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Kidney-Healthy Eating and Lifestyle Program (Kidney-HELP): Randomised Feasibility Study

Kidney-Healthy Eating and Lifestyle Program (Kidney-HELP): Randomised Feasibility Study in Adults with Chronic Kidney Disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000057583
Acronym
Kidney-HELP
Enrollment
51
Registered
2024-01-24
Start date
2024-04-01
Completion date
2024-10-01
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 psycho

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.

Sponsors

Queensland University of Technology
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026