None listed
Conditions
Brief summary
Diet and lifestyle have been identified as the leading modifiable risk factors in chronic disease, of particular relevance considering the cardiovascular burden in chronic kidney disease (CKD). People with CKD identify diet and lifestyle programs for preventing deteriorating kidney function as their highest ranked research priorities. However, dietary change can be considered complex for patients with CKD. Patients are frequently advised on the manipulation of single nutrients, which often conflicts with associated co-morbidities and advice from other health professionals. Evidence from our recent systematic reviews have indicated: healthy eating patterns in CKD are associated with lower risk of mortality; current evidence from clinical trials to support dietary change in CKD are limited. CKD patients prefer a repeated, coaching approach with frequent feedback to support dietary change; and telehealth strategies enhance adherence to dietary change compared with traditional models. This randomised controlled trial aims to determine the feasibility, patient acceptance, and clinical impact of telephone-based contact with additional or standalone tailored text messages compared with usual care to support dietary adherence among patients with chronic kidney disease.
Interventions
Brief name: ENTICE Intervention
Materials and mode of delivery: Telehealth coaching delivered using mobile phones, and a workbook to be provided to all participants. Workbook content is based on the Australian Dietary Guidelines for Adults and contains self-monitoring checklists for salt and food groups serves each day. Workbooks also contain sections to record goals and progress towards those goals.
Procedure: Telehealth coaching aimed at supporting a dietary pattern that includes reduced di
Brief name: ENTICE Intervention Materials and mode of delivery: Telehealth coaching delivered using mobile phones, and a workbook to be provided to all participants. Workbook content is based on the Australian Dietary Guidelines for Adults and contains self-monitoring checklists for salt and food groups serves each day. Workbooks also contain sections to record goals and progress towards those goals. Procedure: Telehealth coaching aimed at supporting a dietary pattern that includes reduced dietary sodium intake and adheres to Australian Dietary Guidelines. Using a patient-centred approach, intervention delivery is based on empirical evidence that supports a focus on self-management; repeated support and two-way feedback and monitoring and underpinned by Social Cognitive Theory. Each call is anticipated to last 30-45 minutes. Mode of delivery and number of contacts: Phase 1, Week 0-12: Telehealth coaching (fortnightly coaching calls with text messages scheduled twice per fortnight between calls); Phase 2, Week 12-24: Tailored text messages (2 x 10 minute tailoring phone calls to determine the number, frequency and content of text messages to be provided based on participant’s goals and perceived barriers, educational tips, and reinforcement). Who and Location: Coaches will be accredited practicing dietitians with training in renal nutrition and will deliver the intervention from a central calling centre within the local health service. Personalisation: Educational content will be personalised to the participant’s goal for dietary change and associated co-morbidities, which will be continuously assessed at baseline and at each coaching call. Fidelity: standardised training to coaches in behaviour change, motivational interviewing and renal nutrition and standard call content checklists. Regular peer-review of counselling and fortnightly case discussions with the lead investigator will support counselors in intervention delivery and standardisation.
Sponsors
AKTN
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 No maximum
Healthy volunteers
No
Inclusion criteria
a) Adults (>18 years of age) with stage III-IV CKD (eGFR 15-59 ml/min/1.73m2); b) Have current access to a mobile phone; and c) Provide written informed consent.
Exclusion criteria
a) Treated with dialysis or kidney transplantation; b) Deemed unsafe to participate by their nephrologist; or c) Non-English speaking; and/or unable to read and write in English.
Outcome results
None listed