HypertensionmyBPmyLifeNCT05154929
Improving Blood Pressure Control Through the myBPmyLife mHealth Application
A study testing Dietary and physical activity JITAI delivered through the myBPmyLife app in people with Hypertension, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Dietary and physical activity JITAI delivered through the myBPmyLife app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 608 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2021to 27 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Hamilton Community Health Network
Flint, Michigan, 48505
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Dietary and physical activity JITAI delivered through the myBPmyLife app, Control Group
- Keywords
- high blood pressure, exercise, decrease salty food, smartwatch, mobile application
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and physical activity JITAI delivered through the myBPmyLife appBehavioural
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | 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. Receives: Other: Control Group |
| Dietary plus physical activity JITAI | Experimental | 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. Receives: Behavioral: Dietary and physical activity JITAI delivered through the myBPmyLife app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure between baseline and 6-months
Measured: Baseline, 6 months
Secondary outcomes (8)
Number of self-reported low-sodium food choices within 24 hours of a diet notification
Measured: within 24 hours of a diet notification
Number of steps taken within 60 minutes of a physical activity notification
Measured: within 60 minutes of a physical activity notification
Change in mean daily sodium intake between baseline and 6-months (Block Sodium Screener)
Measured: Baseline, up to 6 months
Change in mean daily step count between baseline and 6-months (i.e., 180 days)
Measured: Baseline, up to 6 months
Change in diastolic blood pressure from baseline to 6-months (i.e., 180 days)
Measured: Baseline, up to 6 months
Trends in weekly systolic BP over the 6-months (i.e., 180 days)
Measured: 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)
Measured: 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.
Measured: Baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start21 Dec 2021
- Primary completion27 Jan 2024
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter 6 month randomized controlled clinical trial. This study will investigate the efficacy of two just-in-time adaptive interventions (JITAIs) delivered via a mobile app for patients with hypertension. Eligible participants will be randomized to the two JITAIs or control in a 1:1 manner stratified by site. There will be two sites: the University of Michigan Health System in Ann Arbor and the Hamilton Community Health Network Clinic in Flint.
- Masking
- None (open label)
- Enrolment
- 608 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Brahmajee K Nallamothu, University of Michigan
- Investigators
- Brahmajee K Nallamothu, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154929
- Sponsor's protocol ID
- HUM00205845
- Acronym
- myBPmyLife
- Status last verified
- Feb 2024
- First submitted
- 30 Nov 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dorsch MP, Golbus JR, Stevens R, Trumpower B, Basu T, Luff E, Warden K, Giacalone M, Bailey S, Rubick GV, Mishra S, Klasnja P, Newman MW, Skolarus LE, Nallamothu BK. Physical activity and diet just-in-time adaptive intervention to reduce blood pressure: a randomized controlled trial. NPJ Digit Med. 2025 Jul 14;8(1):438. doi: 10.1038/s41746-025-01844-3.
PubMed 40659778Skolarus LE, Farhan Z, Mishra SR, Rao N, Bowie K, Bailey S, Dorsch MP, Newman MW, Nallamothu BK, Golbus JR. Resource Requirements for Participant Enrollment From a University Health System and a Federally Qualified Health Center Network in a Mobile Health Study: The myBPmyLife Trial. J Am Heart Assoc. 2024 Jan 16;13(2):e030825. doi: 10.1161/JAHA.123.030825. Epub 2024 Jan 16. No abstract available.
PubMed 38226521Golbus JR, Jeganathan VSE, Stevens R, Ekechukwu W, Farhan Z, Contreras R, Rao N, Trumpower B, Basu T, Luff E, Skolarus LE, Newman MW, Nallamothu BK, Dorsch MP. A Physical Activity and Diet Just-in-Time Adaptive Intervention to Reduce Blood Pressure: The myBPmyLife Study Rationale and Design. J Am Heart Assoc. 2024 Jan 16;13(2):e031234. doi: 10.1161/JAHA.123.031234. Epub 2024 Jan 16.
PubMed 38226507
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Blood Pressure Control Through the myBPmyLife mHealth Application: A Wearables in Reducing Risk and Enhancing Daily Lifestyle (WIRED-L) Center Study
- ClinicalTrials.gov ID
- NCT05154929
- Acronym / sponsor ID
- myBPmyLife / HUM00205845
- Conditions
- Hypertension
- Keywords
- high blood pressure, exercise, decrease salty food, smartwatch, mobile application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 608 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 27 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a multicenter 6 month randomized controlled clinical trial. This study will investigate the efficacy of two just-in-time adaptive interventions (JITAIs) delivered via a mobile app for patients with hypertension. Eligible participants will be randomized to the two JITAIs or control in a 1:1 manner stratified by site. There will be two sites: the University of Michigan Health System in Ann Arbor and the Hamilton Community Health Network Clinic in Flint.
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Other: Control 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. |
| Dietary plus physical activity JITAI | Experimental | Behavioral: Dietary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary and physical activity JITAI delivered through the myBPmyLife appA 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. | Behavioural | Dietary plus physical activity JITAI |
| Control GroupParticipants 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. | Other | Control arm |
Primary outcome
Change in systolic blood pressure between baseline and 6-months
Time frame: Baseline, 6 months
8 secondary outcomes
Number of self-reported low-sodium food choices within 24 hours of a diet notification
Time frame: within 24 hours of a diet notification
Number of steps taken within 60 minutes of a physical activity notification
Time frame: within 60 minutes of a physical activity notification
Change in mean daily sodium intake between baseline and 6-months (Block Sodium Screener)
Time frame: Baseline, up to 6 months
Change in mean daily step count between baseline and 6-months (i.e., 180 days)
Time frame: Baseline, up to 6 months
Change in diastolic blood pressure from baseline to 6-months (i.e., 180 days)
Time frame: Baseline, up to 6 months
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
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 40659778Dorsch MP, Golbus JR, Stevens R, Trumpower B, Basu T, Luff E, Warden K, Giacalone M, Bailey S, Rubick GV, Mishra S, Klasnja P, Newman MW, Skolarus LE, Nallamothu BK. Physical activity and diet just-in-time adaptive intervention to reduce blood pressure: a randomized controlled trial. NPJ Digit Med. 2025 Jul 14;8(1):438. doi: 10.1038/s41746-025-01844-3.
- Derived from this study: PubMed 38226521Skolarus LE, Farhan Z, Mishra SR, Rao N, Bowie K, Bailey S, Dorsch MP, Newman MW, Nallamothu BK, Golbus JR. Resource Requirements for Participant Enrollment From a University Health System and a Federally Qualified Health Center Network in a Mobile Health Study: The myBPmyLife Trial. J Am Heart Assoc. 2024 Jan 16;13(2):e030825. doi: 10.1161/JAHA.123.030825. Epub 2024 Jan 16. No abstract available.
- Derived from this study: PubMed 38226507Golbus JR, Jeganathan VSE, Stevens R, Ekechukwu W, Farhan Z, Contreras R, Rao N, Trumpower B, Basu T, Luff E, Skolarus LE, Newman MW, Nallamothu BK, Dorsch MP. A Physical Activity and Diet Just-in-Time Adaptive Intervention to Reduce Blood Pressure: The myBPmyLife Study Rationale and Design. J Am Heart Assoc. 2024 Jan 16;13(2):e031234. doi: 10.1161/JAHA.123.031234. Epub 2024 Jan 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brahmajee K Nallamothu, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary and physical activity JITAI delivered through the myBPmyLife app in people with Hypertension, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure between baseline and 6-months (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05154929, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.