Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria
Condition: Albuminuria
MeSH terms: Albuminuria
Study type: Interventional

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.
    

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.
    

Intervention name(s): conventional low salt education; Intensive low salt dietary education by smartphone application
Intervention type(s): Behavioral; Behavioral
Intervention description(s): conventional low salt education; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care