Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000057583
Ethics application status
Approved
Date submitted
8/12/2023
Date registered
24/01/2024
Date last updated
28/04/2024
Date data sharing statement initially provided
24/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Kidney-Healthy Eating and Lifestyle Program (Kidney-HELP): Randomised Feasibility Study
Scientific title
Kidney-Healthy Eating and Lifestyle Program (Kidney-HELP): Randomised Feasibility Study in Adults with Chronic Kidney Disease
Secondary ID [1] 310830 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Kidney-HELP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 331831 0
Condition category
Condition code
Renal and Urogenital 328570 328570 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the high-intensity intervention group will receive usual care as well as attend the Kidney-HELP, which consists of:
• Attending the pre-existing HELP program (2-hour weekly sessions for 7 weeks), HELP was developed from evidence-based clinical practice guidelines and is based on theoretical frameworks to promote behaviour change (Cognitive Behaviour Therapy and Social Cognitive Theory). The program is delivered by an accredited practicing dietitian and clinical psychologist.
• 2 additional sessions covering kidney-specific content delivered by a dietitian, and
• Kidney-HELP workbook.

This Kidney-HELP workbook has been modified from the original HELP workbook to include kidney-specific information to improve participants' understanding of the diet-disease relationship. The workbook contains information on goal setting, self-monitoring, the Australian Guide to Healthy Eating & Heart Foundation dietary recommendations, strategies to follow a healthy dietary pattern, mindful eating and links to recipes. Participants will work through the Kidney-HELP workbook during the first 7 sessions of the program.

The Kidney-HELP is outlined below:
Week 1/Session 1: Getting Started
Week 2/Session 2: Enjoying eating for health and wellbeing
Week 3/Session 3: Planning for better health
Week 4/Session 4: Supermarket savvy
Week 5/Session 5: Mood and food
Week 6/Session 6: Enjoying food
Week 7/Session 7: Staying on track
Week 8-9/Session 8: Salt group
Week 10-11/Session 9: Eating out and recipe modification

Participants will have the option to attend the group program either face-to-face or by telehealth. Attendance will be recorded at each session.
Intervention code [1] 327243 0
Lifestyle
Intervention code [2] 327659 0
Behaviour
Intervention code [3] 327660 0
Treatment: Other
Comparator / control treatment
Participants randomised to the low-intensity intervention group will receive the Kidney-HELP workbook in addition to usual care from the kidney care team. The low-level intervention group will be instructed to work through the workbook in their own time, completing a chapter per week for the first 7 weeks. Participants will complete a survey at the end of 7 weeks to monitor adherence to the workbook.
Control group
Active

Outcomes
Primary outcome [1] 336380 0
Feasibility (composite outcome)
Timepoint [1] 336380 0
Recruitment will be measured at the last participant is recruited into the trial.
Retention and adherence will be measured at 12 weeks after the commencement of the intervention.
Primary outcome [2] 336381 0
Acceptability
Timepoint [2] 336381 0
Participants will complete semi-structured interviews after the completion of the study at 12 weeks post commencement of intervention.
Secondary outcome [1] 428103 0
Dietary self-efficacy
Timepoint [1] 428103 0
At baseline (0 weeks) and 12 weeks post commencement of intervention
Secondary outcome [2] 428104 0
Health-related quality of life
Timepoint [2] 428104 0
At baseline (0 weeks) and 12 weeks post commencement of intervention
Secondary outcome [3] 428105 0
Diet quality
Timepoint [3] 428105 0
At baseline (0 weeks) and 12 weeks post commencement of intervention
Secondary outcome [4] 430150 0
Self-efficacy
Timepoint [4] 430150 0
At baseline (0 weeks) and 12 weeks post commencement of intervention

Eligibility
Key inclusion criteria
a) Adults aged with CKD stages 3a-4 (15 – 59mL/min/1.732 for longer than 3 months)
b) Under the care of a Metro North nephrologist,
c) Able to provide informed consent.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Non-English speaking or unable to read and write in English,
b) Pregnancy, breastfeeding or planning to become pregnant in the next 6 months,
c) Have a cognitive impairment that would prevent participation,
d) Significant psychiatric or psychological disorder including the presence of an active eating disorder or purging behaviours.
e) Malnourished (Subjective Global Assessment B or C)
f) Receiving palliative, or
g) Currently taking part in another clinical trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
1/04/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
40
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315077 0
Hospital
Name [1] 315077 0
Royal Brisbane and Women's Hosptial
Country [1] 315077 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
149 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country
Australia
Secondary sponsor category [1] 317095 0
Hospital
Name [1] 317095 0
Royal Brisbane and Women's Hospital
Address [1] 317095 0
Butterfield Street, Herston, Queensland, 4059
Country [1] 317095 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314024 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 314024 0
Block 7, Level 7 Butterfield Street, Herston, QLD 4029
Ethics committee country [1] 314024 0
Australia
Date submitted for ethics approval [1] 314024 0
01/11/2023
Approval date [1] 314024 0
15/01/2024
Ethics approval number [1] 314024 0

Summary
Brief summary
This study aims to establish the feasibility, acceptability and fidelity of a high- and low-intensity self-efficacy-based dietary intervention for adults with CKD for a future large-scale clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130158 0
A/Prof Helen MacLaughlin
Address 130158 0
School of Exercise and Nutrition Sciences, Queensland University of Technology, 149 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country 130158 0
Australia
Phone 130158 0
+6173138 5799
Fax 130158 0
Email 130158 0
erynn.mcauley@hdr.qut.edu.au
Contact person for public queries
Name 130159 0
Miss Erynn McAuley
Address 130159 0
School of Exercise and Nutrition Sciences, Queensland University of Technology, 149 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country 130159 0
Australia
Phone 130159 0
+6173138 5799
Fax 130159 0
Email 130159 0
erynn.mcauley@hdr.qut.edu.au
Contact person for scientific queries
Name 130160 0
Miss Erynn McAuley
Address 130160 0
School of Exercise and Nutrition Sciences, Queensland University of Technology, 149 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country 130160 0
Australia
Phone 130160 0
+6173138 5799
Fax 130160 0
Email 130160 0
erynn.mcauley@hdr.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


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
No additional documents have been identified.