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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT03396328

Collaborator

(none)

108

Enrollment

Location

Arms

24.1

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Albuminuria	Behavioral: conventional low salt education Behavioral: Intensive low salt dietary education by smartphone application	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 10, 2018

Actual Primary Completion Date :

May 12, 2020

Actual Study Completion Date :

May 12, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT03396328

Other Study ID Numbers:

4-2017-0906

First Posted:

Jan 10, 2018

Last Update Posted:

Sep 29, 2020

Last Verified:

Sep 1, 2020

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:

Additional relevant MeSH terms:

Albuminuria

Study Results

No Results Posted as of Sep 29, 2020