Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria
Primary Purpose
Albuminuria
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
conventional low salt education
Intensive low salt dietary education by smartphone application
Sponsored by
About this trial
This is an interventional supportive care trial for Albuminuria
Eligibility 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
Sites / Locations
- Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional education
Low salt dietary education by smartphone application
Arm Description
Outcomes
Primary Outcome Measures
Decrements of 24-hour urine albumin levels
Decrements of 24-hour urine albumin levels 12 weeks after low salt diet education
Secondary Outcome Measures
Decrements of 24-hour urine sodium
Change of blood pressure with a sphygmomanometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03396328
Brief Title
Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria
Official Title
Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
May 12, 2020 (Actual)
Study Completion Date
May 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Albuminuria
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional education
Arm Type
Active Comparator
Arm Title
Low salt dietary education by smartphone application
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
conventional low salt education
Intervention Description
conventional low salt education
Intervention Type
Behavioral
Intervention Name(s)
Intensive low salt dietary education by smartphone application
Intervention Description
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 Measure Information:
Title
Decrements of 24-hour urine albumin levels
Description
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 Outcome Measure Information:
Title
Decrements of 24-hour urine sodium
Time Frame
12 weeks after low salt diet education start
Title
Change of blood pressure with a sphygmomanometer
Time Frame
12 weeks after low salt diet education start
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria
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