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

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ClinicalTrials.gov Identifier: NCT03396328
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

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.




Primary Outcome Measures :
  1. Decrements of 24-hour urine albumin levels [ Time Frame: 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 :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396328


Locations
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Korea, Republic of
Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jung Tak Park, M.D., Ph,D    82-2-2228-2281    jtpark@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03396328     History of Changes
Other Study ID Numbers: 4-2017-0906
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Albuminuria
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms