AlbuminuriaNCT03396328
Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria
A study testing conventional low salt education and Intensive low salt dietary education by smartphone application in people with Albuminuria, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Albuminuria
- What is being tested?
- conventional low salt education and Intensive low salt dietary education by smartphone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2018to 12 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Nephrology, Department of Internal Medicine Yonsei University College of Medicine
Seoul, 03722
About this study
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.
- Conditions
- Albuminuria
- Being tested
- conventional low salt education, Intensive low salt dietary education by smartphone application
- Medical subject headings
- Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional low salt educationBehavioural
conventional low salt education
Intensive low salt dietary education by smartphone applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional education | Active comparator | Not described Receives: Behavioral: conventional low salt education |
| Low salt dietary education by smartphone application | Experimental | Not described Receives: Behavioral: Intensive low salt dietary education by smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrements of 24-hour urine albumin levels
Decrements of 24-hour urine albumin levels 12 weeks after low salt diet education
Measured: 12 weeks after low salt diet education start
Secondary outcomes (2)
Decrements of 24-hour urine sodium
Measured: 12 weeks after low salt diet education start
Change of blood pressure with a sphygmomanometer
Measured: 12 weeks after low salt diet education start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start10 May 2018
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlbuminuriaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396328
- Sponsor's protocol ID
- 4-2017-0906
- Status last verified
- Sep 2020
- First submitted
- 4 Jan 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Low-Salt Diet Education by Mobile Application on Albuminuria
- ClinicalTrials.gov ID
- NCT03396328
- Acronym / sponsor ID
- 4-2017-0906
- Conditions
- Albuminuria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional education | Active comparator | Behavioral: conventional low salt education |
| Low salt dietary education by smartphone application | Experimental | Behavioral: Intensive low salt dietary education by smartphone application |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Age under 18 or over 66
- Uncontrolled hypertension (BP>160/110 mmHg)
- Pregnancy within 6 months
- Serum potasium > 5.5 mEq/L
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional low salt educationconventional low salt education | Behavioural | Conventional education |
| Intensive low salt dietary education by smartphone applicationParticipants 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. | Behavioural | Low salt dietary education by smartphone application |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional low salt education and Intensive low salt dietary education by smartphone application in people with Albuminuria, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrements of 24-hour urine albumin levels (time frame: 12 weeks after low salt diet education start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.