Adaptive Nutrition Therapy in Hemodialysis

Not Applicable

Completed

• Conditions: Renal Dialysis
• Interventions: Other: Education; Dietary Supplement: Meal

• Registration Number: NCT05469620
• Lead Sponsor: Inje University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-06
• Primary Completion: 2021-12-26
• Study Completion: 2022-02-28
• Status Verified: 2022-07
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-22
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• have been on hemodialysis for over 3 months

Exclusion Criteria

• diagnosed with cancer within 5 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Education	Education	Receive nutrition education.
Education and Meal	Meal	Receive both nutrition education and meal kit.
Education and Meal	Education	Receive both nutrition education and meal kit.
Meal	Meal	Receive meal kit.

Primary Outcome Measures

Name	Time	Method
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)
Potassium	4 weeks	Serum potassium level measured from routine blood test.
Phosphate	4 weeks	Serum phosphate level measured from routine blood test.

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Inje University Seoul Paik Hospital; 🇰🇷 Seoul, Korea, Republic of