LowSalt4Life: A Mobile Application to Reduce Sodium Intake And Blood Pressure
A Just-In-Time Adaptive Mobile Application Intervention To Reduce Sodium Intake And Blood Pressure In Hypertensive Patients: LowSalt4Life
2 other identifiers
interventional
410
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Aug 2022
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedStudy Start
First participant enrolled
August 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2025
CompletedNovember 18, 2025
November 1, 2025
3.2 years
May 24, 2022
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in systolic blood pressure (SBP)
SBP measured by a wireless home blood pressure monitor
Baseline, 2 months
Secondary Outcomes (5)
Change in weight over 2 months
Baseline, 2 months
Change in estimated sodium intake
Baseline, 2 months
Change in dietary nutrient intake
Baseline, 2 months
Changes in blood pressure (BP) medications
Baseline, 2 months
Percent of participants at a goal blood pressure (BP)
2 months
Study Arms (2)
LowSalt4Life
ACTIVE COMPARATORLowSalt4Life + just-in-time adaptive intervention (JITAI)
EXPERIMENTALInterventions
LowSalt4Life is a dietary sodium intervention mobile application that promotes lower sodium intake.
LowSalt4Life is a dietary sodium application with a just-in-time adaptive intervention (JITAI) component enabled.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brahmajee Nallamothu
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants randomized to the App+JITAI will receive push notifications throughout the study, while those in the App alone group will not. The participants will not be told the group in which they are randomized, but they may know the group because of the number of push notifications.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Stevo Julius Research Professor of Cardiovascular Medicine and Professor of Internal Medicine
Study Record Dates
First Submitted
May 24, 2022
First Posted
May 27, 2022
Study Start
August 15, 2022
Primary Completion
October 31, 2025
Study Completion
October 31, 2025
Last Updated
November 18, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Unique research data be made available to the scientific community after the conclusion of a study. No later than 3 years after the end of the study or 2 years after the main paper reporting the results of the trial, whichever comes first.
- Access Criteria
- The scientific community will have access to the data deposited into the National Heart, Lung, and Blood Institute (NHLBI) supported Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC). Researchers at institutions with a Federal Wide Assurance will be able to gain access to repository data by submitting a data access request in accordance with applicable policies.
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.