Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12623001045606
Ethics application status
Approved
Date submitted
21/08/2023
Date registered
27/09/2023
Date last updated
27/09/2023
Date data sharing statement initially provided
27/09/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
Healthy Eating in Haemodialysis Study
Query!
Scientific title
Healthy Eating in Haemodialysis – a prospective cohort study
Query!
Secondary ID [1]
310425
0
none
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
HEHD study
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
kidney failure
331189
0
Query!
hemodialysis
331190
0
Query!
Condition category
Condition code
Renal and Urogenital
327966
327966
0
0
Query!
Kidney disease
Query!
Diet and Nutrition
327967
327967
0
0
Query!
Other diet and nutrition disorders
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Information collected from participant medical records at the baseline visit includes date of kidney failure and length of time since commencing renal replacement therapy; pre-dialysis laboratory values for the preceding 3 months for serum potassium, sodium and phosphate, and medical history of cardiovascular disease, hypertension, diabetes and smoking status (never, former, current),
At the initial study visit during a hemodialysis session 4 questionnaires are completed - the EPIC food frequency questionnaire, EQ5D5L quality of life questionnaire, the FACIT-F fatigue questionnaire and the KDQOL kidney disease quality of life questionnaire during a 75 minute visit.
Diet quality measured as:
1. Alternative Healthy Eating Index (AHEI) score
2. Healthy Eating Index For Australians (HEIFA) score
3. total weekly serves of fruits and vegetables
The observation time period is up to five years, with diet quality assessed once a year using the food frequency questionnaire.
The first event is classified as the first episode of death, myocardial infarction, stroke, or
hospitalisation for congestive heart failure after study enrolment.
Query!
Intervention code [1]
326827
0
Not applicable
Query!
Comparator / control treatment
not applicable
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
335823
0
Composite variable for the combined outcome of all-cause mortality, or the first occurrence during the study period of a cardiovascular event. A cardiovascular event is defined as myocardial infarction, stroke, or congestive heart failure requiring hospitalization and treatment with inotropes, vasodilators or diuretics.
Cardiovascular events (Myocardial Infarction, Stroke, Cardiac arrest, hospitalisation for heart failure) and all-cause mortality will be recorded from electronic medical records. Site lead investigators will be responsible for collecting this data, through automated or manual reporting as preferred at each site.
Query!
Assessment method [1]
335823
0
Query!
Timepoint [1]
335823
0
Within 5 years of enrolling in this study, reviewed once a year for up to 5 years with censoring at the date of the first event
Query!
Secondary outcome [1]
425797
0
Overall diet quality measured as the Australian Dietary Guidelines recommended serves of core food groups, AHEI score and HEIFA score
Query!
Assessment method [1]
425797
0
Query!
Timepoint [1]
425797
0
baseline, annually up to 5 years post baseline
Query!
Secondary outcome [2]
425798
0
Fatigue assessed by FACIT-F Questionnaire
Query!
Assessment method [2]
425798
0
Query!
Timepoint [2]
425798
0
baseline
Query!
Secondary outcome [3]
425799
0
Quality of life assessed by KDQOL-SF questionnaire
Query!
Assessment method [3]
425799
0
Query!
Timepoint [3]
425799
0
baseline
Query!
Secondary outcome [4]
425800
0
Quality of life assessed using EQ-5D-5L questionnaire
Query!
Assessment method [4]
425800
0
Query!
Timepoint [4]
425800
0
baseline
Query!
Secondary outcome [5]
425801
0
Energy intake from FFQ data analysis
Query!
Assessment method [5]
425801
0
Query!
Timepoint [5]
425801
0
baseline, annually up to 5 years post baseline
Query!
Secondary outcome [6]
426929
0
Protein intake from FFQ data analysis
Query!
Assessment method [6]
426929
0
Query!
Timepoint [6]
426929
0
baseline, annually up to 5 years post baseline
Query!
Secondary outcome [7]
426930
0
Fat intake from FFQ data analysis
Query!
Assessment method [7]
426930
0
Query!
Timepoint [7]
426930
0
baseline, annually up to 5 years post baseline
Query!
Secondary outcome [8]
426931
0
Carbohydrate intake from FFQ data analysis
Query!
Assessment method [8]
426931
0
Query!
Timepoint [8]
426931
0
baseline, annually up to 5 years post baseline
Query!
Secondary outcome [9]
426932
0
Fibre intake from FFQ data analysis
Query!
Assessment method [9]
426932
0
Query!
Timepoint [9]
426932
0
baseline, annually up to 5 years post baseline
Query!
Secondary outcome [10]
426933
0
Sodium intake from FFQ data analysis
Query!
Assessment method [10]
426933
0
Query!
Timepoint [10]
426933
0
baseline, annually up to 5 years post baseline
Query!
Secondary outcome [11]
426934
0
Potassium intake from FFQ data analysis
Query!
Assessment method [11]
426934
0
Query!
Timepoint [11]
426934
0
baseline, annually up to 5 years post baseline
Query!
Secondary outcome [12]
426935
0
Phosphorus intake from FFQ data analysis
Query!
Assessment method [12]
426935
0
Query!
Timepoint [12]
426935
0
baseline, annually up to 5 years post baseline
Query!
Eligibility
Key inclusion criteria
1. Aged 18 to 70 years
2. Undergoing haemodialysis for more than 90 days and currently dialysing in a hospital dialysis centre (may not be on a hospital site) or having dialysis at home.
3. English speaking.
4. Able to provide written informed consent.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Unable to complete questionnaires with the aid of a researcher
Query!
Study design
Purpose
Natural history
Query!
Duration
Longitudinal
Query!
Selection
Defined population
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Normally distributed variables were expressed as mean (standard deviation) and skewed distributions as median (interquartile range). Categorical variables will be calculated using frequencies and percentages.
Characteristics of dietary components will be described as diet quality. This will be calculated by the participants adherence to food groups recommendations and specific dietary nutrients against the standard reference values. Alternative Healthy Eating Index (AHEI) scores will be categorised into tertiles. The FFQ EPIC Tool for Analysis (FETA) will be used to convert EPIC-M FFQ data into nutrient and food group values (14). The data will be converted into the daily macronutrient estimates, total fibre, saturated fat, potassium phosphorus and sodium intakes, with nutrient intake corrected for total energy intake.
Food group consumption will be calculated by converting total weights of food groups by the weight of a standard serving for the following groups as per the Australian National Dietary Guidelines, Eat for Health (The Australian Dietary Guidelines, 2013) and converted into serves per day for men and women for these food groups:
• Vegetables and legumes/beans
• Fruit
• Grain (cereal) foods, including wholegrain and refined grain varieties
• Lean meats and poultry, fish, eggs, tofu, nuts and seeds and legumes/beans
• Milk, yoghurt cheese and/or alternatives.
• Discretionary Foods
Micronutrient intake will be compared to Australian Nutrient reference values. Associations between participants HEIFA or AHEI tertiles and FACIT-F categories will be performed using the Chi-Square Test and/or Fisher’s Exact Test for categorical variables as appropriate. The type one error of less than 5% (p <0.05) will be accepted. Parametric or non-parametric correlation coefficients will be used to examine associations between AHEI score, fruit and vegetable serves and protein with FACIT-F score, and with KDQOL-SF™ summary score and domain scores.
Weekly servings of fruit and vegetables will be modelled as continuous variables (total fruit and vegetables, and total fruit and total vegetables) and categorised into tertiles. Univariate analysis for the time to the combined event by HEIFA or AHEI tertile, and fruit and vegetable tertile will be performed using Kaplan–Meier curves with log-rank tests. Person time for each participant will be calculated from the data of data collection to the first event or until censoring, or until the end of the follow up period.
Multivariable Cox proportional hazards regression models adjusting for diabetes, hypertension, ethnicity, smoking status, years of dialysis, IRSD quintile and baseline BMI will be performed, and hazard ratios reported with 95% confidence intervals (CIs). Models for fruit and vegetable intake will also be adjusted for total energy intake. All the analyses of fruit serves will be adjusted for vegetable serves and vice versa. Effect modifications of the association between AHEI and mortality by age and sex will be tested using interaction terms for servings of fruit or vegetables in the multivariable models.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/04/2023
Query!
Date of last participant enrolment
Anticipated
26/09/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
30/08/2030
Query!
Actual
Query!
Sample size
Target
612
Query!
Accrual to date
52
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
25419
0
Royal Brisbane & Womens Hospital - Herston
Query!
Recruitment hospital [2]
25420
0
Sunshine Coast University Hospital - Birtinya
Query!
Recruitment hospital [3]
25421
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment postcode(s) [1]
41161
0
4029 - Herston
Query!
Recruitment postcode(s) [2]
41162
0
4575 - Birtinya
Query!
Recruitment postcode(s) [3]
41163
0
4102 - Woolloongabba
Query!
Funding & Sponsors
Funding source category [1]
314633
0
University
Query!
Name [1]
314633
0
Queensland University of Technology
Query!
Address [1]
314633
0
Victoria Park Road, Kelvin Grove, Qld 4059
Query!
Country [1]
314633
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
Royal Brisbane and Women's Hospital
Query!
Address
Butterfield Street, Herston, Qld 4029
Query!
Country
Australia
Query!
Secondary sponsor category [1]
316598
0
None
Query!
Name [1]
316598
0
Query!
Address [1]
316598
0
Query!
Country [1]
316598
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
313654
0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Query!
Ethics committee address [1]
313654
0
Office for Research Governance & DevelopmentLevel 2, PED Building1 Hospital Boulevard, Southport, QLD, 4215
Query!
Ethics committee country [1]
313654
0
Australia
Query!
Date submitted for ethics approval [1]
313654
0
27/06/2022
Query!
Approval date [1]
313654
0
13/12/2022
Query!
Ethics approval number [1]
313654
0
HREC/2022/QGC/80735
Query!
Summary
Brief summary
Haemodialysis cleans the blood and replaces some of the function of the kidneys when they are no longer working. Patients undergoing haemodialysis have traditionally been prescribed diets low in fruits and vegetables and high in animal protein, sugar and fat to prevent malnutrition and limit dietary potassium and phosphate.
Research has shown that healthy diet patterns high in fruits, vegetables, nuts and legumes, and lower in meat and processed food are associated with lower risk of death in those with early stages of kidney disease, however studies examining these outcomes for haemodialysis patients are sparse.
The aim of the study is to examine the extent to which healthy diet patterns and meeting core food requirements occur in our patients requiring haemodialysis and follow up participants for up to 5 years for heart disease related events. The study will use a questionnaire to collect information on dietary intake from patients undergoing haemodialysis. Data will be examined for diet quality by food groups and assessed against healthy diet criteria.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
128894
0
A/Prof Helen MacLaughlin
Query!
Address
128894
0
School of Exercise and Nutrition Sciences
QUT Kelvin Grove
Qld 4059
Query!
Country
128894
0
Australia
Query!
Phone
128894
0
+61 7 31385799
Query!
Fax
128894
0
Query!
Email
128894
0
[email protected]
Query!
Contact person for public queries
Name
128895
0
A/Prof Helen MacLaughlin
Query!
Address
128895
0
School of Exercise and Nutrition Sciences
QUT Kelvin Grove
Qld 4059
Query!
Country
128895
0
Australia
Query!
Phone
128895
0
+61 7 31385799
Query!
Fax
128895
0
Query!
Email
128895
0
[email protected]
Query!
Contact person for scientific queries
Name
128896
0
A/Prof Helen MacLaughlin
Query!
Address
128896
0
School of Exercise and Nutrition Sciences
QUT Kelvin Grove
Qld 4059
Query!
Country
128896
0
Australia
Query!
Phone
128896
0
+61 7 31385799
Query!
Fax
128896
0
Query!
Email
128896
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Participants did not consent to data sharing.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20071
Study protocol
[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.
Download to PDF