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ENROLLING BY INVITATION
NCT06996405
NA

Effect of Access to Dietary Intervention in a Dialysis Unit

Sponsor: Zealand University Hospital

View on ClinicalTrials.gov

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.

Official title: EFFECT Diet - Cluster RCT and Qualitative Inquiry

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-11-27

Completion Date

2026-09-30

Last Updated

2025-05-30

Healthy Volunteers

No

Interventions

OTHER

Access to dietary treatment

Dietary treatment using current nutrition guidelines, dialogic communication and Nutrition Care Process repeatedly by weekly access to a dietitian for four month.

Locations (3)

Holbæk Dialysis Unit

Holbæk, Denmark

Næstved Dialysis Unit

Næstved, Denmark

Slagelse Dialysis Unit

Slagelse, Denmark