Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000627459
Ethics application status
Approved
Date submitted
4/05/2016
Date registered
16/05/2016
Date last updated
25/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational study of sociodemographic, lifestyle, health and dietary characteristics and socio-cultural behaviours of Greek Australians from MEDiterranean ISlands: the MEDIS-Australia Study.
Scientific title
An observational study of sociodemographic, psychosocial, health and dietary characteristics of Greek Australians from MEDiterranean ISlands to assess impact of migration and socio-cultural behaviours on adherence to a Greek Mediterranean dietary pattern and the presence of risk factors for cardiovascular disease and metabolic syndrome: the MEDIS-Australia Study.
Secondary ID [1] 289082 0
Nil known
Universal Trial Number (UTN)
U1111-1182-3309
Trial acronym
MEDIS-Australia Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk of Cardiovascular Disease 298529 0
Metabolic Syndrome 298530 0
Depression 298531 0
Condition category
Condition code
Cardiovascular 298619 298619 0 0
Other cardiovascular diseases
Diet and Nutrition 298620 298620 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 298621 298621 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will evaluate sociodemographic, health, psychosocial (lifestyle) and dietary characteristics of Greek Australians originally from Greek islands, over 65 years of age without heart disease but with CVD risk factors and markers for metabolic syndrome. Baseline observations will be made by an Accredited Practising Dietitian (APD), participants will not be followed up. An in-person interview will be conducted to administer a bilingual modified lifestyle (MEDIS-LQ) and food frequency questionnaire (MEDIS-FFQ) modelled on the questionnaire used to investigate elderly Greeks living in Greek islands (Tyrovolas et al, 2009; Tyrovolas et al, 2010). Additional questions and foods in the modified MEDIS-Australia questionnaire were included to address the lack of an ethnic-specific questionnaire to measure dietary characteristics and socio-cultural behaviours such as religious fasting, traditional cooking methods/dishes and home gardening. Otherwise, the questionnaire remains consistent with the original MEDIS questionnaire.
The modified MEDIS-LQ includes;
-Sociodemographic variables (gender, date of birth, island of origin, year of migration, years lived in Australia, SES, education level, years of education, marital status, household circumstances.
-Health variables (smoking status, access to, and type of health services used, self-reported medical conditions, hypertension, hypercholesterolemia, diabetes, constipation, physical activity.
-Psychosocial variables ( religious fasting, days of fasting per year, home gardening, depressive symptoms). The previously validated Geriatric Depression Scale. (GDS) for assessment of depressive symptoms (*Mamplekou et al, 2010; Yesavage et al,1983; Fountoulakis et al, 1999).
The modified MEDIS-FFQ includes;
-Dietary variables (frequency of consumption of food groups and individual foods from which to measure adherence using two diet scores and portion specific estimates to determine intake in grams per day and an analysis of nutrient intake).
Additional health characteristics will be collected by the dietitian. Anthropometric measures (weight, height, waist,hip and neck circumferences) of enrolled participants and their clinical history will be obtained to screen for exclusion criteria related to history of CVD and to evaluate risk of CVD and MetS. Participant signed consent will enable access to medical history from the general practitioner as nominated by each participant to obtain most recent blood pressure measure, blood test results and current prescribed medications (6-12 months preceding recruitment).
The impact of migration on the level of adherence to a Greek Mediterranean dietary pattern will be assessed and the relationships between socio-cultural characteristics and behaviours with adherence to traditional Greek dietary pattern and cuisine and the presence of CVD risk factors and risk of MetS will be evaluated. The study cohort of elderly Greek Australian migrants from islands will be compared to their counterparts living on these islands.
*Tyrovolas et al, 2009. Level of Adherence to the Mediterranean Diet Among Elderly Individuals Living in Mediterranean Islands: Nutritional Report from the Medis Study. Ecol of Food and Nutrition, 48:1,76-87.
*Tyrovolas et al, 2010. Repeatability and Validation of a Short, Semi-Quantitative Food Frequency Questionnaire Designed for Older Adults Living in Mediterranean Areas: The MEDIS-FFQ.
*Mamplekou et al, 2010. Urban environment, physical activity and unhealthy dietary habits correlate to depression among elderly in Eastern Mediterranean Islands: The MEDIS (MEDITERRANEAN ISLANDS ELDERLY) STUDY.
*Yesavage et al, 1983. Development and validation of a geriatric depression screening scales: a preliminary report. J Psych Research, 17:37-49.
*Fountoulakis et al, 1999. The validation of the short form of the Geriatric Depression Scale (GDS) in Greece. Aging (Milano), 11:367-372.
Intervention code [1] 294591 0
Not applicable
Comparator / control treatment
No control group.
However, the cohort of elderly Greek Australian migrants from islands will be compared to a cohort of older Greeks living on Greek islands and were enrolled into the MEDIS Epidemiological Study conducted in 2005. The Greek Australian migrant cohort will be compared to a cohort of elderly Greek Australians from past migrant studies that revealed the Australian Greek migrant paradox i.e lower all-cause and CVD mortality rates compared to the broader Australian population, despite a more adverse risk factor profile.
Control group
Historical

Outcomes
Primary outcome [1] 298111 0
The level of adherence.
Adherence to the traditional plant-based Greek Mediterranean diet will be assessed using two previously validated a priori diet scores; the MEDIS MedDietScore (0-55) and the Mediterranean Diet Pattern Score or MDPS (0-9). .
Instrument to be used for assessment will be the modified MEDIS-Australia Study FFQ.
Timepoint [1] 298111 0
One-off interview at baseline.
The diet scores and level of adherence will be determined from data collected at baseline.
Participants will not be followed up.
Primary outcome [2] 298112 0
Impact of migration upon adherence.
To determine years lived in Australia, the year of migration will be collected from the modified MEDIS-LQ.
The impact of migration (years in Australia) will be evaluated against data collected from the modified MEDIS- LQ (sociodemographic, lifestyle/psychosocial, health characteristics) and MEDIS-FFQ (diet characteristics and diet scores).
Timepoint [2] 298112 0
One-off interview at baseline.
Participants will not be followed up.
Primary outcome [3] 298288 0
CVD risk factor profile.
Data collected from the modified MEDIS questionnaire (LQ), clinical history (6-12 months preceding study enrollment) and anthropometric measures (weight, height, waist,hip and neck circumference) will be used to classify (compared to reference ranges and/or clinical guidelines in current literature) and determine the prevalence of risk factors for CVD within the study cohort.
Dyslipidemia- one or more elevated blood lipids (LDL, HDL, triglycerides) and/or prescribed lipid-lowering medication(s)..
Hypercholesterolemia- elevated blood total cholesterol and/or prescribed lipid-lowering medications(s).
Hypertension-,systolic and diastolic blood pressure equal or greater than 140/90 and/or taking prescribed medication(s).
Type 2 diabetes mellitus- elevated fasting blood glucose (equal or greater than 5.5 mmol/L), or Hba1c>7% and/or taking prescribed medication(s).
Obesity- body mass index (BMI) equal or greater than 30 kg/m2. Measured weight and height will be used to calculate BMI.
Inactivity- modified questionnaire (MEDIS-LQ) will be used to assess the frequency, duration and intensity of physical activity reported. Participants will be classified as highly active, moderately active or inactive using previously validated IPAQ criteria consistent with the MEDIS study conducted in Greece (*Craig et al, 2003;Tyrovolas et al, 2009).
Smoking status- modified questionnaire (MEDIS-LQ) will be used to assess participants as current smokers, former smokers, non-smokers (Tyrovolas et al, 2009).
*Craig et al (2003). International Physical Activity Questionnaire: 12-country Reliability and Validity. Medical Science Sports Exercise, 35, 1381-1395.
*Tyrovolas et al (2009). Level of Adherence to the Mediterranean Diet Among Elderly Individuals Living in Mediterranean Islands: Nutritional Report from the Medis Study. Ecology of Food and Nutrition, 48:1,76-87.
Timepoint [3] 298288 0
One-off interview (questionnaire and anthropometric measures), collection of clinical medical history at baseline.
Participants will not be followed up.
Secondary outcome [1] 323204 0
Depressive symptoms.
Assessment will be conducted using the modified MEDIS-LQ which includes a 15-item Geriatric Depression Scale (GDS) previously validated and used to assess depressive symptoms in elderly Greeks living in Greek islands (*Mamplekou et al, 2010; Yesavage et al,1983; Fountoulakis et al, 1999).
Timepoint [1] 323204 0
One-off interview at baseline.
Participants will not be followed up.
Secondary outcome [2] 323205 0
Metabolic Syndrome (MetS)
NCEP ATP III clinical diagnostic criteria will be used to classify participants with MetS and therefore estimate the prevalence within the study cohort (Grundy et al, 2005).

Data collected from the modified MEDIS questionnaire (LQ) and clinical history (6-12 months preceding study enrollment) will be used to determine markers of MetS. Three out of five criteria indicate MetS;
1. Waist circumference - will be measured by dietitian.
2. Triglyceride level - blood test from clinical medical history.
3. HDL level - blood test from clinical medical history.
4. Blood pressure - measure from clinical medical history.
5. Fasting blood glucose level - blood test from clinical medical history.
Timepoint [2] 323205 0
MetS will be determined from data collected from:
1. One baseline interview (measure of waist circumference)
2. Most recent clinical medical history, 6-12 months preceding study enrollment (TG and HDL levels, blood pressure reading, and fasting blood glucose result).
Secondary outcome [3] 323206 0
Retention of socio-cultural behaviours.
To evaluate the association between behaviours and adherence to the dietary pattern. (enable / inhibit).
Instrument used: modified MEDIS questionnaire (LQ and FFQ).
The MEDIS-Australia Study two-part questionnaire was modelled on a previously validated and repeatable questionnaire used for elderly Greeks living in Greek islands (*Tyrovolas et al, 2010).
*Repeatability and validation of a short, semi-quantitative food frequency questionnaire designed for older adults living in Mediterranean areas: the MEDIS-FFQ. J Nutr Elder;29(3) 211-324),
Timepoint [3] 323206 0
One off interview at baseline. Participants will not be followed up.

Eligibility
Key inclusion criteria
Study participants will include first generation Greek Australians originally from Cyprus and Greek islands such as Crete, i.e. live in Australia, were born and lived overseas in Greek islands or Cyprus, up until migration to Australia. Participants will be free from known history of CVD or active cancer but participants with Type 2 diabetes will be included. Participants will be independently, free-living in the community.
Participants in the MEDIS-Australia Study will not previously have been participants of the original MEDIS cohort in Greece conducted in 2005.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals originally from mainland Greece. Individuals with known history of CVD and / or complications of heart disease (e.g. angina, CABGs, myocardial infarction etc) and/or living in assisted accommodation e.g. nursing homes.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
The minimum target sample size is 150 participants over the recruitment period to meet study aims. A power calculation (SPSS Sample Power), the pending level of community group support for recruitment and availability of Greek-speaking research assistants were factors considered to determine a feasible target size for this study. Furthermore, the sample sizes from each Greek island in the MEDIS Epidemiological Study were considered to enable a comparison of older Greek Australians to their counterparts living in Greek islands and Cyprus.
A t-test for two independent samples with common variance and alpha .05 (two-tailed) was based on the mean MedDietScore (0-55) (Tyrovolas et al, 2009). 150 participants is estimated to have a power of 90% and mean difference in MedDietScore between the two cohorts (Greek-Islander Australians v MEDIS Greeks still living in Greek islands ) with 95% CI of +/- 0.73 points. An observed difference of 1.2 points in the MedDietScore would correspond to a 95% CI of 0.47 to 1.93.
The statistical methods to be used for the MEDIS-Australia Study will include descriptive statistics and multivariate analyses.
Descriptive statistics will be presented as follows.
CATEGORICAL VARIABLES;
- As frequencies.
- Associations between categorical variables will be explored and compared using Pearson’s Chi square test with p-value < 0.05 statistically significant.

Normality of the distribution will be assessed by Kolmogorov-Smirnov statistic. Distribution of scores will be checked for skewness, kurtosis, normality and presence of outliers.

CONTINUOUS VARIABLES - NORMALLY DISTRIBUTED;
- Mean and standard deviation.
- Minimum and maximum values for variables if appropriate.
- Independent samples t-test and ANOVA will be used to test for differences and compare between groups.
CONTINUOUS VARIABLES - SKEWED;
- Median and 95% confidence intervals.
- Non-parametric Mann-Whitney U-test and Kruskal-Wallis test for detecting differences between groups.

Multivariate analyses will be undertaken to identify covariates and confounders of predictors of designated outcomes. Principle components analysis will be used as a data reduction technique to detect components among inter-relationships between variables to explain variability.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293458 0
University
Name [1] 293458 0
La Trobe University
Country [1] 293458 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Discipline of Dietetics and Human Nutrition
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
College of Science, Health and Engineering.

La Trobe University
Plenty Road & Kingsbury Drive, Melbourne, VIC 3086
Country
Australia
Secondary sponsor category [1] 292280 0
None
Name [1] 292280 0
Address [1] 292280 0
Country [1] 292280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294902 0
Faculty of Human Ethics Committee (FHEC), La Trobe University.
Ethics committee address [1] 294902 0
Ethics committee country [1] 294902 0
Australia
Date submitted for ethics approval [1] 294902 0
20/06/2011
Approval date [1] 294902 0
18/08/2011
Ethics approval number [1] 294902 0
FHEC 11 / 127

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

Contacts
Principal investigator
Name 65402 0
A/Prof Catherine Itsiopoulos
Address 65402 0
Health Sciences Building 1, Allied Health Executive Office, Room 256
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
College of Science, Health and Engineering

La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
Country 65402 0
Australia
Phone 65402 0
+61 (0) 3 9479 1721
Fax 65402 0
Email 65402 0
[email protected]
Contact person for public queries
Name 65403 0
Catherine Itsiopoulos
Address 65403 0
Health Sciences Building 1, Allied Health Executive Office, Room 256
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
College of Science, Health and Engineering

La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
Country 65403 0
Australia
Phone 65403 0
+61 (0) 3 9479 1721
Fax 65403 0
Email 65403 0
[email protected]
Contact person for scientific queries
Name 65404 0
Catherine Itsiopoulos
Address 65404 0
Health Sciences Building 1, Allied Health Executive Office, Room 256
Department of Rehabilitation, Nutrition and Sport
School of Allied Health
College of Science, Health and Engineering

La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
Country 65404 0
Australia
Phone 65404 0
+61 (0) 3 9479 1721
Fax 65404 0
Email 65404 0
[email protected]

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No Supporting Document Provided



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