Status:
COMPLETED
LowSalt4Life: A Mobile Application to Reduce Sodium Intake And Blood Pressure
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypertension
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT05396001
Start Date
August 15 2022
End Date
October 31 2025
Last Update
November 18 2025
Active Locations (1)
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1
The University of Michigan
Ann Arbor, Michigan, United States, 48109