Adaptive Nutrition Therapy in Hemodialysis

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

Registry	NCT05469620
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, factorial, masking: none, supportive care
Enrollment	175 (Actual)
Sponsor	Inje University (Other); collaborators: Hallym University Kangnam Sacred Heart Hospital, KangWon National University Hospital, Korea University Guro Hospital, Korea University Ansan Hospital, Myongji Hospital, Korea Data Agency, Eatmapl, Daejeon Eulji University Medical Center, Seoul National University
Conditions	Renal Dialysis
Interventions	Meal, Education (Dietary supplement, other)
Dates	start 2021-10-06, primary completion 2021-12-26, completion 2022-02-28, first posted 2022-07-22, last updated 2022-07-22
Locations	1 site in South Korea

-Summary

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

Arm	Type	Interventions	Description
Control	No intervention		Receive usual care.
Education	Experimental	Other: Education	Receive nutrition education.
Meal	Experimental	Dietary Supplement: Meal	Receive meal kit.
Education and Meal	Experimental	Dietary Supplement: Meal; Other: Education	Receive both nutrition education and meal kit.

Meal (Dietary supplement): 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.
Education (Other): 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.

Potassium [4 weeks]: Serum potassium level measured from routine blood test.
Phosphate [4 weeks]: Serum phosphate level measured from routine blood test.
Malnutrition [8 weeks]: 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)

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

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* have been on hemodialysis for over 3 months

Exclusion Criteria:

* diagnosed with cancer within 5 years

Facility	City	Country	Status
Inje University Seoul Paik Hospital	Seoul	South Korea