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CompletedNCT05396001Updated Nov 18, 2025

LowSalt4Life: A Mobile Application to Reduce Sodium Intake And Blood Pressure

An interventional study of LowSalt4Life Application and Just-In-time Adaptive Intervention (JITAI) in Hypertension and Blood Pressure, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by University of Michigan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
410
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypertension
  • Blood Pressure

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Keywords

  • Dietary sodium
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 410 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. 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
  3. A valid email address
  4. Fluent in spoken and written English

Exclusion criteria

Exclusion Criteria:

  1. Unstable symptoms or markedly elevated blood pressure (BP) at enrollment (defined as systolic BP>180 mmHg, diastolic BP>120 mmHg)
  2. Contraindication to a sodium restriction diet
  3. An estimated sodium intake less than 1,500mg per day
  4. Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma)
  5. Estimated glomerular filtration rate (EGFR) \<30 or end-stage renal disease on dialysis
  6. Heart failure
  7. Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications
  8. Currently pregnant or intent to become pregnant during the study period
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
410 participants (actual)

Study arms

  • Active comparator
    LowSalt4Life

    Behavioral: LowSalt4Life Application

  • Experimental
    LowSalt4Life + just-in-time adaptive intervention (JITAI)

    Behavioral: LowSalt4Life Application · Behavioral: Just-In-time Adaptive Intervention (JITAI)

Interventions

  • BehavioralLowSalt4Life Application

    LowSalt4Life is a dietary sodium intervention mobile application that promotes lower sodium intake.

  • BehavioralJust-In-time Adaptive Intervention (JITAI)

    LowSalt4Life is a dietary sodium application with a just-in-time adaptive intervention (JITAI) component enabled.

06

What researchers measure

Primary outcomes

  1. Change in systolic blood pressure (SBP)

    SBP measured by a wireless home blood pressure monitor

    Time frame: Baseline, 2 months

Secondary outcomes

  1. Change in weight over 2 months

    Weight measured using wireless scale

    Time frame: Baseline, 2 months

  2. Change in estimated sodium intake

    As measured by the Block 2014 Food Frequency Questionnaire

    Time frame: Baseline, 2 months

  3. Change in dietary nutrient intake

    As measured by the Block 2014 Food Frequency Questionnaire

    Time frame: Baseline, 2 months

  4. Changes in blood pressure (BP) medications

    As measured by the electronic health record

    Time frame: Baseline, 2 months

  5. Percent of participants at a goal blood pressure (BP)

    Goal BPs are based on the American Heart Association blood pressure guidelines.

    Time frame: 2 months

07

Study locations

1 site
  • The University of Michigan
    Ann Arbor, Michigan 48109, United States
08

References and documents

Study documents

  • Informed consent form · Feb 10, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05396001
Lead sponsor
University of Michigan
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Brahmajee K Nallamothu (Stevo Julius Research Professor of Cardiovascular Medicine and Professor of Internal Medicine, University of Michigan) — Principal investigator
First posted
May 27, 2022
Start date
Aug 15, 2022
Primary completion
Oct 31, 2025
Completion
Oct 31, 2025
Last update
Nov 18, 2025

Study contacts

Brahmajee Nallamothu
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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