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

Not Applicable

Recruiting

• Conditions: Hypertension; Blood Pressure
• Interventions: Behavioral: LowSalt4Life Application; Behavioral: Just-In-time Adaptive Intervention (JITAI)

• Registration Number: NCT05396001
• Lead Sponsor: University of Michigan

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 blood pressure.

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 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.

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2022-08-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LowSalt4Life + just-in-time adaptive intervention (JITAI)	Just-In-time Adaptive Intervention (JITAI)	-
LowSalt4Life	LowSalt4Life Application	-
LowSalt4Life + just-in-time adaptive intervention (JITAI)	LowSalt4Life Application	-

Primary Outcome Measures

Name	Time	Method
Change in systolic blood pressure (SBP)	Baseline, 2 months	SBP measured by a wireless home blood pressure monitor

Secondary Outcome Measures

Name	Time	Method
Change in weight over 2 months	Baseline, 2 months	Weight measured using wireless scale
Percent of participants at a goal blood pressure (BP)	2 months	Goal BPs are based on the American Heart Association blood pressure guidelines.
Changes in blood pressure (BP) medications	Baseline, 2 months	As measured by the electronic health record
Change in estimated sodium intake	Baseline, 2 months	As measured by the Block 2014 Food Frequency Questionnaire
Change in dietary nutrient intake	Baseline, 2 months	As measured by the Block 2014 Food Frequency Questionnaire

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States