Trial Review

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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
Scientific title
Healthy Eating in Haemodialysis – a prospective cohort study
Secondary ID [1] 310425 0
none
Universal Trial Number (UTN)
Trial acronym
HEHD study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
kidney failure 331189 0
hemodialysis 331190 0
Condition category
Condition code
Renal and Urogenital 327966 327966 0 0
Kidney disease
Diet and Nutrition 327967 327967 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 326827 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

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.
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
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
Timepoint [1] 425797 0
baseline, annually up to 5 years post baseline
Secondary outcome [2] 425798 0
Fatigue assessed by FACIT-F Questionnaire
Timepoint [2] 425798 0
baseline
Secondary outcome [3] 425799 0
Quality of life assessed by KDQOL-SF questionnaire
Timepoint [3] 425799 0
baseline
Secondary outcome [4] 425800 0
Quality of life assessed using EQ-5D-5L questionnaire
Timepoint [4] 425800 0
baseline
Secondary outcome [5] 425801 0
Energy intake from FFQ data analysis
Timepoint [5] 425801 0
baseline, annually up to 5 years post baseline
Secondary outcome [6] 426929 0
Protein intake from FFQ data analysis
Timepoint [6] 426929 0
baseline, annually up to 5 years post baseline
Secondary outcome [7] 426930 0
Fat intake from FFQ data analysis
Timepoint [7] 426930 0
baseline, annually up to 5 years post baseline
Secondary outcome [8] 426931 0
Carbohydrate intake from FFQ data analysis
Timepoint [8] 426931 0
baseline, annually up to 5 years post baseline
Secondary outcome [9] 426932 0
Fibre intake from FFQ data analysis
Timepoint [9] 426932 0
baseline, annually up to 5 years post baseline
Secondary outcome [10] 426933 0
Sodium intake from FFQ data analysis
Timepoint [10] 426933 0
baseline, annually up to 5 years post baseline
Secondary outcome [11] 426934 0
Potassium intake from FFQ data analysis
Timepoint [11] 426934 0
baseline, annually up to 5 years post baseline
Secondary outcome [12] 426935 0
Phosphorus intake from FFQ data analysis
Timepoint [12] 426935 0
baseline, annually up to 5 years post baseline

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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to complete questionnaires with the aid of a researcher

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/04/2023
Date of last participant enrolment
Anticipated
26/09/2025
Actual
Date of last data collection
Anticipated
30/08/2030
Actual
Sample size
Target
612
Accrual to date
52
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25419 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 25420 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 25421 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 41161 0
4029 - Herston
Recruitment postcode(s) [2] 41163 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 41162 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 314633 0
University
Name [1] 314633 0
Queensland University of Technology
Country [1] 314633 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street, Herston, Qld 4029
Country
Australia
Secondary sponsor category [1] 316598 0
None
Name [1] 316598 0
Address [1] 316598 0
Country [1] 316598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313654 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 313654 0
Office for Research Governance & DevelopmentLevel 2, PED Building1 Hospital Boulevard, Southport, QLD, 4215
Ethics committee country [1] 313654 0
Australia
Date submitted for ethics approval [1] 313654 0
27/06/2022
Approval date [1] 313654 0
13/12/2022
Ethics approval number [1] 313654 0
HREC/2022/QGC/80735

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128894 0
A/Prof Helen MacLaughlin
Address 128894 0
School of Exercise and Nutrition Sciences
QUT Kelvin Grove
Qld 4059
Country 128894 0
Australia
Phone 128894 0
+61 7 31385799
Fax 128894 0
Email 128894 0
h.maclaughlin@qut.edu.au
Contact person for public queries
Name 128895 0
A/Prof Helen MacLaughlin
Address 128895 0
School of Exercise and Nutrition Sciences
QUT Kelvin Grove
Qld 4059
Country 128895 0
Australia
Phone 128895 0
+61 7 31385799
Fax 128895 0
Email 128895 0
h.maclaughlin@qut.edu.au
Contact person for scientific queries
Name 128896 0
A/Prof Helen MacLaughlin
Address 128896 0
School of Exercise and Nutrition Sciences
QUT Kelvin Grove
Qld 4059
Country 128896 0
Australia
Phone 128896 0
+61 7 31385799
Fax 128896 0
Email 128896 0
h.maclaughlin@qut.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants did not consent to data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20071Study protocol  h.maclaughlin@qut.edu.au



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.