Adaptive Nutrition Therapy in Hemodialysis

Sponsor

Inje University (Other)

Overall Status

Completed

CT.gov ID

NCT05469620

Collaborator

Hallym University Kangnam Sacred Heart Hospital (Other), KangWon National University Hospital (Other), Korea University Guro Hospital (Other), Korea University Ansan Hospital (Other), Myongji Hospital (Other), Korea Data Agency (Other), Eatmapl (Other), Daejeon Eulji Medical Center (Other), Seoul National University (Other)

175

Enrollment

Location

Arms

4.8

Actual Duration (Months)

36.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis	Dietary Supplement: Meal Other: Education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

175 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

2 by 2 factorial design, consisting of nutrition education and meal kit prescription.2 by 2 factorial design, consisting of nutrition education and meal kit prescription.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 6, 2021

Actual Primary Completion Date :

Dec 26, 2021

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Receive usual care.
Experimental: Education Receive nutrition education.	Other: Education 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.
Experimental: Meal Receive meal kit.	Dietary Supplement: Meal 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.
Experimental: Education and Meal Receive both nutrition education and meal kit.	Dietary Supplement: Meal 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. Other: Education 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.

Outcome Measures

Primary Outcome Measures

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)

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

have been on hemodialysis for over 3 months

Exclusion Criteria:

diagnosed with cancer within 5 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Seoul Paik Hospital	Seoul		Korea, Republic of	100-032

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoseok Koo, Director, Inje University

ClinicalTrials.gov Identifier:

NCT05469620

Other Study ID Numbers:

DNET_CKD nutrition 1.0

First Posted:

Jul 22, 2022

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hoseok Koo, Director, Inje University

nutrition

Study Results

No Results Posted as of Jul 22, 2022