Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria

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.

Study Overview

• Status: Completed
• Conditions: Albuminuria
• Intervention / Treatment: Behavioral: conventional low salt education; Behavioral: Intensive low salt dietary education by smartphone application

Detailed Description

This is an pen-label, case-control, randomized clinical trial.

• Run-in period (8 weeks) : before 8 weeks of study initiation, all of the patients have to stop all RAAS blockers or diuretics and switch to antihypertensive agents of other categories such as calcium channel blockers.
• 0-8 weeks : After run-in period, the patients complete laboratory examination and a dish frequency questionnaire. From 0 weeks, all participants will be prescribed valsartan 80mg per day until the end of study.
• 8-16 weeks : After 8 weeks, the patients will be randomly assigned to receive an low-salt dietary intervention after second laboratory examination.

Usual education : Conventional education at an outpatient clinic Intensive education : Low salt diet education through Smartphone app

The patients in the conventional education group will receive routine CKD education once at an outpatient clinic. Otherwise, the patients in the intensive education group will be trained low salt diet through smartphone app.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional education	Behavioral: conventional low salt education; conventional low salt education
EXPERIMENTAL: Low salt dietary education by smartphone application	Behavioral: Intensive low salt dietary education by smartphone application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2018
• Primary Completion (ACTUAL): May 12, 2020
• Study Completion (ACTUAL): May 12, 2020

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (ACTUAL): January 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Proteinuria; Albuminuria
• Other Study ID Numbers: 4-2017-0906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No