Mobile App for Sodium Management for High Blood Pressure

Overseen By Sabah Ganai

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Antihypertensives

Disqualifiers: Unstable BP, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called LowSalt4Life to determine if it can help people with high blood pressure manage their salt intake and improve their blood pressure. Participants are divided into two groups: one uses just the app, while the other uses the app with additional support through just-in-time adaptive intervention (JITAI), which provides timely reminders and tips. Eligible participants must have had stable high blood pressure treatment for at least three months and be able to use a smartphone app. They should be comfortable receiving notifications and must not have extremely high blood pressure or other serious health issues. As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage high blood pressure using technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have been on stable doses of your blood pressure medication for at least three months before joining.

What prior data suggests that this mobile app is safe for managing sodium intake in patients with high blood pressure?

Research shows that the LowSalt4Life app, combined with a personalized support system called JITAI, has been tested in people with high blood pressure. In earlier studies, participants using the app significantly reduced their salt intake, which can help lower blood pressure. The app appears safe, with no major safety issues reported. JITAI, which provides tailored advice, also helped participants manage their salt intake and blood pressure effectively. No major side effects were reported, suggesting these digital tools are safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LowSalt4Life mobile app because it offers a fresh, tech-savvy approach to managing sodium intake, crucial for controlling high blood pressure. Unlike traditional methods like dietary counseling or medication, this app provides real-time, personalized guidance, making it easier for users to track and reduce their sodium consumption. One treatment arm even incorporates a just-in-time adaptive intervention (JITAI), which delivers timely, customized suggestions based on the user’s behavior and needs. This innovative use of technology aims to empower individuals to make healthier choices and manage their blood pressure more effectively.

What evidence suggests that this trial's treatments could be effective for managing high blood pressure?

Research shows that the LowSalt4Life app, available to participants in this trial, can help reduce salt intake, which directly lowers blood pressure. One study found that using apps like LowSalt4Life improved the systolic blood pressure over two months. Another treatment arm in this trial combines the LowSalt4Life app with just-in-time adaptive interventions (JITAI). Studies suggest that JITAI can encourage reduced salt consumption and increased physical activity. Although JITAI alone didn't directly improve blood pressure, it promoted healthier habits that can enhance heart health. Overall, these tools assist users in making healthier daily choices, potentially improving blood pressure and heart health. ^{1 2 3 6 7}

Who Is on the Research Team?

Brahmajee K Nallamothu, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with stable high blood pressure, who've been on the same hypertension meds for at least three months. They must own a smartphone compatible with the LowSalt4Life app and be willing to receive notifications. People with unstable blood pressure, secondary causes of hypertension, heart failure, certain kidney issues or those pregnant can't participate.

Inclusion Criteria

Owns 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

I have a smartphone that can download and use the LowSalt4Life app.

Fluent in spoken and written English

Exclusion Criteria

I do not have conditions like adrenal insufficiency or pheochromocytoma causing my high blood pressure.

I have heart failure.

Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the LowSalt4Life app with or without JITAI for sodium intake and blood pressure management

2 months

Virtual interactions via app

Micro-randomized trial (MRT)

MRT conducted within the App+JITAI group to evaluate push notification effectiveness

2 months

Exploratory Data Collection

Participants continue app usage for additional data collection on exploratory measures

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Just-In-time Adaptive Intervention (JITAI)
• LowSalt4Life Application

Trial Overview

The study tests if a mobile app called LowSalt4Life can help manage sodium intake and lower blood pressure in hypertensive patients. It will compare the effectiveness of the app alone versus the app combined with JITAI (just-in-time adaptive intervention).

How Is the Trial Designed?

Group I: LowSalt4Life + just-in-time adaptive intervention (JITAI) Experimental Treatment 2 Interventions

Group II: LowSalt4Life Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study involving 333 participants with uncontrolled hypertension, a smartphone coaching app aimed at promoting self-management did not significantly lower systolic blood pressure compared to a standard blood pressure tracking app after 6 months, with both groups showing similar blood pressure levels.

However, participants using the coaching app reported greater self-confidence in managing their blood pressure, suggesting potential psychological benefits that could support long-term hypertension management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Home Blood Pressure Monitoring via a Smartphone Hypertension Coaching Application or Tracking Application on Adults With Uncontrolled Hypertension: A Randomized Clinical Trial. Persell, SD., Peprah, YA., Lipiszko, D., et al.[2020]

A randomized controlled trial involving 120 hypertensive patients showed that using a mobile health management application significantly reduced both systolic and diastolic blood pressure compared to conventional management methods over three months.

The experimental group not only experienced lower blood pressure but also improved self-management behaviors, as indicated by higher scores on the Hypertension Patients Self-Management Behavior Rating Scale after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effects of a new management mode for hypertensive patients: a randomized controlled trial. Sun, YQ., Jia, YP., Lv, JY., et al.[2022]

Smartphone applications can significantly enhance the management of hypertension by improving medication adherence, blood pressure control, and promoting lifestyle changes, especially among younger users.

While technology interventions show promise in reducing physical inactivity and obesity, further research is needed to identify the most effective components of these interventions and to make them more accessible for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile applications and management of hypertension: possibilities, problems and perspectives]. Becker, S., Mitchell, A., Königsmann, T., et al.[2021]

A 12-week trial using the SaltSwitch app and reduced-sodium salts (RSS) did not show a significant reduction in dietary sodium intake among adults with high blood pressure, indicating that the intervention may not have been effective.

Despite most participants reporting usage of the SaltSwitch app and RSS, challenges related to engagement and the COVID-19 pandemic may have limited the study's power to detect a true effect on sodium reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Sodium-Reduction Smartphone App and Reduced-Sodium Salt to Lower Sodium Intake in Adults With Hypertension: Findings From the Salt Alternatives Randomized Controlled Trial. Eyles, H., Grey, J., Jiang, Y., et al.[2023]

A study evaluated 4 DASH (Dietary Approaches to Stop Hypertension) apps, finding that only one paid app scored high in quality, while the free apps generally had lower quality ratings.

The research highlights the need for better development of free DASH apps, as the current options may not effectively support users in managing hypertension through diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. DiFilippo, KN., Huang, WD., Chapman-Novakofski, KM.[2020]

The DASH Mobile system is designed to help hypertensive patients adopt the DASH diet, which emphasizes fruits, vegetables, low-fat dairy, and lean protein, while also promoting physical activity and reducing sodium intake.

This mobile health (mHealth) app aims to make it easier for users to track their diet and health metrics, potentially overcoming the challenges of traditional in-person interventions and improving patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. Mann, DM., Kudesia, V., Reddy, S., et al.[2013]

The HERB-Digital Hypertension 1 trial demonstrated that a hypertension treatment app significantly reduced blood pressure in patients, showing better results than traditional physician management alone.

This app received global approval in Japan in 2022, paving the way for its widespread use in managing hypertension, although further research is needed to identify which patients will benefit most and to establish guidelines for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice. Kario, K., Harada, N., Okura, A.[2022]

Citations

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Physical activity and diet just-in-time adaptive intervention ...

While our mHealth intervention did not improve BP control, it did increase step count and reduce dietary sodium intake. Both changes were ...

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The myBPmyLife study is a just‐in‐time adaptive intervention designed to promote personalized self‐management for patients with hypertension.

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Trial Design A Just-In-Time Adaptive Mobile Application ...

The primary outcome was change in systolic blood pressure (SBP) at 2 months. Secondary outcomes included changes in BP medication, dietary ...

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Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health

JITAI is an intervention design aiming to provide the right type/amount of support, at the right time, by adapting to an individual's changing internal and ...

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jmir.org/2025/1/e69582

Effectiveness of 2 Just-in-Time Adaptive Interventions for ...

Slow breathing improves arterial baroreflex sensitivity and decreases blood pressure in essential hypertension. Hypertension. Oct 2005;46(4): ...

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Physical activity and diet just-in-time adaptive intervention to ...

The objective of the myBPmyLife study is to evaluate the efficacy of a dynamic mobile application-based just-in-time adaptive intervention ( ...

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This review explores the transformative potential of just-in-time adaptive interventions (JITAIs) as a scalable solution for addressing ...