Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000512628
Ethics application status
Approved
Date submitted
21/03/2014
Date registered
14/05/2014
Date last updated
14/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Albany Physical Activity & Nutrition Project: A home-based physical activity and nutrition program targeting middle-aged adults at risk of metabolic syndrome in a disadvantaged rural community
Scientific title
A randomised controlled trial of a physical activity and nutrition program targeting middle-aged adults at risk of metabolic syndrome in a disadvantaged rural community
Secondary ID [1] 284301 0
None
Universal Trial Number (UTN)
Trial acronym
APAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 291447 0
Type 2 diabetes mellitus 291448 0
Cardiovascular disease 291449 0
Overweight/obesity 291450 0
Condition category
Condition code
Public Health 291820 291820 0 0
Health promotion/education
Diet and Nutrition 292179 292179 0 0
Obesity
Metabolic and Endocrine 292240 292240 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As part of this 6-month home-based intervention, each participant (n=250) will be provided with a package designed to educate, motivate, and support improvement in nutrition and levels of physical activity through goal setting, based on the principles of Self-Determination Theory and Motivational Interviewing. The program will empower individuals to self-manage and monitor their health behaviours and weight within their own environment (home-base). The approach will take particular care to emphasise the importance of regular self-weighing which is widely associated with greater weight loss (showing a 1 to 3 BMI unit advantage over individuals who do not self-weight frequently).

The Albany Physical Activity & Nutrition (APAN) program is based on the physical activity and nutrition programs (Physical Activity & Nutrition for Seniors [PANS] and Perth Active Living Seniors [PALS]) specifically designed for older adults. It will incorporate objective measures not previously included in the PALS and PANS studies and will be adapted for the younger age group and the regional context. The intervention is safe, accessible, and low cost. It will commence at a low level of physical activity, with aerobic, strength and flexibility components commensurate to the fitness level of each individual. The educational materials will provide illustrations and tips on how to perform exercises safely. The physical activity component will use accelerometers to measure programmed and incidental physical activity. Participants will perform two 30 minute strength sessions per week, and at least one 30 minute moderate activity per day. The nutrition component consists of suggested meal plans, recipes, and tips on healthy eating, encouraging a higher consumption of fruit/vegetables and fibre while reducing intake of saturated fat and sugar.

Program resources will include a booklet, exercise chart, resistance band, newsletters, and website access to log nutrition and physical activity behaviours. Telephone contact will be made with participants at weeks 3, 6, 12, 18 and 24 of the intervention. Follow-up emails will be used in addition, and participants will also have the option to contact research assistants.
Intervention code [1] 289023 0
Lifestyle
Intervention code [2] 289024 0
Early detection / Screening
Intervention code [3] 289025 0
Prevention
Comparator / control treatment
The control group (n=250) will be placed on a ‘waitlist’ to receive the intervention after they complete the post-test data collection. Post-test data will be collected from both intervention and control group participants by research staff.
Control group
Active

Outcomes
Primary outcome [1] 291738 0
Insulin sensitivity (insulin, glucose) - measured by fasting blood samples
Timepoint [1] 291738 0
6 months post completion of the intervention program
Primary outcome [2] 291739 0
Waist circumference
Waist and hip circumference will be measured standing up at the level midway between the lowest rib margin and the iliac crest to the nearest 0.5 cm. Hip circumference will be measured at the largest level of the symphysis pubis and gluteus maximus. Waist-to-hip ratio will be calculated as waist circumference divided by hip circumference.
Timepoint [2] 291739 0
6 months post completion of the intervention program
Primary outcome [3] 292057 0
Lipid profile (cholesterol, triglycerides)
The concentrations of triglycerides, total cholesterol and HDL cholesterol will be measured allowing determination of total-, LDL-, HDL-, and non-HDL-cholesterol levels. All blood tests will be performed by Western Diagnostic Pathology.
Timepoint [3] 292057 0
6 months post completion of the intervention program
Secondary outcome [1] 307374 0
Self-reported and objectively measured levels of physical activity (incidental and programmed) and sedentary behaviour - measured by ActiGraph GT3X Accelerometers and the International Physical Activity Questionnaire
Timepoint [1] 307374 0
6 months post completion of the intervention program
Secondary outcome [2] 307375 0
Self-reported dietary habits, specifically a reduction in saturated fat and sugar and an increase in fibre, fruit, and vegetable consumption - measured by the Fat & Fibre Barometer.
Timepoint [2] 307375 0
6 months post completion of the intervention program
Secondary outcome [3] 307376 0
Cost-effectiveness of the program determined by an economic analysis
Economic analysis of the cost-effectiveness of the intervention program will be conducted by a Health Economist. This will involve two distinct elements; firstly, a cost analysis of the physical activity and nutrition program which will provide estimates of the actual cost of the program and inferences into cost of future programs. The second aspect will include the undertaking of cost-effectiveness. Quality of life will be measured using the validated EQ-5D-3L questionnaire which is a standardised measure of health status developed by the EuroQol Group. The self-complete EQ-5D-3L questionnaire will be administered at baseline and post-test. This is a simple questionnaire which is cognitively undemanding, taking only a few minutes to complete. Sensitivity analysis will be undertaken to test the robustness of the results.
Timepoint [3] 307376 0
6 months post completion of the intervention program
Secondary outcome [4] 308098 0
BMI
Timepoint [4] 308098 0
6 months post completion of the intervention program
Secondary outcome [5] 308099 0
Waist-to-hip ratio - calculated as waist circumference divided by hip circumference
Timepoint [5] 308099 0
6 months post completion of the intervention program
Secondary outcome [6] 308100 0
Blood pressure - measured using an Omron M5-1 electronic sphygmomanometer. A mean value will be recorded after three consecutive measurements
Timepoint [6] 308100 0
6 months post completion of the intervention program

Eligibility
Key inclusion criteria
Study participants will be required to be 50-69 years, insufficiently active (less than 150 minutes of moderate physical activity per week), and satisfying the following International Diabetes Federation metabolic syndrome criteria: central obesity (waist circumference greater than 94 cm men or greater than 80 cm women [Europids, Sub-Saharan Africans, Eastern Mediterranean, Middle East]; greater than 90cm men or greater than 80cm women [South Asians, Chinese, Japanese]); plus any two of: raised triglyceride level (greater than 1.7 mM, or treatment for this); reduced HDL-cholesterol (less than 1.03 mM in males and less than 1.29 mM in females, or treatment for this); raised blood pressure (systolic equal to 130 mmHg or diastolic equal to 85 mmHg, or treatment of previously diagnosed hypertension); raised fasting plasma glucose (equal to 5.6 mM). To be at risk of metabolic syndrome, only one instead of two of the above parameters must be satisfied in addition to central obesity.
Minimum age
50 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will apply: previous diagnosis of diabetes mellitus (other than gestational diabetes); receiving treatment to lower blood glucose; on a weight loss diet or having weight fluctuations of greater than 5% within the past 6 months; involvement in another physical activity program; or a partner/individual residing in the same household as another participant already recruited for the study (to avoid contamination).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Screening stage 1: Potential participants will be initially screened via the Computer Assisted Telephone Interview system (CATI), which is an efficient method of recruitment as per experience with previous studies conducted by the Investigators. Screening will incorporate a number of diabetes risk factors based on AUSDRISK, an Australian T2DM risk assessment tool utilising anthropometric, lifestyle and demographic measures. This simple and reliable questionnaire will screen those at high risk of developing T2DM (risk score greater than or equal to 12). Findings from the pilot test indicate that in order to achieve the required sample size, the AUSDRISK scores will be ranked and 1000 people with the highest scores will be identified for potential inclusion into the study.

Screening stage 2: After stage 1, participants (n=1000) meeting the initial selection criteria and indicating an interest in the study will be sent information explaining the home-based intervention project, their rights, and confidentiality details. An appointment will then be made for them to attend a central location for anthropometric measurements and completion of a questionnaire.

Screening stage 3: Participants with confirmed central obesity based on screening stage 2 results will then be asked to attend a blood collection centre for the collection of a fasting blood sample (triglycerides, glucose, cholesterol) to determine their metabolic syndrome status. Participants with confirmed metabolic syndrome will also have insulin and C-reactive protein tests performed.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random assignment to intervention and control groups will occur after screening (n=625), with quota sampling for gender. Suburbs will be ranked according to SEIFA and equal numbers of low and high scoring suburbs will be allocated to each group to minimise contamination. Simple randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparisons between the changes in intervention group and the control group will be performed using univariate and multivariable statistical methods. Outcome variables at baseline and post-intervention will be used to test the hypotheses in association with the covariates and confounding demographic and lifestyle variables. Continuous and categorical outcomes will be analysed using 2-part generalised linear mixed regression models, accounting for the correlations between repeated measures and clustering of the data. Intention-to-treat analysis will be conducted to assess sensitivity of the results to the expected attrition and withdrawal of participants from the RCT.

Qualitative Data: All qualitative data will be transcribed within two weeks of interviewing. At least 10% of all data will be randomly selected and reviewed. Data will be coded and common themes or categories created. Data will be collated, presented thematically and supported by direct quotes from participants. Data management of full transcripts and other text will be facilitated by NVIVO. Participants’ permission will be obtained and they will not be identified in transcripts.

Economic analysis: The economic analysis will be conducted alongside the RCT. The evaluation will involve both a cost analysis and cost-effectiveness analysis. This will be carried out from the perspective of the health services, including both Medicare and non-Medicare health costs, over a time horizon of 2 years. A cost analysis will provide information relating to set up, recruitment and program implementation of the RCT. While the analysis will provide specific cost details about running the RCT, the main interest will focus on the costs associated with future roll-out. Estimation will allow healthcare organisations to gauge the cost of conducting a similar program in the future.

The cost-effectiveness analysis of the trial intervention will involve the construction of a decision analytical model that captures data on both the cost and effectiveness of the intervention and non-intervention groups. The cost-effectiveness analysis will compare the difference in costs and effectiveness of the intervention and control groups, by calculating the incremental cost per Quality-Adjusted Life-Years gained by the intervention. Quality of life will be measured using the validated EQ-5D-3L questionnaire which is a standardised measure of health status developed by the EuroQol Group. The self-complete EQ-5D-3L questionnaire will be administered at baseline and post-test. This is a simple questionnaire which is cognitively undemanding, taking only a few minutes to complete. Sensitivity analysis will be undertaken to test the robustness of the results.

The power calculations are based on a logistic mixed regression model with the outcome variable being the prevalence of physical activity participation. Assuming 80% complete data across the assessments due to attrition and non-respondents, a total of n=625 subjects satisfying the selection criteria will be initially recruited. In the power analyses, effect sizes of interest are associated with the time (pre-post) and intervention group parameters. For the mixed regression analysis, a final sample size of n=500 [125 per gender by intervention condition] will provide sufficient power (80%) to detect a medium effect size at 5% significance level for the group by time interaction term accounting for gender but without other covariate adjustment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2014
Actual
Date of last participant enrolment
Anticipated
1/08/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
625
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 7889 0
6330 - Albany
Recruitment postcode(s) [2] 7890 0
6331 - Albany
Recruitment postcode(s) [3] 7891 0
6332 - Albany

Funding & Sponsors
Funding source category [1] 288933 0
University
Name [1] 288933 0
Curtin University
Country [1] 288933 0
Australia
Funding source category [2] 288934 0
Government body
Name [2] 288934 0
South West Medicare Local
Country [2] 288934 0
Australia
Primary sponsor type
University
Name
WA Centre for Health Promotion Research, Curtin University
Address
Curtin University, Kent St Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 287623 0
University
Name [1] 287623 0
Centre for Behavioural Research in Cancer Control, Curtin University
Address [1] 287623 0
Curtin University, 10 Selby St Shenton Park WA 6008
Country [1] 287623 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290758 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 290758 0
Ethics committee country [1] 290758 0
Australia
Date submitted for ethics approval [1] 290758 0
Approval date [1] 290758 0
02/10/2013
Ethics approval number [1] 290758 0
HR149/2013

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

Contacts
Principal investigator
Name 47110 0
Dr Jonine Jancey
Address 47110 0
Curtin University
Kent St
Bentley WA 6102
Country 47110 0
Australia
Phone 47110 0
+61892663807
Fax 47110 0
Email 47110 0
[email protected]
Contact person for public queries
Name 47111 0
Krysten Blackford
Address 47111 0
Curtin University
Kent St
Bentley WA 6102
Country 47111 0
Australia
Phone 47111 0
+61892662751
Fax 47111 0
Email 47111 0
[email protected]
Contact person for scientific queries
Name 47112 0
Peter Howat
Address 47112 0
Curtin University
Kent St
Bentley WA 6102
Country 47112 0
Australia
Phone 47112 0
+61892663807
Fax 47112 0
Email 47112 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
EmbaseA randomised controlled trial of a physical activity and nutrition program targeting middle-aged adults at risk of metabolic syndrome in a disadvantaged rural community.2015https://dx.doi.org/10.1186/s12889-015-1613-9
EmbaseEffects of a home-based intervention on diet and physical activity behaviours for rural adults with or at risk of metabolic syndrome: A randomised controlled trial.2016https://dx.doi.org/10.1186/s12966-016-0337-2
EmbaseHome-based lifestyle intervention for rural adults improves metabolic syndrome parameters and cardiovascular risk factors: A randomised controlled trial.2016https://dx.doi.org/10.1016/j.ypmed.2016.05.012
N.B. These documents automatically identified may not have been verified by the study sponsor.