Skip to main content
OpenTrials
Completed

NCT Number: NCT05154929

Improving Blood Pressure Control Through the myBPmyLife mHealth Application

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Motor Activity Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary and physical activity JITAI delivered through the myBPmyLife app

Behavioral

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.

Control Group

Other

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.

Primary outcomes

  1. Change in systolic blood pressure between baseline and 6-months

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Number of self-reported low-sodium food choices within 24 hours of a diet notification

    Time frame: within 24 hours of a diet notification

  2. Number of steps taken within 60 minutes of a physical activity notification

    Time frame: within 60 minutes of a physical activity notification

  3. Change in mean daily sodium intake between baseline and 6-months (Block Sodium Screener)

    Time frame: Baseline, up to 6 months

  4. Change in mean daily step count between baseline and 6-months (i.e., 180 days)

    Time frame: Baseline, up to 6 months

  5. Change in diastolic blood pressure from baseline to 6-months (i.e., 180 days)

    Time frame: Baseline, up to 6 months

  6. Trends in weekly systolic BP over the 6-months (i.e., 180 days)

    Time frame: Baseline to weekly assessments that are available up to 24 weeks

  7. Changes in systolic BP from baseline to 60 days, 120 days, and at 180 days (i.e., approximately 2 months)

    Time frame: Baseline, every 60 days from 0 days to 60 days to 120 days to 180 days (i.e., approximately 2 months)

  8. Change in quality-of-life between baseline and 6-months as assessed by the single-item Self-Rated Health (SRH) Questionnaire

    Time frame: Baseline, up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: myBPmyLife

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.