Adaptive Nutrition Therapy in Hemodialysis

Study Overview
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Brief Summary
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8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit.

Official Title
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Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of Adaptive Nutrition Therapy in Hemodialysis Patients

Conditions
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Renal Dialysis

Intervention / Treatment
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* Dietary Supplement: Meal
* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have been on hemodialysis for over 3 months Exclusion Criteria: diagnosed with cancer within 5 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2 by 2 factorial design, consisting of nutrition education and meal kit prescription.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Receive usual care. | |
| Experimental: Education<br>Receive nutrition education. | Other: Education<br>* Leaflet or video education materials on seven nutrition-related topics are provided, based on predefined logic. Materials are sent throughout the week, via SMS links.<br>|
| Experimental: Meal<br>Receive meal kit. | Dietary Supplement: Meal<br>* Either a meal kit low in sodium, potassium, and phosphorus; or a meal kit low in sodium only is provided based on predefined logic. Meal kits are delivered in bulk twice a week, meant to replace one meal a day.<br>|
| Experimental: Education and Meal<br>Receive both nutrition education and meal kit. | Dietary Supplement: Meal<br>* Either a meal kit low in sodium, potassium, and phosphorus; or a meal kit low in sodium only is provided based on predefined logic. Meal kits are delivered in bulk twice a week, meant to replace one meal a day.<br>Other: Education<br>* Leaflet or video education materials on seven nutrition-related topics are provided, based on predefined logic. Materials are sent throughout the week, via SMS links.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potassium | Serum potassium level measured from routine blood test. | 4 weeks | 
| Phosphate | Serum phosphate level measured from routine blood test. | 4 weeks | 
| Malnutrition | 10-item nutritional status measured with Malnutrition Inflammation Score. Scores range from 0 to 30, higher value corresponding to worse outcome (higher risk of malnutrition) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | 21-item depression score measured with Korean-Beck Depression Inventory. Scores rnage from 0 to 63, higher value corresponding to worse outcome (severe depression). | 8 weeks | 
| Self-Efficacy | 10-item Self-Efficacy score for hemodialysis patients. Scores range from 10 to 40, higher values corresponding to better outcome (higher self-efficacy). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition