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Improving Blood Pressure Control Through the myBPmyLife mHealth Application

Not Applicable
Completed
Conditions
Hypertension
Interventions
Behavioral: Dietary and physical activity JITAI delivered through the myBPmyLife app
Other: Control Group
Registration Number
NCT05154929
Lead Sponsor
University of Michigan
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
608
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.)
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dietary plus physical activity JITAIDietary and physical activity JITAI delivered through the myBPmyLife appParticipants 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.
Control armControl GroupParticipants 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.
Primary Outcome Measures
NameTimeMethod
Change in systolic blood pressure between baseline and 6-monthsBaseline, 6 months
Secondary Outcome Measures
NameTimeMethod
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)
Number of self-reported low-sodium food choices within 24 hours of a diet notificationwithin 24 hours of a diet notification
Change in diastolic blood pressure from baseline to 6-months (i.e., 180 days)Baseline, up to 6 months
Number of steps taken within 60 minutes of a physical activity notificationwithin 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
Trends in weekly systolic BP over the 6-months (i.e., 180 days)Baseline to weekly assessments that are available up to 24 weeks
Change in mean daily step count between baseline and 6-months (i.e., 180 days)Baseline, up to 6 months
Change in quality-of-life between baseline and 6-months as assessed by the single-item Self-Rated Health (SRH) QuestionnaireBaseline, 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.

Trial Locations

Locations (2)

Hamilton Community Health Network

🇺🇸

Flint, Michigan, United States

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

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