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

University of Michigan

Status: Completed

Conditions: Hypertension; Blood Pressure

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05396001

HUM00210954

1R61HL155498-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 410 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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410 participants in 2 patient groups

LowSalt4Life

Active Comparator group

Treatment:

Behavioral: LowSalt4Life Application

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

Experimental group

Treatment:

Behavioral: LowSalt4Life Application

Behavioral: Just-In-time Adaptive Intervention (JITAI)