HypertensionNCT05396001
LowSalt4Life: A Mobile Application to Reduce Sodium Intake And Blood Pressure
A study testing LowSalt4Life Application and Just-In-time Adaptive Intervention (JITAI) in people with Hypertension and Blood Pressure, run by University of Michigan at 1 site in United States.
Trial summary
This research is being done to learn if a smartphone app with and without a just in time adaptive intervention (JITAI) can help patients with hypertension manage their sodium intake and improve their blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Blood Pressure
- What is being tested?
- LowSalt4Life Application and Just-In-time Adaptive Intervention (JITAI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 31 Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with essential hypertension (HTN) by a medical provider and are on stable doses of antihypertensive therapy for at least three months prior to enrollment as documented in the electronic health record (EHR) and confirmed by participant self-report.
- A smartphone with a compatible Apple or Android operating system installed and able to download and use LowSalt4Life app including accepting all permissions and willing to allow the mobile applications to send push notifications
- A valid email address
- Fluent in spoken and written English
Who cannot join
- Unstable symptoms or markedly elevated blood pressure (BP) at enrollment (defined as systolic BP>180 mmHg, diastolic BP>120 mmHg)
- Contraindication to a sodium restriction diet
- An estimated sodium intake less than 1,500mg per day
- Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma)
- Estimated glomerular filtration rate (EGFR) <30 or end-stage renal disease on dialysis
- Heart failure
- Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications
- Currently pregnant or intent to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: A Just-In-Time Adaptive Mobile Application Intervention To Reduce Sodium Intake And Blood Pressure In Hypertensive Patients: LowSalt4Life
This research is being done to learn if a smartphone app with and without a just in time adaptive intervention (JITAI) can help patients with hypertension manage their sodium intake and improve their blood pressure.
Read the detailed description
The primary and secondary outcomes will be determined in months 1 \& 2. Participants will continue for another 4 months and during that time data for exploratory measures will be collected.
During the first 2 months of the study, a micro-randomized trial (MRT) will be performed within the App+JITAI group (N=200). This MRT is designed to learn which push notification messages effectively prompt the user to interact with the appropriate content within the mobile application.
- Conditions
- Hypertension, Blood Pressure
- Being tested
- LowSalt4Life Application, Just-In-time Adaptive Intervention (JITAI)
- Keywords
- Dietary sodium
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LowSalt4Life ApplicationBehavioural
LowSalt4Life is a dietary sodium intervention mobile application that promotes lower sodium intake.
Just-In-time Adaptive Intervention (JITAI)Behavioural
LowSalt4Life is a dietary sodium application with a just-in-time adaptive intervention (JITAI) component enabled.
| Study group | Role | What they receive |
|---|---|---|
| LowSalt4Life | Active comparator | Not described Receives: Behavioral: LowSalt4Life Application |
| LowSalt4Life + just-in-time adaptive intervention (JITAI) | Experimental | Not described Receives: Behavioral: LowSalt4Life Application; Behavioral: Just-In-time Adaptive Intervention (JITAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure (SBP)
SBP measured by a wireless home blood pressure monitor
Measured: Baseline, 2 months
Secondary outcomes (5)
Change in weight over 2 months
Weight measured using wireless scale
Measured: Baseline, 2 months
Change in estimated sodium intake
As measured by the Block 2014 Food Frequency Questionnaire
Measured: Baseline, 2 months
Change in dietary nutrient intake
As measured by the Block 2014 Food Frequency Questionnaire
Measured: Baseline, 2 months
Changes in blood pressure (BP) medications
As measured by the electronic health record
Measured: Baseline, 2 months
Percent of participants at a goal blood pressure (BP)
Goal BPs are based on the American Heart Association blood pressure guidelines.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start15 Aug 2022
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Brahmajee K Nallamothu, University of Michigan
- Investigators
- Brahmajee Nallamothu, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396001
- Sponsor's protocol ID
- HUM00210954
- Other IDs
- 1R61HL155498-01A1
- Status last verified
- Nov 2025
- First submitted
- 24 May 2022
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The aim is to prepare data for deposit into the National Heart, Lung, and Blood Institute (NHLBI) supported Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC).Unique research data be made available to the scientific community after the conclusion of a study. The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with National Heart, Lung, and Blood Institute data sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Just-In-Time Adaptive Mobile Application Intervention To Reduce Sodium Intake And Blood Pressure In Hypertensive Patients: LowSalt4Life
- ClinicalTrials.gov ID
- NCT05396001
- Acronym / sponsor ID
- HUM00210954
- Conditions
- Hypertension, Blood Pressure
- Keywords
- Dietary sodium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 27 May 2022 (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.
This research is being done to learn if a smartphone app with and without a just in time adaptive intervention (JITAI) can help patients with hypertension manage their sodium intake and improve their blood pressure.
Detailed description
The primary and secondary outcomes will be determined in months 1 \& 2. Participants will continue for another 4 months and during that time data for exploratory measures will be collected.
During the first 2 months of the study, a micro-randomized trial (MRT) will be performed within the App+JITAI group (N=200). This MRT is designed to learn which push notification messages effectively prompt the user to interact with the appropriate content within the mobile application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LowSalt4Life | Active comparator | Behavioral: LowSalt4Life Application |
| LowSalt4Life + just-in-time adaptive intervention (JITAI) | Experimental | Behavioral: LowSalt4Life Application, Behavioral: Just-In-time Adaptive Intervention (JITAI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with essential hypertension (HTN) by a medical provider and are on stable doses of antihypertensive therapy for at least three months prior to enrollment as documented in the electronic health record (EHR) and confirmed by participant self-report.
- A smartphone with a compatible Apple or Android operating system installed and able to download and use LowSalt4Life app including accepting all permissions and willing to allow the mobile applications to send push notifications
- A valid email address
- Fluent in spoken and written English
Key exclusion criteria (8 listed)
- Unstable symptoms or markedly elevated blood pressure (BP) at enrollment (defined as systolic BP>180 mmHg, diastolic BP>120 mmHg)
- Contraindication to a sodium restriction diet
- An estimated sodium intake less than 1,500mg per day
- Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma)
- Estimated glomerular filtration rate (EGFR) <30 or end-stage renal disease on dialysis
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 |
|---|---|---|
| LowSalt4Life ApplicationLowSalt4Life is a dietary sodium intervention mobile application that promotes lower sodium intake. | Behavioural | LowSalt4Life, LowSalt4Life + just-in-time adaptive intervention (JITAI) |
| Just-In-time Adaptive Intervention (JITAI)LowSalt4Life is a dietary sodium application with a just-in-time adaptive intervention (JITAI) component enabled. | Behavioural | LowSalt4Life + just-in-time adaptive intervention (JITAI) |
Primary outcome
Change in systolic blood pressure (SBP)
Time frame: Baseline, 2 months
SBP measured by a wireless home blood pressure monitor
5 secondary outcomes
Change in weight over 2 months
Time frame: Baseline, 2 months
Change in estimated sodium intake
Time frame: Baseline, 2 months
Change in dietary nutrient intake
Time frame: Baseline, 2 months
Changes in blood pressure (BP) medications
Time frame: Baseline, 2 months
Percent of participants at a goal blood pressure (BP)
Time frame: 2 months
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 18 Nov 2025.
- Individual participant dataSharing planned: Yes. The aim is to prepare data for deposit into the National Heart, Lung, and Blood Institute (NHLBI) supported Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC).Unique research data be made available to the scientific community after the conclusion of a study. The de-identified analytic data will be prepared as SAS transport files or ASCII comma-delimited files with accompanying codebooks that describe the data and data structure. The redaction will employ best practices and will be consistent with National Heart, Lung, and Blood Institute data sharing policies.
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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.
Brahmajee Nallamothu principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LowSalt4Life Application and Just-In-time Adaptive Intervention (JITAI) in people with Hypertension and Blood Pressure, run by University of Michigan 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 4 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 18 Nov 2025. 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 systolic blood pressure (SBP) (time frame: Baseline, 2 months). 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 18 Nov 2025.