Clinical trial NCT06996405: Effect of Access to Dietary Intervention in a Dialysis Unit
Official title: EFFECT Diet - Cluster RCT and Qualitative Inquiry
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dialysis
Diabetes
Nutritional Status
Diet Therapy
Keywords: Dietary intervention
Dietitian
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Sjaelland
name: The Danish Kidney Association
name: VIA University College
name: The Danish Dietetic Association
First posted: 2025-05-30
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Research question:

What is the effect of access to dietary treatment in people receiving dialysis treatment on biochemical values (phosphorus and potassium), diet, nutritional status, quality of life and health literacy? 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 the dialysis units in Holbæk and Slagelse in Region Zealand, Denmark. Clustering of people on dialysis the same day to either intervention or control group. The groups is expected to be similar regarding clinical characteristics. A pilot project will be conducted in 2024 in the dialysis units in Slagelse and Holbæk.

Data collection:

Both groups:

* Patient characteristics (at the beginning of project): Age and gender, height, medical diagnosis, socioeconomic data (income, job, education, partner status) and dialysis vintage.
* Clinical Data (before and after the intervention, and at 6 and 12 month after the intervention period): Biochemical values (phosphate, potassium, urea, albumin, PTH), anthropometric measures (dry weight, actual weight), medication, ultrafiltration, and number of contacts with dietitian.
* Questionnaires and tests (collected before and after the intervention): Body composition (fat, fat-free mass, water), Nutritional status, Intake (HeartDiet Questionnaire), Quality of Life (KDQOL-SF), Health Literacy (HLQ), and previous dietary treatment.

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 (nutritional screening), Adherence to diet (End Stage Renal Disease Adherence Questionnaire, ESRD-AQ-score), Quality of life (Kidney Disease Quality of Life Short Form, KDQOL-SF-score) and Health literacy (Health Literacy Questionnaire, HLQ-score)

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 individualized dietary treatment based on the patient's preferences and needs according to the Nutrition Care Process. It is carried out according to the practical guidelines from the Danish Dietetic Association on dietary treatment of chronic kidney disease. The dietary treatment uses a dialogic and person-centered approach The intervention is described in the protocol using the TIDieR framework. The control group receives usual care with referral to a dietitian when needed.

Statistics:

The average phosphorus level and standard deviation after a diet intervention was 1.58 ± 0.32 mmol/l, therefore using 0.32 mmol/l in calculation of sample size. An implementation of guidelines and a systematic review showed a difference in phosphosus levels between intervention and control group of 0.23 and 0.30 mmol/l respectively.

Calculation of sample size using "Sample Size Calculator (clincalc.com)". Using the values mentioned above, a power of 80% and a significance of 5% shows a sample size of 18-30 people in each group to show a significant change in phosphorus levels.

Comparison of changes in average values using unpaired t-test, including endpoints of p-phosphorous and p-potassium, QoL-score and health literacy score. For dichotomous endpoints such as nutritional score, comparison of the percentage of the groups within and without specific limits. Data analysis with intention-to-treat and statistical calculations by a person not familiar with the groups.

Eligibility criteria: Inclusion criteria:

* Able to understand Danish
* Chronic dialysis treatment (min. 3 month)

Exclusion criteria:

* Dementia
* Not able to sign a consent form
* Expected short duration of life, eg. terminal cancer

Primary outcomes:
measure: Average phosphate
timeFrame: At baseline and after 5 month at the end of the intervention period (last phosphate value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)
Secondary outcomes:
measure: Phosphate-level
timeFrame: At baseline and after 5 month at the end of the intervention period (last phosphate value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)
measure: Phosphate-level
timeFrame: At baseline and after 5 month at the end of the intervention period (last phosphate value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)
measure: Phosphate binders
timeFrame: At baseline, changes within the intervention period, after 5 month at the end of the intervention period, and 6 and 12 month after the last day of the intervention
measure: Average potassium
timeFrame: At baseline and after 5 month at the end of the intervention period (last potassium value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)
measure: Potassium-level
timeFrame: At baseline and after 5 month at the end of the intervention period (last potassium value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)
measure: Potassium-level
timeFrame: At baseline and after 5 month at the end of the intervention period (last potassium value before termination of intervention), and 6 and 12 month post-intervention (counting from last day of intervention)
measure: Potassium binders
timeFrame: At baseline, changes within the intervention period, after 5 month at the end of the intervention period, and 6 and 12 month after the last day of the intervention
measure: Nutritional Status
timeFrame: At baseline and after 5 month at the end of the intervention period
measure: Nutritional intake
timeFrame: At baseline and after 5 month at the end of the intervention period
measure: Quality of Life-score
timeFrame: At baseline and after 5 month at the end of the intervention period
measure: Adherence-score
timeFrame: At baseline and after 5 month at the end of the intervention period
measure: Symptom-score
timeFrame: At baseline and after 5 month at the end of the intervention period
measure: Health Literacy Questionnaire-score
timeFrame: At baseline and after 5 month at the end of the intervention period
Other outcomes:
Locations:
city: Holbæk
country: Denmark
facility: Holbæk Dialysis Unit
city: Næstved
country: Denmark
facility: Næstved Dialysis Unit
city: Slagelse
country: Denmark
facility: Slagelse Dialysis Unit
Study officials:
affiliation: Zealand University Hospital
name: Sofie Wendelboe
role: PRINCIPAL_INVESTIGATOR
References: