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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05396001
• Other study ID #: HUM00210954
• Secondary ID: 1R61HL155498-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: November 2025

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Sabah Ganai
• Phone: 734-763-5317
• Email: sganai[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 blood pressure.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Behavioral:
• LowSalt4Life Application
LowSalt4Life is a dietary sodium intervention mobile application that promotes lower sodium intake.
• Just-In-time Adaptive Intervention (JITAI)
LowSalt4Life is a dietary sodium application with a just-in-time adaptive intervention (JITAI) component enabled.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure (SBP)	SBP measured by a wireless home blood pressure monitor	Baseline, 2 months
Secondary	Change in weight over 2 months	Weight measured using wireless scale	Baseline, 2 months
Secondary	Change in estimated sodium intake	As measured by the Block 2014 Food Frequency Questionnaire	Baseline, 2 months
Secondary	Change in dietary nutrient intake	As measured by the Block 2014 Food Frequency Questionnaire	Baseline, 2 months
Secondary	Changes in blood pressure (BP) medications	As measured by the electronic health record	Baseline, 2 months
Secondary	Percent of participants at a goal blood pressure (BP)	Goal BPs are based on the American Heart Association blood pressure guidelines.	2 months