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CompletedNCT03396328Updated Sep 29, 2020

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

An interventional study of conventional low salt education and Intensive low salt dietary education by smartphone application in Albuminuria, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Yonsei University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Albuminuria

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03

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Active comparator
    Conventional education

    Behavioral: conventional low salt education

  • Experimental
    Low salt dietary education by smartphone application

    Behavioral: Intensive low salt dietary education by smartphone application

Interventions

  • Behavioralconventional low salt education

    conventional low salt education

  • BehavioralIntensive 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.

05

What researchers measure

Primary outcomes

  1. Decrements of 24-hour urine albumin levels

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

    Time frame: 12 weeks after low salt diet education start

Secondary outcomes

  1. Decrements of 24-hour urine sodium

    Time frame: 12 weeks after low salt diet education start

  2. Change of blood pressure with a sphygmomanometer

    Time frame: 12 weeks after low salt diet education start

06

Study locations

1 site
  • Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
    Seoul, 03722, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03396328
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jan 10, 2018
Start date
May 10, 2018
Primary completion
May 12, 2020
Completion
May 12, 2020
Last update
Sep 29, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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