Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000313932
Ethics application status
Approved
Date submitted
26/02/2020
Date registered
6/03/2020
Date last updated
6/03/2020
Date data sharing statement initially provided
6/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Food from Home Study: Dietary acculturation and heart disease risk factors among Chinese Immigrants in Australia
Scientific title
Food from Home Study: An observational study of dietary acculturation and the relationship to cardio-metabolic disease risk factors among Chinese Immigrants in Australia
Secondary ID [1] 300633 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 316409 0
type 2 diabetes 316410 0
Condition category
Condition code
Diet and Nutrition 314670 314670 0 0
Other diet and nutrition disorders
Cardiovascular 314761 314761 0 0
Other cardiovascular diseases
Metabolic and Endocrine 314762 314762 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are observing over 2 years the relationship between changes in diet (dietary acculturation) and risk factors for cardiovascular disease and type 2 diabetes in Chinese immigrants to Australia. Participants will complete questionnaires, and attend the research facility for anthropometric measurements, blood pressure assessment, AGE reading, and blood samples. All measurements will occur at Baseline, 12 months and 24 months. The expected time commitment annually is 3 hours.
Intervention code [1] 316962 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322995 0
Waist circumference, Measured in centimetres using a standard tape measure at the midpoint between the iliac crest and lowest rib.
Timepoint [1] 322995 0
Baseline, 12 months and 24 months
Secondary outcome [1] 380470 0
weight in kg using the 515/514 SECA Medical Body Composition Analyser (SECA Group, Hamburg, Germany)
Timepoint [1] 380470 0
Baseline, 12 months, 24 months
Secondary outcome [2] 380471 0
fasting triglycerides (finger prick autoanalyzer and serum assay following venepuncture)
Timepoint [2] 380471 0
Baseline, 12 months, 24 months
Secondary outcome [3] 380472 0
fasting glucose (finger prick autoanalyzer and plasma assay following venepuncture)
Timepoint [3] 380472 0
Baseline, 12 months, 24 months
Secondary outcome [4] 380473 0
fasting cholesterol (finger prick autoanalyzer and serum assay following venepuncture)
Timepoint [4] 380473 0
Baseline, 12 months, 24 months
Secondary outcome [5] 380474 0
Advanced glycation end-products (AGE), measured using skin autofluorescence through an automatic AGE reader
Timepoint [5] 380474 0
Baseline, 12 months, 24 months
Secondary outcome [6] 380475 0
Body mass index (kg/m2). Weigh measured using the 515/514 SECA Medical Body Composition Analyser (SECA Group, Hamburg, Germany) and height using a wall mounted stadiometer.
Timepoint [6] 380475 0
Baseline, 12 months, 24 months
Secondary outcome [7] 380476 0
Blood pressure using an automated blood pressure monitor (Omron).
Timepoint [7] 380476 0
Baseline, 12 months, 24 months
Secondary outcome [8] 380477 0
Insulin (plasma sample from venepuncture, radioimmunoassay)
Timepoint [8] 380477 0
Baseline, 12 months, 24 months
Secondary outcome [9] 380478 0
dietary intake (24 hour recall and fat Fibre Barometer questionnaire)
Timepoint [9] 380478 0
Baseline, 12 months, 24 months
Secondary outcome [10] 380479 0
Health status (EQ-5D-5L)
Timepoint [10] 380479 0
Baseline, 12 months, 24 months
Secondary outcome [11] 380480 0
Physical Activity (Global Physical Activity Questionnaire (GPAQ))
Timepoint [11] 380480 0
Baseline, 12 months, 24 months
Secondary outcome [12] 380481 0
Fat mass (SECA Bioelectrical impedance analyser)
Timepoint [12] 380481 0
Baseline, 12 months, 24 months
Secondary outcome [13] 380486 0
Dietary acculturation scale (survey tool) - Western Dietary Acculturation Scale and the Chinese Dietary Acculturation Scale. Satia, J.A., Patterson, R.E., Kristal, A.R., Hislop, T.G., Yasui, Y., & Taylor, V.M. (2001). Development of scales to measure dietary acculturation among Chinese-Americans and Chinese-Canadians. Journal of the American Dietetic Association, 101(5): 548–553. doi:10.1016/S0002-8223(01)00137-7.
Timepoint [13] 380486 0
Baseline, 12 months, 24 months

Eligibility
Key inclusion criteria
Age at Baseline 35-65 years
Born in Mainland China
First generation immigrant to Australia
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis of Type 2 diabetes or cardiovascular diseases, cancer or other related metabolic disease.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Appropriate regression analyses will be used to determine the relationship between exposure variables (age, gender, nutrient intake, dietary acculturation level etc.) and the outcome variable WC. Exploratory regression analyses will be used to look at the relationship with the exposure variable and secondary outcomes. For the primary outcome of change in waist circumference, we will need to include 208 participants (based on effect size of 0.1952304) in order to achieve 80% power.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/03/2020
Actual
Date of last participant enrolment
Anticipated
26/02/2021
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305057 0
University
Name [1] 305057 0
Monash University
Country [1] 305057 0
Australia
Primary sponsor type
Individual
Name
Dr Kate Huggins
Address
Monash University
Wellington Road
Clayton
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 305423 0
Individual
Name [1] 305423 0
Dr Tammie Choi
Address [1] 305423 0
Monash University
Wellington Road
Clayton
Victoria 3800
Australia
Country [1] 305423 0
Australia
Secondary sponsor category [2] 305431 0
Individual
Name [2] 305431 0
Dr Nicole Kellow
Address [2] 305431 0
Monash University
Wellington Road
Clayton
Victoria 3800
Australia
Country [2] 305431 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305444 0
Monash University Human Research Ethics
Ethics committee address [1] 305444 0
Ethics committee country [1] 305444 0
Australia
Date submitted for ethics approval [1] 305444 0
16/08/2019
Approval date [1] 305444 0
04/09/2019
Ethics approval number [1] 305444 0
19951

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

Contacts
Principal investigator
Name 100410 0
Dr Kate Huggins
Address 100410 0
Department of Nutrition, Dietetics and Food
School of Clinical Sciences at Monash Health
Level 1, 264 Ferntree Gully Rd
Notting Hill VIC 3168
Country 100410 0
Australia
Phone 100410 0
+61 3 9902 4269
Fax 100410 0
Email 100410 0
[email protected]
Contact person for public queries
Name 100411 0
Kate Huggins
Address 100411 0
Department of Nutrition, Dietetics and Food
School of Clinical Sciences at Monash Health
Level 1, 264 Ferntree Gully Rd
Notting Hill VIC 3168
Country 100411 0
Australia
Phone 100411 0
+61 3 9902 4269
Fax 100411 0
Email 100411 0
[email protected]
Contact person for scientific queries
Name 100412 0
Kate Huggins
Address 100412 0
Department of Nutrition, Dietetics and Food
School of Clinical Sciences at Monash Health
Level 1, 264 Ferntree Gully Rd
Notting Hill VIC 3168
Country 100412 0
Australia
Phone 100412 0
+61 3 9902 4269
Fax 100412 0
Email 100412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
After all publications have been completed, no end date determined
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator
[email protected]
Department of Nutrition, Dietetics and Food
School of Clinical Sciences at Monash Health
Level 1, 264 Ferntree Gully Rd
Notting Hill VIC 3168
Australia


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7076Study protocol  [email protected]
7077Informed consent form  [email protected]



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.