Improving Blood Pressure Control Through the myBPmyLife mHealth Application (myBPmyLife)

Improving Blood Pressure Control Through the myBPmyLife mHealth Application: A Wearables in Reducing Risk and Enhancing Daily Lifestyle (WIRED-L) Center Study

This study is enrolling eligible participants that have high blood pressure. Reducing dietary salt intake and engaging in regular physical activity is known to decrease blood pressure in people with hypertension. This trial will determine whether a smartwatch and a mobile health application, which together deliver notifications, can increase activity levels and reduce salt intake for people with high blood pressure. All study activities will be completed online or via a mobile medical application. Participants will not have any face-to-face visits with the study team.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Control Group; Behavioral: Dietary and physical activity JITAI delivered through the myBPmyLife app

• Study Type: Interventional
• Enrollment (Actual): 608
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Flint, Michigan, United States, 48505
      • Hamilton Community Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Self-reported history of hypertension and no hypertensive medication changes in the last 4 weeks.
• A smartphone with a compatible Apple or Android operating system installed and able to download and use the myBPmyLife app including accepting all permissions
• A valid email address
• Fluent in spoken and written English
• Signed written informed consent. (Note that each participant must be able to consent for themselves.)

Exclusion Criteria:

• Contraindication to performing physical activity or following a sodium restriction diet. The participant must be able to walk and eat on their own without assistive devices.
• Unstable symptoms or markedly elevated BP at enrollment (defined as systolic BP>180 mmHg, diastolic BP>120 millimeters of mercury (mmHg))
• Known secondary causes of hypertension (e.g., adrenal insufficiency, pheochromocytoma), heart failure, or end-stage renal disease
• Difficulty using an upper arm blood pressure cuff due to biceps size or end-stage renal disease or difficulty comfortably wearing a smartwatch
• Wrist too large to wear a smartwatch comfortably.
• Daily sodium intake less than 1500 mg/day as measured by the sodium screener
• Currently pregnant or planning to become pregnant in the next six months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control arm; Participants in the control group will be provided a smartwatch and home blood pressure monitor. They will also be provided with general instructions on how to download and install a physical activity and diet regulation applications (apps) available to the general public. They will still be asked to perform the blood pressure monitoring at regularly scheduled time periods, but do not receive the intervention components notifications in myBPmyLife app developed for the experimental group.	Other: Control Group; Participants will receive the myBPmyLife app, a smartwatch, and blood pressure cuff. The myBPmyLife app will not be fully activated (as they are in the control arm). They will be provided with the option of downloading and installing a mHealth app that is publicly available. In this arm they will also perform the blood pressure monitoring, but do not receive the intervention components through the myBPmyLife app.
Experimental: Dietary plus physical activity JITAI; Participants in the experimental group will be provided a smarthwatch and home blood pressure monitor. They will then receive the myBPmyLife app that includes push notifications to promote increased physical activity and improve low sodium food choices. The app also provides goal setting for weekly step count and information on low-sodium food choices, as well as feedback on achieving the goals using a dashboard with visualization tools within the mobile application.	Behavioral: Dietary and physical activity JITAI delivered through the myBPmyLife app; A Fitbit smartwatch and home blood pressure monitor will be mailed to participants (in both the experimental and control arms). Participants in the intervention arm then will set up and utilize the myBPmyLife app. This app includes push notifications to promote increased physical activity and improve low-sodium food choices, establish goal setting for weekly step count and low sodium food choices, and deliver feedback on achieving the goals using a dashboard visualization within the mobile application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in systolic blood pressure between baseline and 6-months	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of self-reported low-sodium food choices within 24 hours of a diet notification		within 24 hours of a diet notification
Number of steps taken within 60 minutes of a physical activity notification		within 60 minutes of a physical activity notification
Change in mean daily sodium intake between baseline and 6-months (Block Sodium Screener)		Baseline, up to 6 months
Change in mean daily step count between baseline and 6-months (i.e., 180 days)		Baseline, up to 6 months
Change in diastolic blood pressure from baseline to 6-months (i.e., 180 days)		Baseline, up to 6 months
Trends in weekly systolic BP over the 6-months (i.e., 180 days)		Baseline to weekly assessments that are available up to 24 weeks
Changes in systolic BP from baseline to 60 days, 120 days, and at 180 days (i.e., approximately 2 months)		Baseline, every 60 days from 0 days to 60 days to 120 days to 180 days (i.e., approximately 2 months)
Change in quality-of-life between baseline and 6-months as assessed by the single-item Self-Rated Health (SRH) Questionnaire	Change in the proportion of SRH responses from baseline to 6-months (i.e., 180 days) across 2 categories: 1) excellent, very good or good versus 2) fair or poor.	Baseline, up to 6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Brahmajee K Nallamothu, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Actual): January 27, 2024
• Study Completion (Actual): January 27, 2024

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: exercise; mobile application; high blood pressure; smartwatch; decrease salty food
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HUM00205845

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No