HypertensionNCT04764253
Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients
A study testing Modified Sodium Watcher Program + Digital Self-Monitoring in people with Hypertension, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease. A vast array of efforts have tried to reduce sodium consumption based on evidence indicating a public health benefit. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Modified Sodium Watcher Program + Digital Self-Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2021to 30 Sep 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications.
- Smartphone with a data plan
- Valid email address
- Willing and able to participate in online study videoconferencing visits (Zoom)
- Reads and writes in English
Who cannot join
- Participating in another related research study
- Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
- Active cancer
- Recent hospitalization due to psychiatric condition or event
- Pregnancy or breastfeeding - current or planned during the study period
- Documented dementia
Show all 9Show fewer
- Prisoners
- Diabetes Diagnosis
- Heart Failure Diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease. A vast array of efforts have tried to reduce sodium consumption based on evidence indicating a public health benefit. Yet this benefit has been questioned, mainly based on studies showing variability in individual responses to a sodium-restricted diet (SRD). The effects of an SRD on blood pressure vary, and adherence to an SRD is not optimal. The original Sodium Watchers Program (R01NR012967) was developed and implemented by Dr. Misook Chung (University of Kentucky). In this pilot study, the modified Sodium Watchers Program will propose improving adherence to an SRD through education and digital self-monitoring for daily sodium intake and blood pressure.
In addition, few studies have examined individuals' metabolic responses to the SRD. In a secondary analysis, we further will examine genetic variants associated with salt sensitivity and whether such a genetic component is associated with sodium excretion and BP control.
A total of 40 hypertensive patients will be randomly assigned to the intervention (n=20) or control group (n=20). The intervention group will receive 8-week education sessions remotely using a video conferencing program. All participants will collect a 24-hour urine specimen for sodium excretion and a total of 4.0ml of peripheral blood will be drawn for salt sensitivity during baseline visit. All participants will be asked to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor.
- Conditions
- Hypertension
- Being tested
- Modified Sodium Watcher Program + Digital Self-Monitoring, Usual care + Digital Self-Monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Sodium Watcher Program + Digital Self-MonitoringBehavioural
Participants randomized to the experimental group will be asked to follow the modified Sodium Watchers Program intervention along with goal setting for low salt foods. Each participant will be registered to assign a unique ID in the Connected Health Platform developed by the Center on Smart and Connected Health Technologies at UT Health Science Center San Antonio and each account from the individuals' wireless and wearable devices (Fitbit and BP monitor) will be connected to his or her unique ID through this platform. Participants will be instructed to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor. Through the Connected Health Platform, the Fitbit app and BP monitor will transmit the data of the intervention group to the research team.
Usual care + Digital Self-MonitoringBehavioural
Participants randomized to the control group will be asked to follow usual care which is based on their routine medical and nursing care for hypertension that consists of a recommendation to follow a sodium-restricted diet and take medications as prescribed. The participants will receive wireless and wearable devices (Fitbit wristband, BP monitor). Each participant will be registered to assign a unique ID in the Connected Health Platform at the baseline and each account from the individual's wireless and wearable devices (Fitbit and BP monitor) will be connected to their unique ID through this platform. Participants will be instructed to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor.
| Study group | Role | What they receive |
|---|---|---|
| Modified Sodium Watcher Program + Digital Self-Monitoring | Experimental | Not described Receives: Behavioral: Modified Sodium Watcher Program + Digital Self-Monitoring |
| Usual care + Digital Self-Monitoring | Active comparator | Not described Receives: Behavioral: Usual care + Digital Self-Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure over time
Blood pressure (BP) will be measured using a Vital Signs Monitor 300 Series model (WelchAllyn, US). The midsection circumference of the dominant upper arm will be measured with a tape measure, and the proper sized cuff will be selected accordingly. Systolic and diastolic BP will be measured in the dominant arm twice with a 2-minute rest period between measures; two measures will be averaged.
Measured: Up to 8 weeks
Change in adherence to sodium restricted diet over time
Participants will complete a 24-hour urinary sodium excretion test at baseline and at 8 weeks after the intervention is completed. 24-hour urinary sodium excretion (mg excreted/day) will be tested by collecting all urine excreted over 24 hours. Participants are asked to note the time when they start in a written log, then discard the first urine after that time. They will then collect all urine excreted over the course of the next 24 hours, noting down the time and amount excreted each time in the written log. Urine is stored in a container and does not need refrigeration. 24-hour urine sodium samples will be analyzed by the Center for Renal Precision Medicine laboratory.
Measured: Up to 8 weeks
Secondary outcomes (4)
Adherence to dietary sodium intake monitoring
Adherence to dietary sodium intake monitoring will be monitored using Fitbit companion mobile dietary app. The Fitbit app is intended as an intervention tool to enhance self-monitoring and promote adherence, not a reliable assessment tool for dietary sodium intake (24-hour urinary samples will be used for that purpose as described in outcomes section). Each subject will be registered to assign a unique ID in the platform developed by the Center on Smart and Connected Health Technologies at UT Health San Antonio, and each account from the individuals' Fitbit will be connected to his or her unique ID through this platform. Subjects will be instructed to log their food intake in real-time. Percentage of days that subject log his or her meal in the dietary app with a calorie intake of over 1000 will be used to measure adherence to dietary sodium intake monitoring.
Measured: Up to 8 weeks
Adherence to In-home BP monitoring
Adherence to In-home BP monitoring will be measured by the percentage of days that subject log in-home BP using a wireless and automatic BP monitor device (Omron 7 Series Upper Arm BP Monitor). It has a range of 0 to 299 mmHg for BP and 40 to 180 beats per minute (bpm) for heart rate (HR). The cuff is inflated using an electric pump and deflated by means of a pressure release valve. After each measurement, the SBP, DBP, and HR are shown on the LCD screen. The device can also display a symbol on the screen indicating an irregular heartbeat detected during measurement of SBP and DBP. Each subject will be registered to assign a unique ID in the Connected Health Platform and each account from the individuals' Omron mobile app will be connected to his or her unique ID through this platform. Subjects will be instructed to measure BP while in a sitting position and transfer the BP data to Omron mobile app using a wireless and automatic BP monitor device.
Measured: Up to 8 weeks
Attendance at education sessions
Attendance at education sessions will be measured by number of attended sessions for the 8-week education sessions in intervention group.
Measured: Up to 8 weeks
Retention rate
Retention rate will be measured by the percentage of subjects who come to the follow-up visit (8 weeks).
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start11 Feb 2021
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Jisook Ko, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764253
- Sponsor's protocol ID
- HSC20200504H
- Other IDs
- KL2TR002646
- Status last verified
- Jun 2024
- First submitted
- 17 Feb 2021
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this time.
Publications
Ko J, Wang J, Chung ML, Sharma K. Examining the Individual Response to a Low-Sodium Diet in Patients with Hypertension: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 13;12:e39058. doi: 10.2196/39058.
PubMed 36780210
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Individual Response to a Restricted Sodium Diet in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT04764253
- Acronym / sponsor ID
- HSC20200504H
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 21 Feb 2021 (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.
Excessive dietary sodium intake is an independent risk factor for hypertension and cardiovascular disease. A vast array of efforts have tried to reduce sodium consumption based on evidence indicating a public health benefit. Yet this benefit has been questioned, mainly based on studies showing variability in individual responses to a sodium-restricted diet (SRD). The effects of an SRD on blood pressure vary, and adherence to an SRD is not optimal. The original Sodium Watchers Program (R01NR012967) was developed and implemented by Dr. Misook Chung (University of Kentucky). In this pilot study, the modified Sodium Watchers Program will propose improving adherence to an SRD through education and digital self-monitoring for daily sodium intake and blood pressure.
In addition, few studies have examined individuals' metabolic responses to the SRD. In a secondary analysis, we further will examine genetic variants associated with salt sensitivity and whether such a genetic component is associated with sodium excretion and BP control.
A total of 40 hypertensive patients will be randomly assigned to the intervention (n=20) or control group (n=20). The intervention group will receive 8-week education sessions remotely using a video conferencing program. All participants will collect a 24-hour urine specimen for sodium excretion and a total of 4.0ml of peripheral blood will be drawn for salt sensitivity during baseline visit. All participants will be asked to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Sodium Watcher Program + Digital Self-Monitoring | Experimental | Behavioral: Modified Sodium Watcher Program + Digital Self-Monitoring |
| Usual care + Digital Self-Monitoring | Active comparator | Behavioral: Usual care + Digital Self-Monitoring |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 80-99 mmHg, whether or not taking blood pressure medications.
- Smartphone with a data plan
- Valid email address
- Willing and able to participate in online study videoconferencing visits (Zoom)
- Reads and writes in English
Key exclusion criteria (9 listed)
- Participating in another related research study
- Cardiovascular disease event (e.g. stroke, myocardial infarction) in prior 6 months
- Active cancer
- Recent hospitalization due to psychiatric condition or event
- Pregnancy or breastfeeding - current or planned during the study period
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 |
|---|---|---|
| Modified Sodium Watcher Program + Digital Self-MonitoringParticipants randomized to the experimental group will be asked to follow the modified Sodium Watchers Program intervention along with goal setting for low salt foods. Each participant will be registered to assign a unique ID in the Connected Health Platform developed by the Center on Smart and Connected Health Technologies at UT Health Science Center San Antonio and each account from the individuals' wireless and wearable devices (Fitbit and BP monitor) will be connected to his or her unique ID through this platform. Participants will be instructed to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor. Through the Connected Health Platform, the Fitbit app and BP monitor will transmit the data of the intervention group to the research team. | Behavioural | Modified Sodium Watcher Program + Digital Self-Monitoring |
| Usual care + Digital Self-MonitoringParticipants randomized to the control group will be asked to follow usual care which is based on their routine medical and nursing care for hypertension that consists of a recommendation to follow a sodium-restricted diet and take medications as prescribed. The participants will receive wireless and wearable devices (Fitbit wristband, BP monitor). Each participant will be registered to assign a unique ID in the Connected Health Platform at the baseline and each account from the individual's wireless and wearable devices (Fitbit and BP monitor) will be connected to their unique ID through this platform. Participants will be instructed to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor. | Behavioural | Usual care + Digital Self-Monitoring |
Primary outcome
Change in blood pressure over time
Time frame: Up to 8 weeks
Blood pressure (BP) will be measured using a Vital Signs Monitor 300 Series model (WelchAllyn, US). The midsection circumference of the dominant upper arm will be measured with a tape measure, and the proper sized cuff will be selected accordingly. Systolic and diastolic BP will be measured in the dominant arm twice with a 2-minute rest period between measures; two measures will be averaged.
Change in adherence to sodium restricted diet over time
Time frame: Up to 8 weeks
Participants will complete a 24-hour urinary sodium excretion test at baseline and at 8 weeks after the intervention is completed. 24-hour urinary sodium excretion (mg excreted/day) will be tested by collecting all urine excreted over 24 hours. Participants are asked to note the time when they start in a written log, then discard the first urine after that time. They will then collect all urine excreted over the course of the next 24 hours, noting down the time and amount excreted each time in the written log. Urine is stored in a container and does not need refrigeration. 24-hour urine sodium samples will be analyzed by the Center for Renal Precision Medicine laboratory.
4 secondary outcomes
Adherence to dietary sodium intake monitoring
Time frame: Up to 8 weeks
Adherence to In-home BP monitoring
Time frame: Up to 8 weeks
Attendance at education sessions
Time frame: Up to 8 weeks
Retention rate
Time frame: Up to 8 weeks
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 6 Jun 2024.
- Derived from this study: PubMed 36780210Ko J, Wang J, Chung ML, Sharma K. Examining the Individual Response to a Low-Sodium Diet in Patients with Hypertension: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2023 Feb 13;12:e39058. doi: 10.2196/39058.
- Individual participant dataSharing planned: No. No plan at this time.
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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.
Jisook Ko, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Sodium Watcher Program + Digital Self-Monitoring in people with Hypertension, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 9 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 6 Jun 2024. 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 United States. 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?
Change in blood pressure over time (time frame: Up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04764253, which also lists 1 linked publication.
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 6 Jun 2024.