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.
Conditions:
🦠 Hypertension 🦠 Blood Pressure
🗓️ Study Start (Actual) 15 August 2022
🗓️ Primary Completion (Estimated) 30 November 2025
✅ Study Completion (Estimated) 30 November 2025
👥 Enrollment (Estimated) 400
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    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:

    • 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 May 2022
  • First Submitted that Met QC Criteria 24 May 2022
  • First Posted 27 May 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 June 2024
  • Last Update Posted 24 June 2024
  • Last Verified June 2024