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OpenTrials
Completed

NCT Number: NCT05396001

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

LowSalt4Life Application

Behavioral

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

Just-in-time adaptive intervention (JITAI)

Behavioral

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

Primary outcomes

  1. Change in systolic blood pressure (SBP)

    Time frame: Baseline, 2 months

    SBP measured by a wireless home blood pressure monitor

Secondary outcomes

  1. Change in weight over 2 months

    Time frame: Baseline, 2 months

    Weight measured using wireless scale

  2. Change in estimated sodium intake

    Time frame: Baseline, 2 months

    As measured by the Block 2014 Food Frequency Questionnaire

  3. Change in dietary nutrient intake

    Time frame: Baseline, 2 months

    As measured by the Block 2014 Food Frequency Questionnaire

  4. Changes in blood pressure (BP) medications

    Time frame: Baseline, 2 months

    As measured by the electronic health record

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

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Just-In-Time Adaptive Mobile Application Intervention To Reduce Sodium Intake And Blood Pressure In Hypertensive Patients: LowSalt4Life

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 27, 2022
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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