NCT03396328

Brief Summary

Albuminuria is a known risk factor for cardiovascular disease (CVD), chronic kidney disease (CKD) progression, all cause mortality. Inhibition of the renin-angiotension-aldosterone system (RAAS) plays an important role in the reduction of albuminuria and preservation of renal function in patients with CKD and it is known that the daily intakes of sodium have a significant effect on the activity of RAAS. Dietary sodium restriction has been shown to enhances the blood pressure, albuminuria, and renal function preservation. Furthermore, recent study has shown that intensive low-salt dietary education reduces albuminuria in patients with CKD. The average sodium intake of Koreans is 4,791 mg/d, which is higher than other countries. It is difficult for medical staff in Korea to invest enough time in low salt diet. Recently, the development of health-related applications (apps) has been carried out worldwidely, and researches on lifestyle improvement using apps have been actively studied. However, there is no research yet on whether intensive education using an apps can affect lifestyle habits and thus changes in actual new features. Smartphone apps may provide an alternative to resource-intensive low salt diet-education. Therefore, this study aims to investigate the effect of intensive low salt diet training on the changes of albuminuria using application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Typical duration 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

First Submitted

Initial submission to the registry

January 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 10, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

January 4, 2018

Last Update Submit

September 28, 2020

Conditions

Albuminuria

Outcome Measures

Primary Outcomes (1)

  • Decrements of 24-hour urine albumin levels

    Decrements of 24-hour urine albumin levels 12 weeks after low salt diet education

    12 weeks after low salt diet education start

Secondary Outcomes (2)

  • Decrements of 24-hour urine sodium

    12 weeks after low salt diet education start

  • Change of blood pressure with a sphygmomanometer

    12 weeks after low salt diet education start

Study Arms (2)

Conventional education

ACTIVE COMPARATOR
Behavioral: conventional low salt education

Low salt dietary education by smartphone application

EXPERIMENTAL
Behavioral: Intensive low salt dietary education by smartphone application

Interventions

conventional low salt educationBEHAVIORAL

conventional low salt education

Conventional education
Intensive low salt dietary education by smartphone applicationBEHAVIORAL

Participants are provided with information on food and recipe, which allows them to record daily meals in their applications. Through the mobile application, the participants receive information on daily salt intake. Based on this information, the clinical nutritionist coach sets a goal for low salt diet and provides feedback to the patients through the mobile application. The clinical nutritionist coach checks the activity of the user more than twice a week and sends in-app messages to maintain compliance.

Low salt dietary education by smartphone application

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age : 19-65
  • Underlying hypertension or antihypertensive medication , or Systolic blood pressure ≧ 140 mmHg or Diastolic blood pressure ≧ 90
  • Modification of Diet in Renal Disease study (MDRD) eGFR ≧ 30 ml/min per 1.73m2
  • Random urine albumin-to-creatinine ratio ≧ 30 mg/g
  • Smartphone ownership

You may not qualify if:

  • Age under 18 or over 66
  • Uncontrolled hypertension (BP\>160/110 mmHg)
  • Pregnancy within 6 months
  • Serum potasium \> 5.5 mEq/L
  • malignancy
  • a diagnosis of CVD (cerebral infarction, hemorrhagic infarction, acute myocardial infarction or unstable angina, coronary angioplasty, or coronary artery bypass surgery) within the last 6 months
  • Contraindication to angiotensin II receptor blocker
  • life expectancy less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Albuminuria

Condition Hierarchy (Ancestors)

ProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 10, 2018

Study Start

May 10, 2018

Primary Completion

May 12, 2020

Study Completion

May 12, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)