Adaptive Nutrition Therapy in Hemodialysis

NCT ID: NCT05469620

Last Updated: 2022-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2022-02-28

Brief Summary

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

Detailed Description

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Conditions

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Renal Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control

Receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Education

Receive nutrition education.

Group Type EXPERIMENTAL

Education

Intervention Type 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.

Meal

Receive meal kit.

Group Type EXPERIMENTAL

Meal

Intervention Type 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 and Meal

Receive both nutrition education and meal kit.

Group Type EXPERIMENTAL

Meal

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* have been on hemodialysis for over 3 months

Exclusion Criteria

* diagnosed with cancer within 5 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hallym University Kangnam Sacred Heart Hospital

OTHER

Sponsor Role collaborator

KangWon National University Hospital

OTHER

Sponsor Role collaborator

Korea University Guro Hospital

OTHER

Sponsor Role collaborator

Korea University Ansan Hospital

OTHER

Sponsor Role collaborator

Myongji Hospital

OTHER

Sponsor Role collaborator

Korea Data Agency

UNKNOWN

Sponsor Role collaborator

Eatmapl

UNKNOWN

Sponsor Role collaborator

Daejeon Eulji Medical Center

UNKNOWN

Sponsor Role collaborator

Seoul National University

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role lead

Responsible Party

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Hoseok Koo

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inje University Seoul Paik Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DNET_CKD nutrition 1.0

Identifier Type: -

Identifier Source: org_study_id

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