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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure between baseline and 6-months | Baseline, 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brahmajee K Nallamothu, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| Hamilton Community Health Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40659778 | Derived | 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. | |
| 38226521 |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D015340 | Epidemiologic Research Design |
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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.
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| 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. |
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| 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 |
| Flint |
| Michigan |
| 48505 |
| United States |
| Skolarus 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. |
| 38226507 | Derived | Golbus 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. |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |