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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|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|
|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.
- 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
- Decrements of 24-hour urine sodium [ Time Frame: 12 weeks after low salt diet education start ]
- Change of blood pressure with a sphygmomanometer [ Time Frame: 12 weeks after low salt diet education start ]
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
|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 firstname.lastname@example.org|