Mobile App for Sodium Management for High Blood Pressure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Must be taking: Antihypertensives
Disqualifiers: Unstable BP, Heart failure, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
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 data supports the effectiveness of the LowSalt4Life App treatment for managing high blood pressure?
Research shows that mobile apps can help people manage high blood pressure by improving self-management and encouraging lifestyle changes like reducing sodium intake. Apps like SaltSwitch have been effective in helping users choose lower-salt food options, which can lead to modest reductions in blood pressure.12345
Is the Mobile App for Sodium Management safe for humans?
How is the LowSalt4Life App treatment different from other treatments for high blood pressure?
The LowSalt4Life App is unique because it uses a mobile application to help manage sodium intake, which is a key factor in controlling high blood pressure. Unlike traditional treatments that may focus on medication, this app provides a digital tool for self-management, potentially improving adherence to a low-sodium diet through technology.12357
Eligibility Criteria
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
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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
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Trial Timeline
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
Treatment Details
Interventions
- Just-In-time Adaptive Intervention (JITAI) (Behavioural Intervention)
- LowSalt4Life Application (Behavioural Intervention)
Trial OverviewThe 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).
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: LowSalt4Life + just-in-time adaptive intervention (JITAI)Experimental Treatment2 Interventions
Group II: LowSalt4LifeActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Mobile Apps for the Dietary Approaches to Stop Hypertension (DASH): App Quality Evaluation. [2020]To identify the availability and quality of apps supporting Dietary Approaches to Stop Hypertension (DASH) education.
Effect of Home Blood Pressure Monitoring via a Smartphone Hypertension Coaching Application or Tracking Application on Adults With Uncontrolled Hypertension: A Randomized Clinical Trial. [2020]Mobile applications (apps) may help improve hypertension self-management.
[Mobile applications and management of hypertension: possibilities, problems and perspectives]. [2021]Via the internet smartphones allow the download of applications ("Apps") that can address various requirements of daily life. These technical advances create new opportunities to better meet needs of patients suffering from hypertension. This may apply particularly for medication adherence, blood pressure control and lifestyle-changing activities. At the moment younger users in particular are interested in such technology. From other clinical contexts it is known that text messages via cell phones improve medication adherence. A combination of a smartphone and a blood pressure measurement device with the possibility to electronically collect data is promising as the quality of data may improve. Technology interventions by mobile applications that are supported by education or an additional intervention demonstrate a beneficial impact for the reduction of physical inactivity and/or overweight and obesity. However, it is not clear what parts of the technology or interventions are effective. For future developments it will be important to reduce costs and better meet hardware and software requirements of elderly users.
Development of DASH Mobile: a mHealth lifestyle change intervention for the management of hypertension. [2013]Several landmark studies based on the DASH diet have established the effectiveness of a lifestyle approach to blood pressure control that emphasizes a diet rich in fruits and vegetables with moderate portions of low-fat dairy and lean protein along with increased physical activity and reduced sodium intake. However, this evidence base remains underused due feasibility limitations of implementing these intense in-person interventions and poor engagement with desktop computer based versions. Mobile technologies such as smartphones and wireless sensors have the ability to deliver behavioral interventions in-the-moment and with reduced user burden. DASH Mobile is a new mHealth system being developed to deliver this evidence-based lifestyle intervention to hypertensive patients. The system consists of an Android based "app" that facilitates easy tracking of DASH food portions, integrated Bluetooth blood pressure, weight and pedometer monitoring, goal setting, simple data visualizations and multimedia video clips to train patients in the basic concepts of the lifestyle change plan. At present, the system is undergoing usability testing with a pilot clinical trial planned for Spring 2013.
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. [2023]Even modest reductions in blood pressure (BP) can have an important impact on population-level morbidity and mortality from cardiovascular disease. There are 2 promising approaches: the SaltSwitch smartphone app, which enables users to scan the bar code of a packaged food using their smartphone camera and receive an immediate, interpretive traffic light nutrition label on-screen alongside a list of healthier, lower-salt options in the same food category; and reduced-sodium salts (RSSs), which are an alternative to regular table salt that are lower in sodium and higher in potassium but have a similar mouthfeel, taste, and flavor.
The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice. [2022]In 2021, the open-label randomized HERB-Digital Hypertension 1 (HERB-DH1) trial showed for the first time that hypertension digital therapeutics (a hypertension treatment app) successfully reduced blood pressure (BP) in patients with hypertension. Patients in the digital therapeutics group who used the app and home BP monitoring (HBPM) showed significant and persistent decreases in office, home and ambulatory BP values compared with the control group (who were under physician management using HBPM and lifestyle modifications). The results of the pivotal study led to the first global approval of this app for the treatment of hypertension in Japan in 2022, including medical insurance reimbursement. As a result, this hypertension app is expected to become widely used in the clinical management of all stages of hypertension. The most important remaining research issues include the identification of patients likely to respond to this therapeutic approach and the development of clinical efficacy indices. In addition, guidelines for the appropriate use of hypertension apps in the treatment of hypertension are needed. Next steps include the development and research of digital tools to facilitate the behavioral modifications required to prevent hypertension.
The clinical effects of a new management mode for hypertensive patients: a randomized controlled trial. [2022]The Internet, smartphones, and the application of health technology have great potential for hypertension management. We aim to evaluate a new mode of mobile health management with a social network application to guide blood pressure management in patients with hypertension.