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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2025-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypertension Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Participants randomized to the App+JITAI will receive push notifications throughout the study, while those in the App alone group will not. The participants will not be told the group in which they are randomized, but they may know the group because of the number of push notifications.

Study Groups

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LowSalt4Life

Group Type ACTIVE_COMPARATOR

LowSalt4Life Application

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

LowSalt4Life Application

Intervention Type BEHAVIORAL

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

Just-In-time Adaptive Intervention (JITAI)

Intervention Type BEHAVIORAL

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

Interventions

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LowSalt4Life Application

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

Intervention Type BEHAVIORAL

Just-In-time Adaptive Intervention (JITAI)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No