Clinical Trial

Effect of Access to Dietary Intervention in a Dialysis Unit

Study acronym: EFFECTdiet
Enrolling by Invitation
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Summary
Objective: The aim of this study is to explore the effect of access to individual dietary counselling by a dietitian in the dialysis unit on biochemical values (phosphorus and potassium), diet, nutritional status, quality of life (QoL) and health literacy (HL). Hypothesis: Having access to a dietitian can better laboratory values and affect dietary intake, nutritional status, QoL and HL in a positive matter. Method: Pilot cluster RCT study in three the dialysis units in Region Zealand. Clustering of people on dialysis the same day to either intervention or control group. The groups is expected to be similar regarding clinical characteristics. Primary outcome: Change in average p-phosphate Secondary outcomes: Change in average p-potassium, number of phosphate binders, number of potassium binders, HeartDiet-score, Nutritional Status, Adherence to diet (End Stage Renal Disease Adherence Questionnaire), Quality of life (Kidney Disease Quality of Life Short Form) and Health literacy (Health Literacy Questionnaire) Intervention: The intervention group receives an initial individual dietary interview, monthly follow-up and weekly access to a dietitian in the dialysis unit for four months. The control group receives usual care with referral to a dietitian when needed.
Trial Details
NCT Number NCT06996405
Lead Sponsor Zealand University Hospital
Collaborators: Steno Diabetes Center Sjaelland, The Danish Kidney Association, VIA University College, The Danish Dietetic Association
Conditions Dialysis, Diabetes, Nutritional Status, Diet Therapy
Enrollment 40 participants
Start Date 2024-11-27
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-30