that an appropriate way to standardise the intervention would be through the number of sessions and the intensity. There will be four physical activity sessions per week, two with low intensity and two with a moderate intensity. The choice of activities will depend on what is most appropriate for the community and for the participants.
Phase
Type of endpoint/s
Statistical methods / analysis
Although this is a non-randomised controlled trial statistical analysis and reporting will follow the SPIRIT guidelines. Participants’ characteristics including the outcome measures of the intervention and control communities will be compared at baseline to detect any potential confounding variables. Numerical data will be compared using a Student’s t-test if symmetrical and Mann-Wilcoxon test is skewed; and categorical data will be compared using Chi-squared tests.

The main outcome measure is the difference in the distance walked in the six minute walk test. Potential confounding will be further investigated using Analysis of Covariance. If the main outcome measure is not fitting assumptions of normality, it will be log transformed for the multivariate analysis. Further, multiple linear regression analyses will be used to examine associations between health behavioural variables and differences in the distance in the six minute walk test.

Statistical significance will be assumed when p-values are less than 0.05.The statistical analyses will be undertaken using Stata 13.

The group sample size of 42 per community is estimated to achieve 81% power to detect a significant difference in six-minute walk test distance at a p-value of 0.05, on the assumptions participants will increase their walking distance by 50 metres. An additional 8 participants per group will be included to account for attrition, making the total sample of 50 participants per community.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 12578 0
4860 - Innisfail
Recruitment postcode(s) [2] 12579 0
4873 - Mossman Gorge

Funding & Sponsors
Funding source category [1] 292895 0
Charities/Societies/Foundations
Name [1] 292895 0
Far North Queensland Hospital Foundation
Country [1] 292895 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
14-88 McGregor Rd,
Smithfield, Queensland, Australia
4878
Country
Australia
Secondary sponsor category [1] 291639 0
None
Name [1] 291639 0
Address [1] 291639 0
Country [1] 291639 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294237 0
James Cook University Human Research Ethics Committee
Ethics committee address [1] 294237 0
Ethics committee country [1] 294237 0
Australia
Date submitted for ethics approval [1] 294237 0
29/10/2014
Approval date [1] 294237 0
12/11/2014
Ethics approval number [1] 294237 0
H5942

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

Contacts
Principal investigator
Name 62678 0
Miss Ashleigh Sushames
Address 62678 0
Centre for Chronic Disease Prevention-Division of Tropical Health and Medicine,
Building D3, James Cook University
McGregor Rd, Smithfield,
Queensland,
Australia, 4870
Country 62678 0
Australia
Phone 62678 0
+61 7 423 22139
Fax 62678 0
Email 62678 0
[email protected]
Contact person for public queries
Name 62679 0
Ashleigh Sushames
Address 62679 0
Centre for Chronic Disease Prevention-Division of Tropical Health and Medicine,
Building D3, James Cook University
McGregor Rd, Smithfield,
Queensland,
Australia, 4870
Country 62679 0
Australia
Phone 62679 0
+61 7 42321061
Fax 62679 0
Email 62679 0
[email protected]
Contact person for scientific queries
Name 62680 0
Robyn McDermott
Address 62680 0
Centre for Chronic Disease Prevention-Division of Tropical Health and Medicine,
Building D3, James Cook University
McGregor Rd, Smithfield,
Queensland,
Australia, 4870
Country 62680 0
Australia
Phone 62680 0
+61 7 423 21575
Fax 62680 0
Email 62680 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
SourceTitleYear of PublicationDOI
EmbasePerceived barriers and enablers to participation in a community-tailored physical activity program with Indigenous Australians in a regional and rural setting: A qualitative study.2017https://dx.doi.org/10.1186/s12939-017-0664-1
N.B. These documents automatically identified may not have been verified by the study sponsor.