NCT05469620

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 20, 2022

Last Update Submit

July 20, 2022

Conditions

Renal Dialysis

Keywords

nutrition

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Depression

    8 weeks

  • Self-Efficacy

    8 weeks

Study Arms (4)

Control

NO INTERVENTION

Receive usual care.

Education

EXPERIMENTAL

Receive nutrition education.

Other: Education

Meal

EXPERIMENTAL

Receive meal kit.

Dietary Supplement: Meal

Education and Meal

EXPERIMENTAL

Receive both nutrition education and meal kit.

Dietary Supplement: MealOther: Education

Interventions

MealDIETARY_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 MealMeal
EducationOTHER

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.

EducationEducation and Meal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have been on hemodialysis for over 3 months

You may not qualify if:

  • diagnosed with cancer within 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University Seoul Paik Hospital

Seoul, 100-032, South Korea

Location

MeSH Terms

Interventions

MealsEducational Status

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: 2 by 2 factorial design, consisting of nutrition education and meal kit prescription.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 20, 2022

First Posted

July 22, 2022

Study Start

October 6, 2021

Primary Completion

December 26, 2021

Study Completion

February 28, 2022

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)