Blood Pressure, Hypertension
Conditions
Keywords
Dietary sodium
Brief summary
This research is being done to learn if a smartphone app with and without a just in time adaptive intervention (JITAI) can help patients with hypertension manage their sodium intake and improve their blood pressure.
Detailed description
The primary and secondary outcomes will be determined in months 1 & 2. Participants will continue for another 4 months and during that time data for exploratory measures will be collected. During the first 2 months of the study, a micro-randomized trial (MRT) will be performed within the App+JITAI group (N=200). This MRT is designed to learn which push notification messages effectively prompt the user to interact with the appropriate content within the mobile application.
Interventions
BEHAVIORALLowSalt4Life Application
LowSalt4Life is a dietary sodium intervention mobile application that promotes lower sodium intake.
LowSalt4Life is a dietary sodium application with a just-in-time adaptive intervention (JITAI) component enabled.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants randomized to the App+JITAI will receive push notifications throughout the study, while those in the App alone group will not. The participants will not be told the group in which they are randomized, but they may know the group because of the number of push notifications.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with essential hypertension (HTN) by a medical provider and are on stable doses of antihypertensive therapy for at least three months prior to enrollment as documented in the electronic health record (EHR) and confirmed by participant self-report. 2. A smartphone with a compatible Apple or Android operating system installed and able to download and use LowSalt4Life app including accepting all permissions and willing to allow the mobile applications to send push notifications 3. A valid email address 4. Fluent in spoken and written English
Exclusion criteria
1. Unstable symptoms or markedly elevated blood pressure (BP) at enrollment (defined as systolic BP\>180 mmHg, diastolic BP\>120 mmHg) 2. Contraindication to a sodium restriction diet 3. An estimated sodium intake less than 1,500mg per day 4. Known secondary causes of HTN (e.g., adrenal insufficiency, pheochromocytoma) 5. Estimated glomerular filtration rate (EGFR) \<30 or end-stage renal disease on dialysis 6. Heart failure 7. Inability to use Withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications 8. Currently pregnant or intent to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure (SBP) | Baseline, 2 months | SBP measured by a wireless home blood pressure monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight over 2 months | Baseline, 2 months | Weight measured using wireless scale |
| Change in estimated sodium intake | Baseline, 2 months | As measured by the Block 2014 Food Frequency Questionnaire |
| Change in dietary nutrient intake | Baseline, 2 months | As measured by the Block 2014 Food Frequency Questionnaire |
| Changes in blood pressure (BP) medications | Baseline, 2 months | As measured by the electronic health record |
| Percent of participants at a goal blood pressure (BP) | 2 months | Goal BPs are based on the American Heart Association blood pressure guidelines. |
Countries
United States
Outcome results
None listed